Download Acronym - SUPREMO trial

COMPATIBLE/ NON-COMPATIBLE TRIALS
MRC SUPREMO TRIAL
(BIG 2-04)
(Selective Use of Postoperative Radiotherapy AftEr MastectOmy)
Acronym
Title
StudyDesign
Compatible
with
SUPREMO
A Phase II Clinical Trial in
Patients with BRCA defective
Tumours (6MP)
Phase II Clinical Trial of 6Mercaptopurine(6MP)and low-dose
Methotrexate In Patients With Known BRCA
Defective Tumours
Interventional
Yes
Abiraterone Acetate in
Advanced or Metastatic Breast
Cancer
A Cancer Research UK Phase I/II Open Label
Study to Evaluate the Activity of Abiraterone
Acetate in Oestrogen (ER) or Androgen
Receptor (AR) Positive Advanced or
Metastatic Breast Carcinoma
Interventional
No
Observational
Yes
Observational
Yes
Observational
Yes
Interventional
Yes
Interventional
Observational
Yes
No
Observational
Yes
Adjuvant chemotherapy in older
women with breast cancer
(AChEW)
AFFECT
An Investigation of Breast
Cancer-Related Lymphoedema
Aphinity
Adjuvant chemotherapy in elderly women with
breast cancer (AChEW): Identifying
perceptions and putative barriers in decisionmaking
Examination of affected tissue of BRCA1
variant carriers
An Investigation of the Pathophysiology of
Breast Cancer-Related Lymphoedema of the
Arm
A prospective, randomized multicenter,
multinational, two-arm comparison of
chemotherapy plus trastuzumab given for a
total of one year versus chemotherapy plus
trastuzumab and pertuzumab given for a total
of one year as adjuvant therapy in patients
with operable HER2-positive primary breast
cancer
BoHFAB (sub-study of AZURE)
Avastin Randomised Trial with neo-adjuvant
chemotherapy for patients with early HER 2
negative breast cancer.
Biology of the normal breast
AZURE: Bone Health In Breast Cancer
Survivors (sub-study)
COPE
Diagnostic and therapeutic insights into breast
cancer from morphological and molecular
profiling of breast tumours in patients with
germline p53 mutations (Li Fraumeni
Syndrome)
Observational
Yes
DETECT
Development of biomarkers to improve
outcomes for breast cancer patients at risk of
bone metastases.
Observational
Yes
Digital breast tomosynthesis in
younger symptomatic women.
Digital breast tomosynthesis (DBT): sensitivity
for cancer and accuracy in assessing extent
of malignant disease in symptomatic women
below 60 with clinical or ultrasound signs
compatible with malignancy.
Interventional
Yes
ARTemis
Biology of the normal breast
SUPREMO compatible/ non-compatible listing
V1.0 May 2012
COMPATIBLE/ NON-COMPATIBLE TRIALS
MRC SUPREMO TRIAL
(BIG 2-04)
(Selective Use of Postoperative Radiotherapy AftEr MastectOmy)
Effect of metformin on breast
cancer metabolism
A phase 2 single arm study to examine the
effects of metformin on cancer metabolism in
patients with early stage breast cancer
receiving neoadjuvant chemotherapy
Effects of aromatase inhibition
on body fat and insulin
sensitivity V1
Interventional
Yes
Assessing the effects of aromatase inhibition
on body fat distribution and insulin sensitivity
in postmenopausal breast cancer patients.
Interventional
These pts are
unlikely to be
eligible
EMBRACE
Epidemiological study of familial breast cancer
Observational
Yes
EPHOS-B
Epigenetic determinants of
breast cancer susceptibility
Effect of Perioperative AntiHER-2 therapy on
Early Breast Cancer Study – Biological
phase
Epigenetic determinants of breast cancer
susceptibility; a genetic association study
Interventional
Yes
Observational
Yes
ePOCS feasibility study
electronic Patient-reported Outcomes from
Cancer Survivors (ePOCS): A feasibility study
Observational
Yes
Evaluation of promoting early
presentation service
development
Evaluation of service development in the NHS
Breast Screening Programme: an intervention
to promote early presentation in older women
with breast cancer
Interventional
Yes
FBCS
Identification and molecular analyses of
families with susceptibility to breast cancer
Observational
Yes
FH02
Mammographic surveillance in women aged
35-39 at enhanced familial risk of breast
cancer (FH02)
Observational
Yes
Assessment, validation and improvement of
breast cancer risk assessment models in the
Genesis Family History (FH) Clinic, the
University Hospital of South Manchester at
Wythenshawe Hospital
Observational
Yes
Observational
No
Observational
Yes
FHRisk
Gene expression in mammary
gland development and breast
cancer
GLACIER
Gene expression in mammary gland
development and breast cancer
A study to investigate the Genetics of LobulAr
Carcinoma In situ in EuRope
HAMAM
Highly accurate breast cancer diagnosis
through integration of biological knowledge,
novel imaging modalities, and modelling
(HAMAM).
