Clinical Trials

Breast Protocols

1.       CALGB 40603:  Randomized Phase II 2x2 Factorial Trial of the Addition of Carboplatin +/- Bevacizumab to Neoadjuvant Weekly Paclitaxel followed by Dose-Dense AC Chemotherapy in Hormone Receptor-Poor/HER2 - Resectable Breast Cancer

The purpose of the study is to see if adding other drugs to standard neoadjuvant chemotherapy can help shrink triple-negative breast cancer faster, and lower the risk of the cancer coming back in other part of the body.

2.      S1007:  A Phase III Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients with 1-3 Positive Nodes Hormone Receptor Positive and Her2 Negative Breast Cancer with RS of 25 or Less

The purpose of this study is to find out if the Oncotype DX® Recurrence Score can help decide whether patients should receive chemotherapy or not.  This study is being done in patients with lower Recurrence Scores (25 or less).

3.       NSABP-B47:  A Randomized Phase III Trial of Adjuvant Therapy Comparing Chemotherapy Alone to Chemo + Trastuzumab (Herceptin) in Women with Node Positive of High Risk Node Negative Her2 Low Invasive Breast Cancer

The main purpose of this study is to learn if adding a targeted therapy, trastuzumab (Herceptin®), to standard treatment with chemotherapy for early stage, HER2-low breast cancer, will prevent breast cancer from returning.

4.       Z1071:  A Phase II Study Evaluating the Role of Sentinel Lymph Node Surgery & Axillary Lymph Node Dissection Following Preoperative Chemotherapy in Women with Node + Breast Cancer

The purpose of this study is to evaluate the role of sentinel lymph node dissection (SLND) surgery and axillary lymph node dissection (ALND) surgery after chemotherapy in patients with breast cancer that has spread to the lymph nodes in the breast area. These are called the axillary (underarm) lymph nodes.

5.       CALGB 40601:  A Randomized Phase III Trial of Paclitaxel Combined with Trastuzumab, Lapatinib, or Both as Neoadjuvant Treatment of HER2 + Primary Breast Cancer

The purpose of this study is to see if combining two anti-HER2 drugs, lapatinib and trastuzumab, with the chemotherapy drug paclitaxel before surgery increases tumor shrinkage in the breast.

6.       N0733:  Randomized Phase II Trial of Capecitabine & Lapatinib with or without IMC-A12 Pts. With HER2 + Breast Cancer Previously Treated with Trastuzumab and an Anthracycline and/or a Taxane

Capecitabine (Xeloda®) plus lapatinib (Tykerb®) is a standard treatment for HER2 positive metastatic breast cancer.  The purpose of this research study is to find out if a new drug, IMC-A12 (also called “cixutumumab”), can make the treatment with capecitabine and lapatinib work better.  The purpose is also to see what effects, both good and bad, IMC-A12 has when combined with this capecitabine plus lapatinib.

7.      S0800:  A Randomized Phase II Trial of Weekly Nab-Paclitaxel With or Without Bevacizumab, Either Preceded by or Followed by Q2 Week Doxorubicin and Cyclophosphamide Plus Pegfilgrastim as Neoadjuvant Therapy for Inflammatory and Locally Advanced Her2/Neu Negative Breast Cancer

The main purpose of this study is to compare two different treatments (or "regimens") for breast cancer prior to surgery to see if one works better against breast cancer than the other.  One treatment includes the experimental drug combination of bevacizumab and nab-paclitaxel followed by doxorubicin, cyclophosphamide, and pegfilgrastim.  The other treatment includes the drug nab-paclitaxel, but without the bevacizumab, and is given either before or after the doxorubicin, cyclophosphamide, and pegfilgrastim.  The other purpose of this study is to compare the type and severity of the side effects of each of these two treatment regimens.

For more information on these protocols or any other research, please contact your physician or our clinical research coordinator, Jessica Gerlach, CCRP at 845-333-1133.