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Page 1 of 16
Breast Cancer – Invasive
This practice algorithm has been specifically developed for MD Anderson using a multidisciplinary approach and taking into consideration circumstances particular to MD Anderson,
including the following: MD Anderson’s specific patient population; MD Anderson’s services and structure; and MD Anderson’s clinical information. Moreover, this algorithm is not
intended to replace the independent medical or professional judgment of physicians or other health care providers. This algorithm should not be used to treat pregnant women.
NOTE: Consider clinical trials as treatment options for eligible patients.
CLINICAL STAGING
INITIAL MULTIDISCIPLINARY
EVALUATION
1
conservation therapy5 with sentinel6 lymph node (SLN) surgery
6
7
● Total mastectomy with SLN surgery with or without reconstruction
8
● Consider neoadjuvant chemotherapy for biologically aggressive
tumors when appropriate. Confirm placement of radio-opaque markers.9
● Breast
2,3
Pathology review
● Bilateral diagnostic mammography
● History and Physical
● CBC, platelets, liver function tests (total
bilirubin, alkaline phosphatase,
transaminases), creatinine
● Diagnostic imaging of breast and regional
nodal basins with FNA of suspicious nodes
● In patients with clinical suspicion of distant
metastasis body imaging4 recommended,
consider for clinical stage IIb and III
● Consider need for genetic counseling,
fertility preservation, and pregnancy testing
● Pre-operative lymphedema education and
screening
●
TREATMENT
Clinical
Stage I
neoadjuvant chemotherapy8 or
neoadjuvant endocrine therapy10
9
● Confirm placement radio-opaque markers
● Consider
Clinical
Stage II/
Stage III
Candidate
for breast
conservation5 at
presentation?
Yes
No
conservation therapy5 with axillary surgery11
● Total mastectomy with axillary lymph node surgery
with or without reconstruction7 or
8
● Consider neoadjuvant chemotherapy (see page 2)
See
Page 2,
Post Surgery
See
Page 3
● Breast
Yes
Positive
nodes?
conservation therapy5 with SLN6 surgery
6
7
● Total mastectomy with SLN surgery with or without reconstruction
8
● Consider neoadjuvant chemotherapy
● Breast
No
See
Page 2,
PostSurgery
There are special circumstances in which these guidelines do not apply. These include, but are not limited to:
● Sarcoma of the breast
● Patients with lupus and scleroderma
● Special histologies (i.e., tubular, medullary, pure papillary, or colloid)
● Lymphoma of the breast
● Patients with limited life expectancy
● Cancer during pregnancy
2
Pathology Review to include:
● Tumor size
● Composite histologic grade
● HER2
● ER, PR receptor status
● Lymphatic/Vascular invasion
● Size of metastasis
● Lymph node status
● Histologic type
● Margin status
● Extracapsular extension
● Focal less than 2 mm or gross greater than 2 mm
3
Consider MD Anderson approved Breast biomarkers http://www.mdanderson.org/education-and-research/resources-for-professionals/clinical-tools-and-resources/practice-algorithms/clin-management-biomarkers-web-algorithm.pdf
4
Body imaging: CT abdomen, bone scan, chest x-ray preferred for initial imaging. CT chest optional. PET-CT for inflammatory breast cancer.
5
Candidates for breast conservation therapy:
● unicentric disease
● tumor to breast size ratio allows for acceptable cosmetic result
● Negative margins
● resolution of any skin edema after systemic therapy
● no evidence of diffuse calcifications on mammogram
● No contraindication to radiotherapy
6
Surgeons with an established record of lymphatic mapping experience for breast cancer (a minimum of 20 cases with an identification rate of greater than 85% and a false negative rate of less than 5%) may consider
sentinel lymph node surgery as the initial and primary means of evaluating nodal status for selected patients who are clinically node negative.
7
For patients with stage II disease requiring post-mastectomy radiation, consider delayed reconstruction. For patients with stage III disease, delayed reconstruction is preferred.
8
See Appendix A - Neoadjuvant/Adjuvant Chemotherapy Options
9
Radio-opaque markers should be placed as close to initiation of therapy as possible if not done at time of diagnosis.
10
See Page 11 for Endocrine Systemic Adjuvant Therapy Options
11
Candidates for limited axillary surgery with a prior biopsy proved axillary lymph node: documented removal of the prior biopsied and clipped lymph node demonstrating no metastases using sentinel lymph node
Department of Clinical Effectiveness V14
dissection with targeted axillary dissection to ensure that lymph node with prior documented carcinoma is removed and tested.
Copyright 2016 The University of Texas MD Anderson Cancer Center
Approved by Executive Committee of the Medical Staff on 06/28/2016
1
Breast Cancer – Invasive
Page 2 of 16
This practice algorithm has been specifically developed for MD Anderson using a multidisciplinary approach and taking into consideration circumstances particular to MD Anderson,
including the following: MD Anderson’s specific patient population; MD Anderson’s services and structure; and MD Anderson’s clinical information. Moreover, this algorithm is not
intended to replace the independent medical or professional judgment of physicians or other health care providers. This algorithm should not be used to treat pregnant women.
NOTE: Consider clinical trials as treatment options for eligible patients.
ADJUVANT THERAPY FOLLOWING SURGERY AS LOCAL TREATMENT
PATHOLOGICAL STAGING
POSTSURGERY
Yes
Meets
Z0011
criteria2?
Yes
●
●
No
Positive
Nodes?
No further axillary surgery
Tumor less than
or equal to 0.5 cm
Completion Axillary Lymph
Node Dissection (ALND)
●
Adjuvant chemotherapy3 with weekly anthracycline/taxane-based regimen5
Anti-HER2 based therapy3 regimen if HER2 positive
Adjuvant endocrine therapy4 if tumor is hormone receptor positive
Consider endocrine therapy4 if tumor is hormone receptor positive
5
● Anti-HER2 based therapy if HER2 positive (consider weekly
paclitaxel as chemotherapy backbone)
●
Consider adjuvant chemotherapy3 for adverse prognostic features6
5
● Use anti-HER2 based therapy for HER2 positive disease (consider weekly
paclitaxel as chemotherapy backbone)
4
● Adjuvant endocrine therapy if tumor is hormone receptor positive
● Consider multi-gene prognostic assays, see Appendix B
●
No
Tumor greater
than 0.5 to 1 cm
●
Tumor
greater 1 cm7
●
●
●
See Page 4
For
Radiotherapy
Options
Consider adjuvant chemotherapy3 when appropriate5
Anti-HER2 based therapy if HER2 positive5
Adjuvant endocrine therapy4 if tumor is hormone receptor positive
Consider multi-gene prognostic assays, see Appendix B
1
There are special circumstances in which these guidelines do not apply. These include, but are not limited to:
● Sarcoma of the breast
● Patients with lupus and scleroderma
● Special histologies (i.e., tubular, medullary, pure papillary, or colloid)
● Lymphoma of the breast
● Patients with limited life expectancy
● Cancer during pregnancy
2
Z0011 criteria: Clinical T1 or T2, N0, M0, lumpectomy and sentinel lymph node surgery, and tumor positive sentinel node (up to two nodes positive on sentinel node surgery) planned for whole breast irradiation and systemic therapy.
