Available Trials

Breast Cancer

For more information regarding these studies, contact Cancer Research and Registry at (601) 984-1095.

Neoadjuvant (Before Surgery)

A011202: A RANDOMIZED PHASE III TRIAL COMPARING AXILLARY LYMPH NODE DISSECTION TO AXILLARY RADIATION IN BREAST CANCER PATIENTS (cT1-3 N1) WHO HAVE POSITIVE SENTINEL LYMPH NODE DISEASE AFTER NEOADJUVANT CHEMOTHERAPY

This study is for breast cancer patients whose disease has spread to lymph nodes under the arm and who have already been treated with chemotherapy. The purpose of this study is to examine whether surgery that removes just some lymph nodes from the arm pit followed with radiation therapy (experimental) will be as good as having more of the lymph nodes from the arm pit removed during breast surgery followed with radiation (standard of care). There are two study groups in this study: Arm 1treatment group will have another surgery to remove more lymph nodes from your arm pit (axillary lymph node dissection), and then begin radiation therapy treatments 3 to 12 weeks after that surgery; Arm 2 group will not have any more lymph nodes removed, and will begin radiation therapy treatments 3 to 12 weeks after surgery.

Principal Investigator: Barbara Craft, MD

Breast Cancer with Metastatic Disease

S1416: S1416 Phase II Randomized Placebo-Controlled Trial of Cisplatin with or without ABT-888 (Veliparib) in Metastatic Triple-Negative Breast Cancer and/or BRCA Mutation-Associated Breast Cancer

This randomized phase II study to see how well cisplatin works with or without veliparib in treating patients with stage IV triple-negative breast cancer and/or breast cancer (BRCA) mutation-associated breast cancer. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known if cisplatin is more effective with or without veliparib in treating patients with triple-negative and/or BRCA mutation-associated breast cancer.

Principal Investigator: Barbara Craft, M.D.

NSABP B-55/BIG 6-13: A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Multi-Center Phase III Study to Assess the Efficacy and Safety of Olaparib Versus Placebo as Adjuvant Treatment in Patients with Germline BRCA1/2 Mutations and High Risk HER2 Negative Primary Breast Cancer Who Have Completed Definitive Local Treatment and Neoadjuvant or Adjuvant Chemotherapy

Usually no additional treatment is given after standard therapy is finished unless the cancer comes back. The purpose of this study is to compare giving olaparib after the standard treatment (chemotherapy, surgery, and sometimes radiation therapy) for high-risk HER2 negative primary breast cancer with BRCA 1 or 2 mutations to no olaparib after standard treatment. In this study, participants will get either olaparib or a placebo l(looks like the study drug but contains no medication) after standard treatment. A placebo is used to help determine if the use of olaparib is better than no additional treatment. Olaparib is approved by the Food and Drug Administration (FDA) for use in patients with ovarian cancer who have BRCA gene mutations.

Principal Investigator: Barbara Craft, MD

Adjuvant Studies (After Surgery)

A011401 Randomized Phase III Trial Evaluating the Role of Weight Loss in Adjuvant Treatment of Overweight and Obese Women with Early Breast Cancer

This randomized phase III study to determine whether weight loss in overweight and obese women may prevent breast cancer from coming back (recurrence). Previous studies have found that women who are overweight or obese when their breast cancer is found (diagnosed) have a greater risk of their breast cancer recurring, as compared to women who were thinner when their cancer was diagnosed. This study aims to test whether overweight or obese women who take part in a weight loss program after being diagnosed with breast cancer have a lower rate of cancer recurrence as compared to women who do not take part in the weight loss program. This study will help to show whether weight loss programs should be a part of breast cancer treatment.

Principal Investigator: Barbara Craft, M.D.

NRG-BR003: A Randomized Phase III Trial of Adjuvant Therapy Comparing Doxorubicin plus Cyclophoshamide Followed by Weekly Paclitaxel with or without Carboplatin for Node-Positive or High-Risk Node-Negative Triple-Negative Invasive Breast Cancer

The purpose of this study is to compare the good and bad effects of the chemotherapy drug, carboplatin, given with the usual chemotherapy drugs after surgery, and to compare it to the usual chemotherapy drugs without carboplatin. This study will allow the researchers to know whether giving carboplatin with the usual chemotherapy is better, the same, or worse than just giving the usual chemotherapy. Carboplatin is FDA-approved for the treatment of cancer and is used for the treatment of breast cancer that has spread, but it has not yet been proven useful in earlier stages of breast cancer.

Principal Investigator: Barbara Craft, M.D.

NSABP B-55/BIG 6-13: A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Multi-Center Phase III Study to Assess the Efficacy and Safety of Olaparib Versus Placebo as Adjuvant Treatment in Patients with Germline BRCA1/2 Mutations and High Risk HER2 Negative Primary Breast Cancer Who Have Completed Definitive Local Treatment and Neoadjuvant or Adjuvant Chemotherapy

This study is for the treatment of BRCA1 or BRCA2 mutation in your genes, you have a type of breast cancer that is HER2-negative and is not sensitive to hormone treatment, and you have already received the usual care for your type of breast cancer (chemotherapy, surgery, and if needed, radiation therapy). The purpose of this study is to compare giving olaparib after the standard treatment (chemotherapy, surgery, and sometimes radiation therapy) to no olaparib after standard treatment. In this study, particpants will get either olaparib or a placebo after standard treatment.

Principal Investigator: Barbara Craft, M.D.

Quality of Life

No trials for Quality of Life are being conducted for breast cancer at UMMC/UMHC.