Observational
Yes
IBIS-II DCIS
IBIS-II DCIS: An international multicentre
study of Anastrozole vs Tamoxifen in
Postmenopausal Women with Ductal
Carcinoma in Situ (DCIS)
Interventional
No
IBIS-II Prevention
IBIS-II Prevention: An international multicentre
study of Anastrozole vs Placebo in
Postmenopausal Women at Increased Risk of
Breast Cancer
Interventional
Yes
SUPREMO compatible/ non-compatible listing
V1.0 May 2012
COMPATIBLE/ NON-COMPATIBLE TRIALS
MRC SUPREMO TRIAL
(BIG 2-04)
(Selective Use of Postoperative Radiotherapy AftEr MastectOmy)
ICICLE
A study to Investigate the genetiCs of In situ
Carcinoma of the ductaL subtypE
Observational
Yes
IMPORT HIGH
Randomised trial testing dose escalated
intensity modulated radiotherapy in women
with higher than average local tumour
recurrence risk after breast conservation
surgery and appropriate systemic therapy for
early breast cancer
Interventional
No
LANTERN
A randomised phase II screening trial with
functional imaging and patient reported
toxicity sub-studies comparing LApatiNib plus
capecitabine versus continued Trastuzumab
plus capecitabine after local therapy in
patients with ERb B2 positive metastatic
breast cancer developing braiN metastasis /es
Interventional
No
Management of breast cancer
for women aged 65+ in
Northwest England
Management of breast cancer for women
aged 65+ in Northwest England: The role of
general health, tumour characteristics and
patient preference in treatment decisions
Observational
Yes
Management of breast cancer
for women aged 70+ in Greater
Manchester
Management of breast cancer for women
aged 70+ in Greater Manchester: The role of
patient choice in the surgical treatment
decision
Observational
Yes
MINDACT
Microarray In Node negative and 1 to 3
positive lymph node Disease may Avoid
ChemoTherapy - A prospective, randomised
study comparing the 70-gene expression
signature with common clinical-pathological
criteria in selecting patients for adjuvant
chemotherapy in breast cancer with 0 to 3
positive nodes. (EORTC Protocol 10041 –
BIG 3-04)
Interventional
Yes
MISO BC
Multidetector Computed Tomography to
Improve Surgical Outcomes in Breast Cancer
(MISO-BC): A Randomised Controlled Trial
Interventional
Yes
Multifrequency Bioimpedance in
the Early Detection of
Lymphoedema
Multifrequency Bioimpedance in the Early
Detection of Lymphoedema after Axillary
Surgery
Observational
Yes
NCRN052 - CEREBEL
A Randomized, Multicentre, Open-Label,
Phase III Study of Lapatinib plus Capecitabine
versus Trastuzumab plus Capecitabine in
Patients with Anthracycline- or TaxaneExposed ErbB2-Positive Metastatic Breast
Cancer.
Interventional
No
SUPREMO compatible/ non-compatible listing
V1.0 May 2012
COMPATIBLE/ NON-COMPATIBLE TRIALS
MRC SUPREMO TRIAL
(BIG 2-04)
(Selective Use of Postoperative Radiotherapy AftEr MastectOmy)
NCRN096 PHEREXA trastuzumab and capecitabine
+/- pertuzumab in 2nd line
HER2+ MBC
A multicenter randomized phase II study to
compare the combination trastuzumab and
capecitabine, with or without pertuzumab, in
patients with HER2-positive metastatic breast
cancer that have progressed after one line of
trastuzumab-based therapy in the metastatic
setting (PHEREXA)
Interventional
No
NCRN100 MINT - anastrazole
+/- AZD8931 in endocrine naïve
ER+ve MBC.
A Phase II, Randomised, Double-Blind,
Placebo-Controlled, Multi-Centre Study Of
AZD8931 In Combination With Anastrozole in
Postmenopausal Women With Hormone
Receptor-Positive, Endocrine Therapy-Naive,
Locally-Advanced or Metastatic Breast
Cancer (MINT)
Interventional
No
Interventional
Yes
Interventional
Yes
Interventional
Yes
Interventional
Yes
Interventional
Yes
POETIC
Duration of Trastuzumab with chemotherapy
in women with early stage breast cancer: six
months versus twelve
Trial of Perioperative Endocrine Therapy Individualising Care
QUEST Trial A
A multi-centre randomised trial to assess the
impact of the type of breast reconstruction on
quality of life of women following mastectomy
for early breast cancer
Persephone
REACT- Randomised European
Celecoxib Trial
SWOG S1007
A phase III multicentre double blind
randomised trial of celecoxib versus placebo
in primary breast cancer patients
A phase III, randomized clinical trial of
standard adjuvant endocrine therapy with or
without chemotherapy in patients with one to
three positive nodes, hormone receptor (HR)positive, and HER2-negative breast cancer
with recurrence score (RS) of 25 or less
SUPREMO compatible/ non-compatible listing
V1.0 May 2012