3
See Appendix A - Neoadjuvant/Adjuvant Chemotherapy Options
4
See Page 11 for Endocrine Systemic Adjuvant Therapy Options
5
Cardiac evaluation at baseline and as clinically indicated
6
Lymphovascular invasion (LVI), triple receptor negative, High-grade 3.
7
Tumors of favorable histology less than 3.0 cm (tubular, mucinous) can be considered lower risk and treated appropriately.
Copyright 2016 The University of Texas MD Anderson Cancer Center
Department of Clinical Effectiveness V14
Approved by Executive Committee of the Medical Staff on 06/28/2016
1
Breast Cancer – Invasive
Page 3 of 16
This practice algorithm has been specifically developed for MD Anderson using a multidisciplinary approach and taking into consideration circumstances particular to MD Anderson,
including the following: MD Anderson’s specific patient population; MD Anderson’s services and structure; and MD Anderson’s clinical information. Moreover, this algorithm is not
intended to replace the independent medical or professional judgment of physicians or other health care providers. This algorithm should not be used to treat pregnant women.
NOTE: Consider clinical trials as treatment options for eligible patients.
LOCAL TREATMENT
CLINICAL STAGE/
PRESENTATION
Assess tumor size
at least every 6 weeks
and at completion of
systemic treatment
with physical exam
● Imaging with
mammogram and/or
ultrasound at completion
of systemic treatment,
if undergoing breast
conserving surgery
● Consider midtreatment ultrasound
or other imaging at
any point for clinical
suspicion of disease
progression
●
Neoadjuvant systemic
chemotherapy3 OR
neoadjuvant endocrine
therapy4 as clinically
indicated
● If candidate for breast
conservation therapy5
following neoadjuvant
therapy, place radioopaque markers
Yes
Anti-HER2 based
therapy options3,6
HER2
positive?
No
Chemotherapy (or
hormone therapy
options if appropriate)
for HER2-negative
breast cancer3,4,6
Yes
Breast
conservation
therapy
candidate5?
No
1
Breast Conserving Surgery5
● If clinically node negative at
diagnosis, proceed with sentinel node
surgery7 followed by axillary node
surgery if sentinel node is positive
● If clinically node positive, confirmed
by needle biopsy proceed with axillary
node dissection or if limited axillary
nodal disease is no longer evident,
consider SLN biopsy with documented
clip removal and if no metastases
proceed to radiotherapy without
axillary lymph node dissection
Total mastectomy with nodal treatment
as determined by initial nodal status:
● If clinically node negative at
diagnosis, proceed with sentinel node
biopsy7 followed by axillary node
surgery if sentinel node positive
● If clinically node positive, confirmed
by needle biopsy proceed with
axillary node dissection or if limited
axillary nodal disease is no longer
evident, consider SLN biopsy with
documented clip removal and if no
metastases proceed to radiotherapy
without axillary lymph node dissection
● Consider reconstruction and plastic
surgery consult8
See
Pathological
Findings
on Page 4
There are special circumstances in which these guidelines do not apply. These include, but are not limited to:
● Sarcoma of the breast
● Patients with lupus and scleroderma
● Special histologies (i.e., tubular, medullary, pure papillary, or colloid)
● Lymphoma of the breast
● Patients with limited life expectancy
● Cancer during pregnancy
3
See Appendix A - Neoadjuvant/Adjuvant Chemotherapy Options
4
See Page 11 for Endocrine Systemic Adjuvant Therapy Options. Higher risk patients could be considered for post-operative chemotherapy.
5
Candidates for breast conservation therapy:
● unicentric disease
● tumor to breast size ratio allows for acceptable cosmetic result
● margins greater than or equal to 2 mm,
● resolution of any skin edema after systemic therapy ● no evidence of diffuse calcification on mammogram
● No contraindication to radiotherapy
6
Cardiac evaluation at baseline and as clinically indicated
7
Surgeons with an established record of lymphatic mapping experience for breast cancer (a minimum of 20 cases with an identification rate of greater than 85% and a false negative
rate of less than 5%) may consider sentinel lymph node dissection as the initial and primary means of evaluating nodal status for selected patients who are clinically node negative.
8
For patients with stage II disease requiring post-mastectomy radiation, consider delayed reconstruction. For patients with stage III disease, delayed reconstruction is preferred.
Copyright 2016 The University of Texas MD Anderson Cancer Center
Department of Clinical Effectiveness V14
Approved by Executive Committee of the Medical Staff on 06/28/2016
1
Breast Cancer – Invasive
Page 4 of 16
This practice algorithm has been specifically developed for MD Anderson using a multidisciplinary approach and taking into consideration circumstances particular to MD Anderson,
including the following: MD Anderson’s specific patient population; MD Anderson’s services and structure; and MD Anderson’s clinical information. Moreover, this algorithm is not
intended to replace the independent medical or professional judgment of physicians or other health care providers. This algorithm should not be used to treat pregnant women.
NOTE: Consider clinical trials as treatment options for eligible patients.
PATHOLOGICAL
FINDINGS
TREATMENT
●
Stage I - II disease,
with 0-3 involved
lymph node(s)
●
●
From local
treatment
Stage III disease or
4 or more involved
lymph nodes
●
●
Whole breast radiotherapy2 for breast conservation
therapy with or without regional lymphatics.
Consider partial breast radiotherapy for tumors less
than or equal to 3 cm and negative lymph nodes.
XRT consult for consideration of chest wall
radiotherapy with or without regional lymphatics
for patients with total mastectomy and tumor
greater than 5 cm or any positive lymph nodes.
Post mastectomy radiotherapy to chest wall and
regional lymphatics
Whole breast radiotherapy2 with regional
lymphatics for breast conservation therapy
SURVEILLANCE
Physical exam at least every 6 months
10 after year 5
for 5 years, then annually
● If breast conservation therapy, mammogram
of treated breast at 6-12 months, then annually
● Annual gynecologic exam, if receiving tamoxifen
● Assess bone health (See Breast Cancer
Survivorship: Bone Health Algorithm)
● Encourage age appropriate cancer and general
health guidelines
● Educate, screen and refer for lymphedema
management as needed
●
Endocrine therapy3
for hormone receptor
positive tumors sequential
after chemotherapy4 and
local therapy
● Trastuzumab to
complete one year
if HER2-positive tumor
●
1
There are special circumstances in which these guidelines do not apply. These include, but are not limited to:
● Sarcoma of the breast
● Patients with lupus and scleroderma
● Special histologies (i.e., tubular, medullary, pure papillary, or colloid)
● Lymphoma of the breast
● Patients with limited life expectancy
● Cancer during pregnancy
2
Radiotherapy for BCT and post-mastectomy radiation, are generally delivered at completion of chemotherapy. For early stage node negative patients, radiotherapy may be delivered before or after chemotherapy.
