Download MD Anderson Cancer Center Clinical Trials for Breast Cancer

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MD Anderson Cancer Center Clinical Trials
for Breast Cancer
To refer online: https://my.mdanderson.org
To refer a patient, call the Breast Center: 713-792-2360
To discuss breast cancer clinical trials, call Jie Willey, administrative director, Protocol Research: 713-792-3965
Ductal Carcinoma In Situ Pre-Operative
2008-0086 (P.I. Powel Brown, M.D.): Multicenter NCI
Division of Cancer Prevention Neoadjuvant Trial of
Lapatinib for the Treatment of Women with DCIS
Breast Cancer.
CALGB-40903 (P.I. Isabelle Bedrosian, M.D.): Phase
II Study of Neoadjuvant Letrozole for
Postmenopausal Women with Estrogen Receptor
Positive Ductal Carcinoma In Situ.
Pregnant Patients
ID01-193 (P.I. Jennifer Litton, M.D.): Multimodality
Treatment of Primary Breast Cancer During
Pregnancy.
Neoadjuvant Therapy-Untreated
2010-0145 (P.I. Stacy Moulder, M.D.): Investigation of
Serial Studies to Predict Therapeutic Response
with Imaging and Molecular Analysis.
2012-0167 (P.I. Ricardo Alvarez, M.D.): Randomized
Phase II Neoadjuvant Study of Sequential Eribulin
Followed by FAC/FEC-Regimen Compared to
Sequential Paclitaxel Followed by FAC/FECRegimen in Women with Early Stage Breast
Cancer.
Adjuvant Therapy
2010-0559 (P.I. Benjamin Smith, M.D.): Randomized
Trial of Hypofractionated Whole Breast Irradiation
Versus Conventionally Fractionated Whole
Breast Irradiation for Ductal Carcinoma in Situ
and Early Invasive Breast Cancer.
2009-0818 (P.I. Eric A. Strom, M.D.): Assessing the
Cosmesis and Toxicity of Partial Breast
Irradiation Using Proton Beam Irradiation.
2012-0399 (P.I. Wendy A. Woodward, M.D.): A
Phase I Study of Veliparib Administered
Concurrently with Chest Wall and Nodal
Radiation Therapy in Patients with Inflammatory
or Loco-regionally Recurrent Breast Cancer.
SWOGS1007 (P.I. Gabriel Hortobagyi, M.D.): Phase
III, Randomized Clinical Trial of Standard Adjuvant
Endocrine Therapy +/- Chemotherapy in Patients
with 1-3 Positive Nodes, Hormone ReceptorPositive and HER-2 Negative Breast Cancer with
Recurrence Score (RS) of 25 or Less.
2011-0595 (P.I. Elizabeth A. Mittendorf, M.D.):
Prevention of Recurrence in Early-Stage, NodePositive Breast Cancer with Low to Intermediate
HER2 Expression with NeuVax Treatment.
2009-0892 (P.I. Elizabeth A. Mittendorf, M.D.): Phase
Ib Trial of Combination Immunotherapy with
HER2/neu Peptide GP2+GM-CSF Vaccine and
Trastuzumab in Breast Cancer Patients.
2007-0125 (P.I. Elizabeth A. Mittendorf, M.D.):
Prospective, Randomized, Single-Blinded, MultiCenter Phase II Trial of the HER2/neu Peptide
GP2 + GM-CSF Vaccine versus GM-CSF Alone in
HLA-A2+ OR the Modified HER2/neu Peptide
AE37 GM-CSF Vaccine versus GM-CSF Alone in
HLA-A2+ Node-Positive and High-Risk NodeNegative Breast Cancer Patients to Prevent
Recurrence.
Inflammatory Breast Cancer (IBC) Neoadjuvant-Untreated
2008-0372 (P.I. Naoto Ueno, M.D.): Phase II Study of
Panitumumab, Nab-paclitaxel and Carboplatin for
Patients with Primary Inflammatory Breast Cancer
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(IBC) without HER2 Overexpression.
