Breastlink Research Group Clinical Trial Portfolio February 2011

DCIS

NSABP B-43 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

Neo-Adjuvant

ACOSOG Z1031 A Randomized Phase III Trial Comparing 16 to 18 Weeks of Neoadjuvant Exemestane, Letrozole, or Anastrozole in Postmenpausal Women with Clinical Stage II and III Estrogen Receptor Positive Breast Cancer

NSABP B-41 A Randomized Phase III Trial of Neoadjuvant Therapy for Patients with Palpable and Operable HER2-Positive Breast Cancer Comparing the Combination of Trastuzumab Plus Lapatinib to Trastuzumab and to Lapatinib Administered with Weekly Paclitaxel Following AC Accompanied by Correlative Science Studies to Identify Predictors of Pathologic Complete Response

NSABP B-47 A Randomized Phase III Trial of Adjuvant Therapy Comparing Chemotherapy Alone (Six Cycles  of of Docetaxel Plus Cyclophosphamide or Four Cycles of Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel) to Chemotherapy Plus Trastuzumab in Women with Node-Positive or High-Risk Node-Negative HER2-Low Invasive Breast Cancer

SWOG S0800 Randomized Phase II Trial of Weekly Nanoparticle Albumin Bound Paclitaxel (NAB-Paclitaxel) (NSC-736631) with or without Bevacizumab, Either Preceded by or Followed by Q 2 Week Doxorubicin (A) and Cyclophosphamide (C) plus Pegfligrastim (Peg-G) as Neoadjuvant Therapy for Inflammatory and Locally advanced Her2/NEU Negative Breast Cancer

CALGB 40603 Randomized Phase II 2 x 2 Factorial Trial of the Addition of Carboplatin +/- Bevacizumab to Neoadjuvant Paclitaxel Followed by Dose-Dense AC in Hormone Receptor-Poor/Her2-Negative Resectable Breast Cancer  

Adjuvant

A Randomized Double Blind Placebo-Controlled Trial of Neratinib (HKI-272) After Trastuzumab in Women with Early-Stage HER-2/neu Overexpressed/Amplified Breast Cancer  

Metastatic

EMILIA A Randomized, Multicenter, Phase III Open-Label Study of the Efficacy and Safety of Trastuzumab-MCC-DM1 Vs. Capecitabine + Lapatinib in Patients with HER2‑Positive Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Trastuzumab‑Based Therapy

MARIANNE A Randomized, 3-Arm, Multicenter, Phase III Study to Evaluate the Efficacy and the Safety of T-DM1Combined with Pertuzumab to T-DM1 Combined with Pertuzumab-Placebo (Blinded for Pertuzumab), versus the Combination of Trastuzumab Plus Taxane, as First Line Treatment in HER2 Positive Progressive or Recurrent Locally Advanced or Metastatic Breast Cancer (mBC)

CDX011-03 A Phase II, Randomized, Multicenter Study of CDX-011 (CR011-vcMMAE) in Patients with Advanced GPNMB-Expressing Breast Cancer

2450-US-002 A Phase I/II Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of KW-2450 in Combination with Lapatinib and Letrozole in Subjects with Advanced or Metastatic Breast Cancer whose Tumors Overexpress HER2  

Surgical

PT-304 Prediction of Response to Neoadjuvant Chemotherapy in Women with Operable Breast Cancer

American Breast Laser Ablation Therapy Evaluation (ABLATE)  

Correlative

A Registry of the Target Now® Test Results (Biomarker Expression Patterns) for Evaluation of Correlation with Clinical Outcomes for Cancer Patients  

Quality of Life

SWOG S0230 Phase III Trial of LHRH Analog Administration During Chemotherapy to Reduce Ovarian Failure Following Chemotherapy in Early Stage, Hormone-Receptor Negative Breast Cancer

SWOG S0702 A Prospective Observational Multicenter Cohort Study to Assess the Incidence of Osteonecrosis of the Jaw (ONJ) in Cancer Patients with Bone Metastases Starting on Zoledronic Acid Treatment

Effects of Pharmacological Gonadal Suppression on Neural Activity During Emotional Encoding: an fMRI Study My Year After Breast Cancer

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