3
See Page 11 for Endocrine Systemic Adjuvant Therapy Options
4
See Appendix A - Neoadjuvant/Adjuvant Chemotherapy Options
Copyright 2016 The University of Texas MD Anderson Cancer Center
Department of Clinical Effectiveness V14
Approved by Executive Committee of the Medical Staff on 06/28/2016
1
Page 5 of 16
Breast Cancer – Invasive
This practice algorithm has been specifically developed for MD Anderson using a multidisciplinary approach and taking into consideration circumstances particular to MD Anderson,
including the following: MD Anderson’s specific patient population; MD Anderson’s services and structure; and MD Anderson’s clinical information. Moreover, this algorithm is not
intended to replace the independent medical or professional judgment of physicians or other health care providers. This algorithm should not be used to treat pregnant women.
NOTE: Consider clinical trials as treatment options for eligible patients.
EVALUATION FOR METASTASIS
TREATMENT FOR METASTASIS
Premenopausal
endocrine
options3
Distant
metastasis1,2
ER positive and
bone or soft tissue
metastasis only or
● Limited visceral disease
●
● Biopsy
to confirm
metastatic disease,
histology, ER/PR and
HER2 status
● Bone Scan
● CT, PET/CT or MRI to
encompass chest,
abdomen and pelvis
● Consider chest x-ray
if no CT is performed
● Complete blood count
and chemistries
including renal and
liver function
● Consider CA15-3
as an adjunctive test
for monitoring
response to therapy
HER2
negative
ER negative or
● ER positive and extensive
visceral disease or
● Symptomatic disease
●
●
●
Tamoxifen with or without ovarian ablation
In premenopausal patient following ovarian
ablation use post-menopausal endocrine options
Yes
Non-steroidal aromatase inhibitors with or
without fulvestrant (if no prior aromatase inhibitor
or tamoxifen)
● Tamoxifen (if no prior tamoxifen)
● Letrozole with or without Palbociclib
Second line therapy:
● Exemestane with or without everolimus
● Fulvestrant with or without Palbociclib
● Other endocrine treatments:
● Estrogens
● Progestins ● Androgens
●
Postmenopausal
endocrine
options3
Chemotherapy5 until progressive disease or maximum benefit can
include:
● Anthracyclines based
● Carboplatin
● Ixabepilone
upon lifetime exposure
● Cisplatin
● Taxanes
to anthracyclines
● Eribulin
● Vinorelbine
● Capecitabine
● Gemcitabine
HER2 positive by either Immuno-histochemistry 3+ or FISH
1
Disease
response or
clinical
benefit?4
Continue current
treatment until
progressive disease or
unacceptable toxicity
then consider alternate
endocrine therapy3
No
Failure to respond to 3
sequential regimens or Zubrod
status greater than or equal to 3,
discontinue chemotherapy
Palliative
care
See Page 6
There are special circumstances in which these guidelines do not apply. These include, but are not limited to:
● Sarcoma of the breast
● Patients with lupus and scleroderma
● Special histologies (i.e., tubular, medullary, pure papillary, or colloid)
● Lymphoma of the breast
● Patients with limited life expectancy
● Cancer during pregnancy
2
See Appendix B for scenarios requiring individualized therapy.
3
See Page 11 for Endocrine Systemic Adjuvant Therapy Options. Male patients should be treated similarly to premenopausal patients. Use of aromatase
inhibitors or fulvestrant should be accompanied by androgen deprivation therapy (medical/surgical).
Copyright 2016 The University of Texas MD Anderson Cancer Center
NOTE: All patients with bone metastases and life expectancy greater than
12 weeks should consider after dental evaluation: a bisphosphonate
(creatinine clearance is 30 or greater) or denosumab.
4
Consider breast surgery for patients with limited responding metastatic disease
who have an intact primary.
5
See Appendix A - Neoadjuvant/Adjuvant Chemotherapy Options
ER = Estrogen Receptor FISH = Fluorescence In Situ Hybridization
HER2 = Human Epidermal Growth Factor Receptor 2
PR = Progesterone Receptor
Department of Clinical Effectiveness V14
Approved by Executive Committee of the Medical Staff on 06/28/2016
1
Page 6 of 16
Breast Cancer – Invasive
This practice algorithm has been specifically developed for MD Anderson using a multidisciplinary approach and taking into consideration circumstances particular to MD Anderson,
including the following: MD Anderson’s specific patient population; MD Anderson’s services and structure; and MD Anderson’s clinical information. Moreover, this algorithm is not
intended to replace the independent medical or professional judgment of physicians or other health care providers. This algorithm should not be used to treat pregnant women.
NOTE: Consider clinical trials as treatment options for eligible patients.
TREATMENT FOR METASTASIS
NOTE: All patients with bone metastases and life expectancy greater than
12 weeks should consider after dental evaluation: a bisphosphonate
(creatinine clearance is 30 or greater) or denosumab.
Continued from previous page
HER2 positive
by either
Immunohistochemistry
3+ or FISH
If no prior trastuzumab or greater than 1 year since
adjuvant trastuzumab:
● Taxane chemotherapy plus trastuzumab plus
pertuzumab
● Alternate therapy based on hormone receptor status
if not candidate for anti-HER2 or cytotoxic therapy
If less than 6 to 12 months from adjuvant trastuzumab
or if prior (neo)adjuvant pertuzumab:
● T-DM-1(Ado-trastuzumab emtansine)
2
● Consider HER2 directed therapies
Progressive
disease
Proceed to one of the following regimens, and can follow by
another regimen below if the patient continues to be a
candidate for antineoplastic therapy:
● T-DM1 if not previously given
● Capecitabine plus lapatinib
● Trastuzumab plus lapatanib
● Trastuzumab plus other chemotherapy (preferred
options - Vinorelbine, gemcitabine, capecitabine, eribulin)
3
● Chemotherapy or hormonal therapy (if ER or PR positive)
2
● Consider HER2 directed therapies
Palliative
care
1
There are special circumstances in which these guidelines do not apply. These include, but are not limited to:
● Sarcoma of the breast
● Patients with lupus and scleroderma
● Special histologies (i.e., tubular, medullary, pure papillary, or colloid)
● Lymphoma of the breast
● Patients with limited life expectancy
● Cancer during pregnancy
3
See Appendix A - Neoadjuvant/Adjuvant Chemotherapy Options
2
See Appendix C - Recurrent or Metastatic Breast Cancer Treatment Options
ER = Estrogen Receptor FISH = Fluorescence In Situ Hybridization
HER2 = Human Epidermal Growth Factor Receptor 2
PR = Progesterone Receptor
Copyright 2016 The University of Texas MD Anderson Cancer Center
Department of Clinical Effectiveness V14
Approved by Executive Committee of the Medical Staff on 06/28/2016
1
Page 7 of 16
Breast Cancer – Invasive
This practice algorithm has been specifically developed for MD Anderson using a multidisciplinary approach and taking into consideration circumstances particular to MD Anderson,
including the following: MD Anderson’s specific patient population; MD Anderson’s services and structure; and MD Anderson’s clinical information. Moreover, this algorithm is not
intended to replace the independent medical or professional judgment of physicians or other health care providers. This algorithm should not be used to treat pregnant women.
NOTE: Consider clinical trials as treatment options for eligible patients.
TREATMENT FOR RECURRENCE
EVALUATION FOR LOCAL RECURRENCE
Ipsilateral breast/chest wall
recurrence or ipsilateral regional
recurrence without distant metastasis
Total mastectomy with lymph node
surgery consider sentinel lymph node
surgery if clinically node negative
3,4
● Consider systemic therapy
3
● Consider pre-operative chemotherapy
Yes
Previous
breast
radiotherapy?
