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1 2 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 4 3 (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.