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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 Patient (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 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, MD

Pfizer B2151009: Phase 1b Study To Assess The Safety, Tolerability, And Clinical Activity Of Gedatolisib In Combination With Palbociclib And Either Letrozole Or Fulvestrant In Women With Metastatic Or Locally Advanced/Recurrent Breast Cancer (Mbc)

The purpose of this research study is to learn about the effects of the study drug, gedatolisib, when given in combination with the typical dose of other drugs to treat breast cancer and to find the best dose of gedatolisib in combination with these drugs. The study is made up of two parts. In the first part (called the dose escalation phase), patients will be treated with different dose levels of gedatolisib in combination with palbociclib/letrozole or palbociclib/fulvestrant. This is done in order to determine the maximum tolerated dose or MTD of gedatolisib that will be used in the second part of the study.

Principal Investigator: Shou-Ching Tang, MD

 

Merrimack MM-121-02-02-10 SHERBOC:  A Double-blind, Placebo-controlled, Phase 2 trial of Seribantumab Plus Fulvestrant in Postmenopausal Women with Hormone  Receptor-positive, Heregulin Positive (HRG+), HER2 Negative Metastatic Breast Cancer Whose Disease Progressed After Prior Systemic Therapy

This study is for patients with advanced or metastatic hormone receptor positive breast cancer that has recurred or progressed after at least one previous treatment for metastatic disease including a CDK inhibitor. 

The main purpose of this study is to learn whether cancer cell growth (disease progression) is delayed in people taking seribantumab and fulvestrant for the treatment of heregulin positive, hormone receptor positive metastatic breast cancer.  In order to be enrolled in the study drug dosing portion of this study, you must provide one tissue sample of your tumor to see if your tumor has, or “is positive for” the biomarker heregulin.  If the biomarker test shows that your tumor is positive for heregulin, you may be eligible to participate in the study.

Seribantumab is an investigational (research) drug called an anti-ErbB3 human monoclonal antibody.  In this study, seribantumab or a placebo (like sugar water) will be used in combination with an FDA approved drug called fulvestrant (Faslodex®). Fulvestrant is a common drug for the treatment of hormone receptor positive metastatic breast cancer. Seribantumab has not been tested in combination with fulvestrant before this study. This combination is considered investigational.

Principal Investigator:  Shou-Ching Tang, 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, MD

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, MD