Yes
Invasive
histology?
No
(e.g. DCIS)
Breast conservation therapy
with margin assessment, or
● Total mastectomy; lymph
node surgery; radiation
therapy consult
●
Biopsy to confirm
recurrence with:
● Consider body imaging
for invasive recurrence
● If intact breast, bilateral
diagnostic mammogram
● Ultrasound of affected
breast including
regional nodal basins
● Consider preoperative
systemic therapy
2
● Consider biomarkers
No
Yes
Breast
intact?
No
Yes
No
Yes
Consider systemic therapy
No
Radiotherapy to chest wall,
and regional lymphatics
(if not DCIS alone)
Previous
chest wall
radiotherapy?
Surgical resection with
margin assessment
Yes
Resectable?
No
Surveillance and
endocrine therapy if
estrogen receptor positive
Yes
Resectable?
Endocrine therapy4
or HER2-directed
therapy with
or without
chemotherapy3
1
Wide local excision (WLE)
with margin assessment
● Consider neoadjuvant
systemic therapy prior to WLE
●
Consider systemic therapy
● Consider pre-operative
chemotherapy3
●
●
Radiotherapy to chest
wall and regional
lymphatics, if no
previous radiation
Persistent
disease?
Consider additional
systemic therapy
Surveillance and endocrine
therapy if hormone receptor
positive
● Consider chemotherapy
●
No
There are special circumstances in which these guidelines do not apply. These include, but are not limited to:
● Sarcoma of the breast
● Patients with lupus and scleroderma
● Special histologies (i.e., tubular, medullary, pure papillary, or colloid)
● Lymphoma of the breast
● Patients with limited life expectancy
● Cancer during pregnancy
2
Consider MD Anderson approved Breast biomarkers http://www.mdanderson.org/education-and-research/resources-for-professionals/clinical-tools-and-resources/practice-algorithms/clin-management-biomarkers-web-algorithm.pdf
3
See Appendix A - Neoadjuvant/Adjuvant Chemotherapy Options
4
See Page 11 for Endocrine Systemic Adjuvant Therapy Options
Department of Clinical Effectiveness V14
Copyright 2016 The University of Texas MD Anderson Cancer Center
Approved by Executive Committee of the Medical Staff on 06/28/2016
1
Breast Cancer – Invasive
Inflammatory Breast Cancer
Page 8 of 16
This practice algorithm has been specifically developed for MD Anderson using a multidisciplinary approach and taking into consideration circumstances particular to MD Anderson,
including the following: MD Anderson’s specific patient population; MD Anderson’s services and structure; and MD Anderson’s clinical information. Moreover, this algorithm is not
intended to replace the independent medical or professional judgment of physicians or other health care providers. This algorithm should not be used to treat pregnant women.
NOTE: Consider clinical trials as treatment options for eligible patients.
TREATMENT
STAGING
Modified radical mastectomy
● Radiotherapy to chest wall
and regional lymphatics, if
no previous radiation3
4
● Adjuvant endocrine therapy
if tumor is hormone
receptor positive5
HER2
positive
●
HER2 negative:
neoadjuant doxorubicin
and taxane based
chemotherapy2
● HER2 positive:
dual anti-HER2 therapy
containing regimen
with chemotherapy
● Consider clinical trial(s)
●
Stage III2
Stage IV2
(de novo)
Multidisciplinary
evaluation of
response
Yes
Operable?
HER2+
maintenance
therapy
● HER2
● Hormone
receptors
Hormone
receptor
positive
Adjuvant
endocrine
therapy
Yes
No
Additional
systemic
therapy5 with
or without
radiotherapy
Additional systemic
therapy
● Symptom management
(supportive care)
● Consider clinical trial(s)
●
Multidiciplinary
evaluation of
response
Operable?
No
Single/multi-agent systemic therapy
● Symptom management (Supportive care)
● Clinical trials
●
1
There are special circumstances in which these guidelines do not apply. These include, but are not limited to:
● Patients with lupus and scleroderma
● Special histologies (i.e., tubular, medullary, pure papillary, or colloid)
● Patients with limited life expectancy
● Cancer during pregnancy
2
Diagnostic Workup:
● Medical history and physical
● Obtain photograph to establish baseline clinical appearance and follow up medical photography for a treatment response documentation.
● PET scan/CT scan- If PET/CT scan not possible: neck (if clinically indicated) in addition to chest/abdominal pelvic CT with bone scan.
● Obtain skin biopsy and ultrasound guided core biopsy of the tumor (random biopsies if mass not present)
3
Evaluate pathology response:
● Minimal residual disease or pathologic complete response, age over 45 and negative margins, daily radiation to 66 Gy (2 Gy/fraction, primary fields to 50).
● Significant residual disease, age less than 45 or close or positive margins, twice daily radiation to 66 Gy (1.5 Gy per fraction, primary fields to 51).
4
See Page 11 for Endocrine Systemic Adjuvant Therapy Options
5
See Appendix A - Neoadjuvant/Adjuvant Chemotherapy Options
● Sarcoma of the breast
● Lymphoma of the breast
Copyright 2016 The University of Texas MD Anderson Cancer Center
Department of Clinical Effectiveness V14
Approved by Executive Committee of the Medical Staff on 06/28/2016
1
Page 9 of 16
Breast Cancer – Invasive
This practice algorithm has been specifically developed for MD Anderson using a multidisciplinary approach and taking into consideration circumstances particular to MD Anderson,
including the following: MD Anderson’s specific patient population; MD Anderson’s services and structure; and MD Anderson’s clinical information. Moreover, this algorithm is not
intended to replace the independent medical or professional judgment of physicians or other health care providers. This algorithm should not be used to treat pregnant women.
APPENDIX A: Neoadjuvant/Adjuvant Chemotherapy Options2
HER-2 negative disease3
Preferred regimens:
● Doxorubicin and cyclophospamide (AC) either every 3 weeks or every 2 weeks (dose dense) followed or
preceded by weekly paclitaxel x 12, or dose dense paclitaxel every 2 weeks
● Fluorouracil, doxorubicin, and cyclophosphamide (FAC) followed or preceded by weekly paclitaxel
Other regimens4:
● Dose-dense doxorubicin and cyclophospamide (AC) followed or preceded by paclitaxel every 2 weeks
● Docetaxel and cyclophosphamide (TC)
● Dose-dense doxorubicin and cyclophospamide (AC) followed or preceded by docetaxel every 3 weeks
HER-2 positive disease
Preferred regimens:
● Doxorubicin and cyclophospamide (AC) followed by paclitaxel plus trastuzumab and pertuzumab cycles/
days vary
● Docetaxel, carboplatin, trastuzumab (TCH) plus pertuzumab
● For Stage II or higher, consider addition of pertuzumab with chemotherapy portion of regimen.
