Breast
Any Stage:
IRB #H-28718/SWOG #S0715: A Randomized Placebo-controlled Trial of Acetyl-L-Carnitine (ALC) For the Prevention of Taxane Induced Neuropathy, Phase III (pending)
IRB #H-26576: Understanding Mothers’ and their Adolescent Children’s Responses to Breast Cancer
DCIS:
NSABP #B-43/IRB #2008-040C: A Phase III Clinical Trial Comparing Trastuzumab Given Concurrently with Radiation Therapy and Radiation Therapy Alone for Women with HER2-Positive Ductal Carcinoma In Situ Resected by Lumpectomy
Early Invasive:
IRB #2006-029C/CTSU #ECOG PACCT-1: Program for the Assessment of Clinical Cancer Tests (PACCT-1): Trial Assigning Individualized Options for Treatment: The TAILORx Trial
IRB #2005-016C/NSABP #B-39: A Randomized Phase III Study of Conventional Whole Breast Irradiation (WBI) Versus Partial Breast Irradiation (PBI) for Women with Stage 0, I, or II Breast Cancer (Partial Closure)
Neoadjuvant:
IRB #2006-028C/ACOSOG #Z1031 : Rand Ph III Trial Comparing 16-18 Weeks of Neoadjuvant Exemestane (25mg), Letrozole (2.5mg), or Anastrozole (1mg) in Postmenopausal Women with Clinical Stage II & III ER(+) Br Ca (temp closure 8/15/09)
IRB #H-26580/NSABP #B-41: Randomized Phase III Trial of Neoadjuvant Treatment for Patients with Palpable & Operable HER2(+) Breast Cancer Comparing the Combination of Trastuzumab plus Lapatinib to Trastuzumab and to Lapatinib Administration with Weekly Paclitaxel Following AC Accompanied by Correlative Science Studies to Identify Predictors of Pathologic CR
Adjuvant:
IRB #2008-050C/CTSU #E5103: A Double-Blind Phase III Trial of Doxorubicin and Cyclophosphamide followed by Paclitaxel with Bevacizumab or Placebo in Patients with Lymph Node Positive and High Risk Lymph Node Negative Breast Cancer (temporary closure)
If node (-) must have @ least 1 of the following: ER (-) > 1 cm OR ER (+) tumor > 5 cm OR ER (+) > 1cm but 11
Adjuvant Hormone Receptor Negative:
IRB #H-34112/SWOG #S0230: Phase III Trial of LHRH Analog Administration During Chemotherapy to Reduce Ovarian Failure Following Chemotherapy In Early Stage HR (-) Breast Cancer
Adjuvant Postmenopausal Hormone Receptor Positive :
IRB #2006-055C/NSABP #B-42: A Clinical Trial to Determine the Efficacy of Five Years of Letrozole Compared to Placebo in Patients Completing Five Years of Hormonal Therapy Consisting of an Aromatase Inhibitor (AI) or Tamoxifen Followed by an AI in Prolonging Disease-Free Survival in Postmenopausal Women with Hormone Receptor Positive Breast Cancer
Advanced or Metastatic:
WIRB #2008-1942/Genentech: CLEOPATRA: A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Pertuzumab + Trastuzumab + Docetaxel vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated Her2-Positive Metastatic Breast Cancer 0 prior metastatic treatments (Her 2 neu positive)
WIRB #2009-0449/Genentech: EMILA: A Randomized, Multicenter, Phase III Open-Label Study of the Efficacy and Safety of Trastuzumab-MCC-DM1 vs. Capecitabine plus Lapatinib in Patients with Her2-Positive Locally Advanced or Metastatic Breast Cancer who have Received Prior Trastuzumab-Based Therapy 1 prior metastatic treatment (Her 2 neu positive)
IRB #H-26413/SWOG #S0622:Phase II Studies of Two Different Schedules of Dasatinib (NSC-732517) in Bone-Metastasis Predominant Metastatic Breast Cancer
0 or 1 prior metastatic treatment
ACORN #AC01B07 / WIRB #20070932: A Double-Blind, Randomized Phase 2b Study of Sorafenib Compared to Placebo when Administered in Combination with Gemcitabine for Patients with Locally Advanced or Metastatic Breast Cancer that has Progressed During or After Bevacizumab Therapy
0 or 1 prior metastatic treatment
CTSU #C40502/CIRB #2008-052C: A Randomized Phase III Trial of Weekly Paclitaxel Compared to Weekly Nanoparticle Albumin Bound Nab-Paclitaxel or Ixabepilone Combined with Bevacizumab as First-Line Therapy for Locally Recurrent or Metastatic Breast Cancer
Screening:
IRB #H-27136: Impact of Dedicated Breast PET Imaging vs. Conventional Two-View Digital Mammography on Recall Rates and Cancer Detection as a Screening Examination in Underserved Women (Click IRB number for information and contacts)