2006-1072 (P.I. Naoto Ueno, M.D.): Inflammatory
Breast Cancer (IBC) Registry.
2012-0142 (P.I. Naoto Ueno, M.D.) A Phase I,
Multicenter, Open-label, Dose Escalation Study of
ASP3026 in Subjects with Advanced Malignancies
(Including Patients with IBC).
2012-0142 ( P.I. Naoto Ueno, M.D.): A Phase I,
Multicenter, Open-label, Dose Escalation Study
of ASP3026 in Subjects with Advanced
Malignancies (Including Patients with IBC).
NSABPFB-7 (P.I. Vicente Valero, M.D.): Phase II
Randomized Clinical Trial Evaluating Neoadjuvant
Therapy Regimens with Weekly Paclitaxel plus
Neratinib or Trastuzumab or Neratinib and
Trastuzumab Followed by Doxorubicin and
Cyclophosphamide with Postoperative
Trastuzumab in Women with Locally Advanced
HER2 Positive Breast Cancer.
Alteration of the PIK3CA Gene.
2010-0842 (P.I. Naoto Ueno, M.D.): Phase I/II Study of
Entinostat and Lapatinib in Patients with HER2Positive Metastatic Breast Cancer in Whom
Trastuzumab Has Failed.
2011-1009 (P.I. George Blumenschein, M.D.): An
Open-Label Phase I Dose Escalation Study to
Evaluate the Safety, Tolerability,
Pharmacokinetics, Pharmacodynamics and
Maximum Tolerated Dose of the Anti-mesothelin
Antibody Drug Conjugate BAY 94-9343 in
Subjects with Advanced Solid Tumors.
2012-0229 (P.I. Stacy Moulder, M.D.): Phase I Study
with Dose Expansion of Dinaciclib (SCH 727965)
in Combination with Epirubicin in Patients with
Metastatic Triple Negative Breast Cancer.
Metastatic Inflammatory Breast Cancer
2010-0224 (P.I. Banu Arun, M.D.): Randomized Phase
II Trial of Single Agent ABT-888 with Postprogression Therapy of ABT-888 in Combination
with Carboplatin in Patients with Stage 4 BRCAAssociated Breast Cancer.
2010-0296 (P.I. Ricardo Alvarez, M.D.): Phase II Study
of TKI258 (Dovitinib Lactate) as Salvage Therapy
in Patients with Stage 4 HER2-negative IBC and
Local or Distant Relapse.
2010-0242 (P.I. Funda Meric-Bernstam, M.D.): Phase
II Trial of Akt Inhibitor MK-2206 in Patients with
Advanced Breast Cancer who Have Tumors with a
PIK3CA Mutation and/or PTEN Loss.
First or Second Line Therapy
2011-1239 (P.I. Vicente Valero, M.D.): Circulating
FGF21 Levels and Efficacy of Exemestane,
Everolimus and Metformin in Postmenopausal
Women with Hormone Receptor Positive
Metastatic Breast Cancer and BMI 25.
2011-1135 (P.I. Ricardo Alvarez, M.D.): Phase II,
Double-Blind, Placebo-Controlled, Randomized
Study of GDC-0941 or GDC 0980 with Fulvestrant
Versus Fulvestrant in Advanced or Metastatic
Breast Cancer in Patients Resistant to Aromatase
Inhibitor Therapy.
Third or Any Line
2010-0449 (P.I. Stacy Moulder, M.D.): Phase IA,
Multicenter, Open-Label Dose Escalation Study of
Oral BYL719, in Adult Patients with Advanced
Solid Malignancies, Whose Tumors Have An
2011-0327 (P.I. George Blumenschein, M.D. and Ana
M. Gonzalez-Angulo, M.D.): Phase Ib trial of the
Combination of PI3K Inhibitor BAY 80-6946 and
Allosteric-MEK Inhibitor BAY 86-9766 in Subjects
with Advanced Cancer.
Bone Metastasis
2008-0319 (P.I. Eric Strom, M.D.): Aggressive Local
Therapy for Limited Bone-Only Metastasis to
Improve Progression-Free Survival in Breast
Cancer Patient.