Other regimens4:
● Weekly paclitaxel plus trastuzumab (for low-risk disease, such as Stage I)
APPENDIX B: Clinical Scenarios Requiring Individualized Therapy
Brain metastases
Ureteral obstruction
● Leptomeningeal disease
● Impending pathologic fracture
● Choroid metastases
● Pathologic fracture
● Extensive local-regional disease
● Pleural effusion
Cord compression
Pericardial effusion
● Plexopathy/radiculopathy
● Biliary obstruction
● Superior vena cava syndrome
● Stage IV NED
● Oligometastasis5
● Pregnancy
●
●
●
●
Copyright 2016 The University of Texas MD Anderson Cancer Center
1
There are special circumstances in which these guidelines do not apply. These include, but are not limited to:
Sarcoma of the breast
● Patients with lupus and scleroderma
Special histologies (i.e., tubular, medullary, pure papillary, or colloid)
Lymphoma of the breast
● Patients with limited life expectancy
Cancer during pregnancy
2
Refer to NCCN Guidelines Version 3.2015. for specific doses and number of cycles.
3
Optimal duration of adjuvant HER-2 therapy is one year.
4
May consider other neoadjuvant/adjuvant regimens per NCCN guidelines
5
Oligometastases – selected patients with isolated metastatic breast cancer may be considered for definitive treatment.
●
●
●
●
Department of Clinical Effectiveness V14
Approved by Executive Committee of the Medical Staff on 06/28/2016
Breast Cancer – Invasive1
Page 10 of 16
This practice algorithm has been specifically developed for MD Anderson using a multidisciplinary approach and taking into consideration circumstances particular to MD Anderson,
including the following: MD Anderson’s specific patient population; MD Anderson’s services and structure; and MD Anderson’s clinical information. Moreover, this algorithm is not
intended to replace the independent medical or professional judgment of physicians or other health care providers. This algorithm should not be used to treat pregnant women.
NOTE: Consider clinical trials as treatment options for eligible patients or other regimens as suggested by NCCN guidelines.
APPENDIX C: Recurrent or Metastatic Breast Cancer Treatment Options
Preferred Single Agents:
Anthracyclines
● Doxorubicin
● Pegylated liposomal doxorubicin
Other Single Agents:
● Cyclophosphamide
● Carboplatin
Taxanes
● Paclitaxel
●
●
Anti-metabolites
● Capecitabine
● Gemcitabine
Docetaxel
Albumin-bound paclitaxel
●
●
Other microtubule inhibitors
● Vinorelbine
● Eribulin
Cisplatin
Epirubicin
●
Ixabepilone
Combination Chemotherapy Regimens:
●
●
●
●
●
FAC/CAF (cyclophosphamide, doxorubicin, and fluorouracil)
FEC (fluorouracil, epirubicin, and cyclophosphamide)
AC (doxorubicin and cyclophosphamide
EC (epirubicin and cyclophosphamide)
CMF (cyclophosphamide, methotrexate, and fluorouracil)
●
●
●
●
Docetaxel and capecitabine
Gemcitabine and paclitaxel)
Gemcitabine and carboplatin
Ixabepilone/capecitabine
First-line Regimens for HER2-positive disease2: (trastuzumab naïve patients or those who recurred after 6 to 12
months after adjuvant trastuzumab)
● Pertuzumab plus trastuzumab and docetaxel
● Pertuzumab plus trastuzumab and paclitaxel
Other Options, but should not be considered preferred first options:
● Trastuzumab with docetaxel
● Trastuzumab with paclitaxel with or without carboplatin
●
●
Trastuzumab with vinorelbine
Trastuzumab with capecitabine
Regimens for trastuzumab-exposed HER2-positive disease2:
● Ado-trastuzumab emtansine (T-DM1) for recurrence (6 to 12 months from adjuvant trastuzumab)
● Lapatinib plus capecitabine
● Trastuzumab plus lapatinib without cytotoxic therapy
● Trastuzumab plus capecitabine
● Trastuzumab plus other agents
Copyright 2016 The University of Texas MD Anderson Cancer Center
1
There are special circumstances in which these guidelines do not apply.
These include, but are not limited to:
● Sarcoma of the breast
● Patients with lupus and scleroderma
● Special histologies (i.e., tubular, medullary, pure papillary, or colloid)
● Lymphoma of the breast
● Patients with limited life expectancy
● Cancer during pregnancy
2
After maximal benefit achieved with chemotherapy, consider continuous anti-HER2
therapy alone, if ER or PR positive in combination with appropriate hormonal
therapy (This does not apply to Ado-trastuzumab emtansine [T-DM1])
Department of Clinical Effectiveness V14
Approved by Executive Committee of the Medical Staff on 06/28/2016
Breast Cancer – Invasive1
Page 11 of 16
This practice algorithm has been specifically developed for MD Anderson using a multidisciplinary approach and taking into consideration circumstances particular to MD Anderson,
including the following: MD Anderson’s specific patient population; MD Anderson’s services and structure; and MD Anderson’s clinical information. Moreover, this algorithm is not
intended to replace the independent medical or professional judgment of physicians or other health care providers. This algorithm should not be used to treat pregnant women.
NOTE: Consider clinical trials as treatment options for eligible patients.
Endocrine Systemic Adjuvant Therapy Options
Yes
Tamoxifen for 5 years with or without
ovarian suppression or ablation
Postmenopausal
after initial
5 years?
Premenopausal
at diagnosis2
No
●
●
●
●
Aromatase inhibitor for 5 years or
Consider tamoxifen for an additional 5 years (10 years total)
Consider tamoxifen for an additional 5 years (10 years total)
No further endocrine therapy
Ovarian ablation plus aromatase
inhibitor for at least 5 years
●
●
Yes
●
●
●
Postmenopausal
at diagnosis
Aromatase
inhibitor an
option3?
●
No
●
●
Aromatase inhibitor for at least 5 years or
Tamoxifen for 2-3 years followed by aromatase inhibitor to complete at least 5 years of endocrine therapy or
Tamoxifen for 2-3 years followed by aromatase inhibitor for at least 5 years or
Aromatase inhibitor for 2-3 years followed by tamoxifen to complete at least 5 years of endocrine therapy
Tamoxifen for 4 ½ to 6 years followed by aromatase inhibitor to for at least 5 years or
Tamoxifen for 4 ½ to 6 years, then consider tamoxifen for an additional at least 5 years for a total of 10 years of endocrine therapy
Tamoxifen for 5 years or
Consider tamoxifen for up to 10 years
1
There are special circumstances in which these guidelines do not apply. These include, but are not limited to:
● Sarcoma of the breast
● Patients with lupus and scleroderma
● Special histologies (i.e., tubular, medullary, pure papillary, or colloid)
● Lymphoma of the breast
● Patients with limited life expectancy
● Cancer during pregnancy
2
Male patients should be treated similarly to premenopausal patients. Use of aromatase inhibitors or fulvestrant should be accompanied by androgen deprivation therapy (medical/surgical).
3
Aromatase inhibitors may not be an option if the patient is intolerant, concerns over bone density or patient declines therapy.
Copyright 2016 The University of Texas MD Anderson Cancer Center
Department of Clinical Effectiveness V14
Approved by Executive Committee of the Medical Staff on 06/28/2016
Breast Cancer – Invasive
Page 12 of 16
This practice algorithm has been specifically developed for MD Anderson using a multidisciplinary approach and taking into consideration circumstances particular to MD Anderson,
including the following: MD Anderson’s specific patient population; MD Anderson’s services and structure; and MD Anderson’s clinical information. Moreover, this algorithm is not
intended to replace the independent medical or professional judgment of physicians or other health care providers. This algorithm should not be used to treat pregnant women.
SUGGESTED READINGS
Albain KS, Barlow WE, Ravdin PM, et al. (2009). Breast Cancer Intergroup of North America. Adjuvant chemotherapy and timing of tamoxifen in postmenopausal patients with endocrine-responsive, node-positive
breast cancer: a phase 3, open-label, randomised controlled trial. Lancet; 374(9707):2055-63.
Baselga J, Campone M, Piccart M, et al. (2012). Everolimus in postmenopausal hormone-receptor-positive advanced breast cancer. N Engl J Med; 366(6): 520-9.
Baselga J, Cortes J, Kim SB, et al. (2012). CLEOPATRA Study Group. Pertuzumab plus trastuzumab plus docetaxel for metastatic breast cancer. N Engl J Med; 366(2):109-19.
Bear H, Anderson S, Smith R, et al. (2006). Sequential preoperative or postoperative docetaxel added to preoperative doxorubicin plus cyclophosphamide for operable breast cancer: National Surgical Adjuvant Breast
and Bowel Project Protocol B-27. J Clin Oncol; 24(13):2019-27.
Breast. In: Edge SB, Byrd SR, Compton CC, Fritz AG, Greene FL, Trotti A III, eds. AJCC Cancer Staging Manual. 7th ed. New York, NY: Springer; 2010:347-376.
Buchholz TA, Theriault RL, Niland JC, et al. (2006). The use of radiation as a component of breast conservation therapy in National Comprehensive Cancer Network Centers. J Clin Oncol; 24(3):361-9.
Buchholz TA. (2009). Radiation therapy for early-stage breast cancer after breast-conserving surgery. N Engl J Med; 360(1):63-70.
Burstein HJ, Prestrud AA, Seidenfeld J, et al. (2010). American Society of Clinical Oncology clinical practice guideline: Update on adjuvant endocrine therapy for women with hormone receptor-positive breast cancer.
J Clin Oncol; 28(23):3784-3796.
Buzdar A, Ibrahim N, Francis D, et al. (2005). Significantly higher pathologic complete remission rate after neoadjuvant therapy with trastuzumab, paclitaxel, and epirubicin chemotherapy: Results of a randomized trial in
human epidermal growth factor receptor 2-positive operable breast cancer. J Clin Oncol; 23(16):3676-85.
Caudle AS, Gonzalez-Angulo AM, Hunt KK, et al. (2010). Predictors of tumor progression during neoadjuvant chemotherapy in breast cancer. J Clin Oncol; 28(11):1821-8.
Caudle AS, Hunt KK, Kuerer HM, et al. (2011). Multidisciplinary considerations in the implementation of the findings from the American College of Surgeons Oncology Group (ACOSOG) Z0011 study: a practicechanging trial. Ann Surg Oncol; 18(9):2407-12.
Caudle AS & Kuerer HM. (2015). Targeting and limiting surgery for patients with node-positive breast cancer. BMC Med, 13:149.
doi: 10.1186/s12916-015-0385-5.
Caudle AS, Yang WT, Mittendorf EA, Black DM, Hwang R, Hobbs B, Hunt KK, Krishnamurthy S, & Kuerer HM. (2015). Selective surgical localization of axillary lymph nodes containing metastases
in patients with
breast cancer: a prospective feasibility trial. JAMA Surg, 150(2):137-43.
Caudle AS, Yang WT, Krishnamurthy S, Mittendorf EA, Black DM, Gilcrease MZ, Bedrosian Isabelle…& Kuerer H. (2016). Improved axillary evaluation following neoadjuvant therapy for patients
with node-positive
breast cancer using selective evaluation of clipped nodes: implementation of targeted axillary dissection. J Clin Oncol (in press)
Clarke M, Collins R, Darby S, et al. (2005). Effects of radiotherapy and of differences in the extent of surgery for early breast cancer on local recurrence and 15-year survival: an overview of the randomised trials.
Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Lancet; 366(9503):2087-106.
Early Breast Cancer Trialists' Collaborative Group. (2005). Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: An overview of the randomised trials.
Lancet; 365(9472):1687-1717.
EBCTCG (Early Breast Cancer Trialists’ Collaborative Group), McGale P, Taylor C, Correa C, et al. (2014). Effect of radiotherapy after mastectomy and axillary surgery on 10-year recurrence and 20-year breast
cancer mortality: meta-analysis of individual patient data for 8135 women in 22 randomised trials. Lancet; 383(9935):2127-35.
Fearmonti RM, Vicini FA, Pawlik TM, et al. (2007). Integrating partial breast irradiation into surgical practice and clinical trials. Surg Clin North Am; 87(2):485-98.
Fisher B, Bryant J, Wolmark N, et al. (1998). Effect of preoperative chemotherapy on the outcome of women with operable breast cancer. J Clin Oncol; 16(8):2672-85.
Fisher B, Jeong JH, Anderson S, et al. (2002). Twenty-five-year follow-up of a randomized trial comparing radical mastectomy, total mastectomy, and total mastectomy followed by irradiation.
N Engl J Med; 347(8):567-75.
Floyd SR, Buchholz TA, Haffty BG, et al. (2006). Low local recurrence rate without postmastectomy radiation in node-negative breast cancer patients with tumors 5 cm and larger.
Int J Radiat Oncol Biol Phys; 66(2):358-64.
Copyright 2016 The University of Texas MD Anderson Cancer Center
Department of Clinical Effectiveness V14
Approved by Executive Committee of the Medical Staff on 06/28/2016
Breast Cancer – Invasive
Page 13 of 16
This practice algorithm has been specifically developed for MD Anderson using a multidisciplinary approach and taking into consideration circumstances particular to MD Anderson,
including the following: MD Anderson’s specific patient population; MD Anderson’s services and structure; and MD Anderson’s clinical information. Moreover, this algorithm is not
intended to replace the independent medical or professional judgment of physicians or other health care providers. This algorithm should not be used to treat pregnant women.
SUGGESTED READINGS - Continued
Foulkes WD, Smith IE, Reis-Filho JS. (2010). Triple-negative breast cancer. N Engl J Med; 363(20):1938-48.
Gennari A, Stockler M, Puntoni M, et al. (2011). Duration of chemotherapy for metastatic breast cancer: a systematic review and meta-analysis of randomized clinical trials. J Clin Oncol; 29(16):2144-9.
Gianni L, Eiermann W, Semiglazov V, et al. (2010). Neoadjuvant chemotherapy with trastuzumab followed by adjuvant trastuzumab versus neoadjuvant chemotherapy alone, in patients with HER2positive locally advanced breast cancer (the NOAH trial): A randomised controlled superiority trial with a parallel HER2-negative cohort. Lancet; 375(9712):377-84.
Gianni L, Pienkowski T, Im YH, et al. (2012). Efficacy and safety of neoadjuvant pertuzumab and trastuzumab in women with locally advanced, inflammatory, or early HER2-positive breast cancer
(NeoSphere): a randomised multicentre, open-label, phase 2 trial. Lancet Oncol; 13(1):25-32.
Giordano SH, Kuo YF, Freeman JL, et al. (2005). Risk of cardiac death after adjuvant radiotherapy for breast cancer. J Natl Cancer Inst; 97(6):419-24.
Giuliano AE, Hunt KK, Ballman KV, et al. (2011). Axillary dissection vs no axillary dissection in women with invasive breast cancer and sentinel node metastasis: a randomized clinical trial.
JAMA; 305(6):569-75.
Giuliano AE, McCall L, Beitsch P, et al. (2010). Locoregional recurrence after sentinel lymph node dissection with or without axillary dissection in patients with sentinel lymph node metastases: the
American College of Surgeons Oncology Group Z0011 randomized trial. Ann Surg; 252(3):426–33.
Huang EH, Strom EA, Valero V, et al. (2007). Locoregional treatment outcomes for breast cancer patients with ipsilateral supraclavicular metastases at diagnosis.
Int J Radiat Oncol Biol Phys;67(2):490-6.
Hunt KK, Yi M, Mittendorf EA, et al. (2009). Sentinel lymph node surgery after neoadjuvant chemotherapy is accurate and reduces the need for axillary dissection in breast cancer patients.
Ann Surg; 250(4):558-66.
Jeruss J, Mittendorf E, Tucker S, et al. (2008).Combined use of clinical and pathologic staging variables to define outcomes for breast cancer patients treated with neoadjuvant therapy.
J Clin Oncol; 26(2):246-52.
Jones SE, Savin MA, Holmes FA, et al. (2006). Phase III trial comparing doxorubicin plus cyclophosphamide with docetaxel plus cyclophosphamide as adjuvant therapy for operable breast cancer.
J Clin Oncol; 24(34):5381-5387.
Kelly CM, Hortobagyi GN. (2010). Adjuvant chemotherapy in early-stage breast cancer: what, when, and for whom? Surg Oncol Clin N Am; 19(3):649-68.
Krag DN, Anderson SJ, Julian TB, et al. (2010). Sentinel-lymph-node resection compared with conventional axillary-lymph-node dissection in clinically node-negative patients with breast cancer:
overall survival findings from the NSABP B-32 randomised phase 3 trial. Lancet Oncol; 11(10):927-33.
Krag DN, Anderson SJ, Julian TB, et al. (2007). Technical outcomes of sentinel-lymph-node resection and conventional axillary-lymph-node dissection in patients with clinically node-negative breast
cancer: results from the NSABP B-32 randomised phase III trial. Lancet Oncol; 8(10):881-8.
Kuerer H, Sahin A, Hunt K, et al. (1999). Incidence and impact of documented eradication of breast cancer axillary lymph node metastases before surgery in patients treated with neoadjuvant
chemotherapy. Ann Surg; 230(1):72-8.
Kuerer HM, Hunt KK, Newman L, et al. (2000). Neoadjuvant chemotherapy in women with invasive breast carcinoma: conceptual basis and fundamental surgical issues.
J Am Coll Surg; 190(3):350-63.
Kuerer HM, Newman LA, Smith TL, et al. (1999). Clinical course of breast cancer with complete pathologic primary tumor and axillary lymph node response to doxorubicin-based neoadjuvant
chemotherapy. J Clin Oncol; 17(2):460-9.
Copyright 2016 The University of Texas MD Anderson Cancer Center
Department of Clinical Effectiveness V14
Approved by Executive Committee of the Medical Staff on 06/28/2016
Breast Cancer – Invasive
Page 14 of 16
This practice algorithm has been specifically developed for MD Anderson using a multidisciplinary approach and taking into consideration circumstances particular to MD Anderson,
including the following: MD Anderson’s specific patient population; MD Anderson’s services and structure; and MD Anderson’s clinical information. Moreover, this algorithm is not
intended to replace the independent medical or professional judgment of physicians or other health care providers. This algorithm should not be used to treat pregnant women.
SUGGESTED READINGS - Continued
Lucci A, McCall LM, Beitsch PD, et al. (2007). American College of Surgeons Oncology Group. Surgical complications associated with sentinel lymph node dissection (SLND) plus axillary lymph
node dissection compared with SLND alone in the American College of Surgeons Oncology Group trial Z0011. J Clin Oncol; 25(24):3657–63.
Mehta RS, Barlow WE, Albain KS, et al. (2012). Combination anastrozole and fulvestrant in metastatic breast cancer. N Engl J Med; 367(5):435-44.
Mittendorf EA, Buchholz TA, Tucker SL, et al. (2013). Impact of chemotherapy sequencing on local-regional failure risk in breast cancer patients undergoing breast-conserving therapy.
Ann Surg; 257(2):173-9.
National Comprehensive Cancer Network (NCCN). Practice Guidelines in Oncology: Breast Cancer. Version 3.2015.
Paik S, Shak S, Tang G, et al. (2004). A multigene assay to predict recurrence of tamoxifen-treated, node-negative breast cancer. N Eng J Med; 351:2817-26.
Paik S, Tang G, Shak S, et al. (2006). Gene expression and benefit of chemotherapy in women with node-negative, estrogen receptor-positive breast cancer. J Clin Oncol; 24(23):3726-34.
Piccart-Gebhart MJ, Procter M, Leyland-Jones B, et al. (2005). Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer. N Engl J Med; 353(16):1659-1672.
Pritchard KI, Shepherd LE, O’Malley FP, et al. (2006). HER2 and responsiveness of breast cancer to adjuvant chemotherapy. N Engl J Med; 354(20):2103-11.
Prudence A, Francis MD, Meredith, MR, et al (2015). Adjuvant ovarian suppression in premenopausal breast cancer. N England J Med; 372:436-446. PMID: 25495490
doi: 10.1056/NEJMoa1412379. Epub 2014 Dec 11.
Romond EH, Perez EA, Bryant J, et al. (2005). Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer. N Engl J Med; 353(16):1673-1684.
Schneeweiss A, Chia S, Hickish T, et al. (2013) Pertuzumab plus trastuzumab in combination with standard neoadjuvant anthracycline-containing and anthracycline-free chemotherapy regimens in
patients with HER2-positive early breast cancer: a randomized phase II cardiac safety study (TRYPHAENA). Ann Oncol; 24(9):2278-84.
Smith BD, Arthur DW, Buchholz TA, et al. (2009). Accelerated partial breast irradiation consensus statement from the American Society for Radiation Oncology (ASTRO).
J Am Coll Surg; 209(2):269-77.
Smith BD, Haffty BG, Buchholz TA, et al. (2006). Effectiveness of radiation therapy in older women with ductal carcinoma in situ. J Natl Cancer Inst; 98(18):1302-10.
Smith BD, Haffty BG, Smith GL, et al. (2008). Use of postmastectomy radiotherapy in older women. Int J Radiat Oncol Biol Phys; 71(1):98-106.
Sparano JA, Wang M, Martino S, et al. (2008). Weekly paclitaxel in the adjuvant treatment of breast cancer. N Engl J Med; 358(16):1663-71.
Symmans W, Peintinger F, Hatzis C, et al. (2007). Measurement of residual breast cancer burden to predict survival after neoadjuvant chemotherapy. J Clin Oncol; 25(28):4414-22.
Tolaney SM, Barry WT, Dang CT, et al. (2015). Adjuvant paclitaxel and trastuzumab for node-negative, HER2-positive breast cancer. N Engl J Med; 372(2):134-41.
Veronesi U, Viale G, Paganelli G, et al. (2010). Sentinel lymph node biopsy in breast cancer: ten-year results of a randomized controlled study. Ann Surg; 251(4):595–600.
Vicini F, Beitsch P, Quiet C, et al. (2011). Five-year analysis of treatment efficacy and cosmesis by the American Society of Breast Surgeons MammoSite Breast Brachytherapy Registry Trial in
patients treated with accelerated partial breast irradiation. Int J Radiat Oncol Biol Phys; 79(3):808-17.
Yamauchi H, Woodward WA, Valero V, et al. (2012). Inflammatory breast cancer: What we know and what we need to learn. Oncologist; 17(7):891-9.
Copyright 2016 The University of Texas MD Anderson Cancer Center
Department of Clinical Effectiveness V14
Approved by Executive Committee of the Medical Staff on 06/28/2016
Breast Cancer – Invasive
Page 15 of 16
This practice algorithm has been specifically developed for MD Anderson using a multidisciplinary approach and taking into consideration circumstances particular to MD Anderson,
including the following: MD Anderson’s specific patient population; MD Anderson’s services and structure; and MD Anderson’s clinical information. Moreover, this algorithm is not
intended to replace the independent medical or professional judgment of physicians or other health care providers. This algorithm should not be used to treat pregnant women.
SUGGESTED READINGS – Chemotherapy Regimens for Metastatic Breast Cancer and in Combination with Transtuzumab
Burstein HJ, Kuter I, Campos SM, et al. (2001). Clinical activity of trastuzumab and vinorelbine in women with HER2-overexpressing metastatic breast cancer. J Clin Oncol,19,2722-30.
Cobleigh MA, Vogel CL, Tripathy D, et al. (1999). Multinational Study of the Efficacy and Safety of Humanized Anti-HER2 Monoclonal Antibody in Women Who Have HER2- Overexpressing Metastatic Breast Cancer That Has
Progressed After Chemotherapy for Metastatic Disease. J Clin Oncol, 17,2639-48.
Esteva FJ, Valero V, Booser D, et al. (2002). Phase II Study of Weekly Docetaxel and Trastuzumab for Patients With HER2-Overexpressing Metastatic Breast Cancer. J Clin Oncol, 20,1800-1808.
Geyer CE, Forster J, Lindquist D, et al. (2006). Lapatinib plus Capecitabine for HER2-Positive Advanced Breast Cancer. NEJM,355,2733-43.
Gradishar WJ, Tjulandin S, Davidson N, et al. (2005). Phase III Trial of Nanoparticle Albumin-Bound Paclitaxel Compared With Polyethylated Castor Oil-Based Paclitaxel in Women With Breast Cancer. J Clin Oncol 23:7794-7803
Leyland-Jones, Gelmon, Ayoub JB, et al. (2003). Pharmacokinetics, Safety, and Efficacy of Trastuzumab Administered Every Three Weeks in Combination with Paclitaxel. J Clin Oncol 21, 3965-3971.
O’Brien, M. E., Wigler, N., Inbar M, et al. (2004). Reduced Cardiotoxicity and Comparable Efficacy in a Phase lll Trial of Pegylated Liposomal Doxorubicin HC1 (CAELYX/Doxil) vs. Conventional Doxorubicin for First-Line
Treatment of Metastatic Breast Cancer. Ann Oncol, 15(3), 440-9.
Perez E. (2004). Carboplatin in combination therapy for metastatic breast cancer. The Oncologist, 9,518-527.
Slamon DJ, Leyland-Jones B, Shak S, et al. (2001). Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med, 344,783-92.
Copyright 2016 The University of Texas MD Anderson Cancer Center
Department of Clinical Effectiveness V14
Approved by Executive Committee of the Medical Staff on 06/28/2016
Breast Cancer – Invasive
Page 16 of 16
This practice algorithm has been specifically developed for MD Anderson using a multidisciplinary approach and taking into consideration circumstances particular to MD Anderson,
including the following: MD Anderson’s specific patient population; MD Anderson’s services and structure; and MD Anderson’s clinical information. Moreover, this algorithm is not
intended to replace the independent medical or professional judgment of physicians or other health care providers. This algorithm should not be used to treat pregnant women.
DEVELOPMENT CREDITS
This practice consensus algorithm is based on majority expert opinion of the Breast Center Faculty at the University of Texas MD Anderson Cancer Center. It was developed using a
multidisciplinary approach that included input from the following breast multidisciplinary team members.
Sausan Abouharb, MD
Beatriz Adrada, MD
Catherine Akay, MD
Constance Albarracin,MD
Frederick Ames, MD
Elsa Arribas, MD
Banu K. Arun, MD
Carlos Barcenas, MD
Robert C. Bast, MD
Gildy Babiera, MD
Isabelle Bedrosian, MD
Daniel J. Booser, MD
Shon Black, MD
Abenna Brewster, MD
Powel Brown, MD
Thomas Buchholz, MD
Aman U. Buzdar, MD
Abigail Caudle, MD
Mariana Chavez-Mac Gregor, MD
Hui Chen, MD
Alejandro Contreras, MD
Sarah DeSnyder, MD
Mark Dryden, MD
Mary Edgerton, MD
Barry Feig, MD
Bruno Fornage, MD
Michael Gilcrease, MD
Sharon Giordano, MD
Tamara Haygood, MD
Karen Hoffman, MD
Gabriel N. Hortobagyi, MD
Kelly K. Hunt, MD Ŧ
Lei Huo, MD
Rosa Hwang, MD
Nuhad K. Ibrahim, MD
Meghan Karuturi, MD
Kimberly Koenig, MD
Savitri Krishnamurthy, MD
Henry M. Kuerer, MD, PhD
Deanna Lane, MD
Huong Le-Petross, MD
Jennifer Litton, MD Ŧ
Anthony Lucci, MD
Funda Meric-Bermstam, MD
Lavinia Middleton, MD
Elizabeth Mittendorf, MD, PhD
Stacy Moulder, MD
James L. Murray,III, MD
Rashmi Murthy, MD
George Perkins, MD
Erika Resetkova, MD
Merrick I. Ross, MD
Aysegul A. Sahin, MD
Lumarie Santiago, MD
Simona Shaitelman, MD
Benjamin Smith, MD
Nour Sneige, MD
Tanya Moseley, MD
Michael Stauder, MD
Eric Strom, MD
Fraser W. Symmans, MD
Welela Tereffe, MD Ŧ
Mediget Teshome, MD
Alastair Thompson, MD
Debasish Tripathy, MD
Naoto T. Ueno, MD, PhD
Vicente Valero, MD
Ronald Walters, MD
Gary Whitman, MD
Wendy Woodward, MD
Yun Wu, MD
Wei Yang, MD
Amy Zhang, MD
ŦCore Development Team
Copyright 2016 The University of Texas MD Anderson Cancer Center
Department of Clinical Effectiveness V14
Approved by Executive Committee of the Medical Staff on 06/28/2016