An ongoing research program, led by Edith Mitchell, M.D., FACP, Clinical Professor of Medicine and Clinical Oncology at the Kimmel Cancer Center at Jefferson and Hallgeir Rui, M.D., Ph.D., Professor of Cancer Biology, has initiated a new clinical trial at the Kimmel Cancer Center at Thomas Jefferson University that offers a more customized and personalized approach to the treatment of triple-negative breast cancer. The trial, with lead investigators Drs. Tiffany Avery in the Department of Medical Oncology and Adam Berger in the Department of Surgery, offers treatment in the form of chemotherapy paired with a supplemental medication called a “Parp Inhibitor” and is designed to target the breast cancer cells to increase response to treatment and decrease the risk of recurrence. Researchers will conduct a randomized two-arm trial in 12-week cycles by administering different types of medicines in addition to chemotherapy.
Triple-negative breast cancer cells lack estrogen receptors and progesterone receptors, and do not have an excess of the HER2 protein on their surfaces. This type of breast cancer diagnosis is more prevalent in younger women and in African-American women. Triple-negative breast cancers tend to grow faster and more aggressively and spread to other parts of the body more quicker than most other types of breast cancer. Drs. Mitchell and Rui and their team of researchers are hoping to increase the efficiency and effectiveness of treatment for triple-negative breast cancer through this clinical trial.
Clinical Trial Details:
An adaptive randomized Phase II Trial to determine pathologic complete response with the addition of carboplatin with and without veliparib to standard chemotherapy in the neoadjuvant treatment of triple-negative breast cancer
Study Design: This is a randomized two-arm trial for the neoadjuvant treatment of triple breast cancer patients. The two arms for the trial are as follows:
1. Paclitaxel and carboplatin (12 weekly cycles) with growth factor support followed by doxorubicin and cyclophosphamide (4 cycles every 3 weeks) with growth factor support.
2. Veliparib + paclitaxel + carboplatin (12 weekly cycles) with growth factor support fol
lowed by doxorubicin and cyclophosphamide (4 cycles every 3 weeks) with growth factor support.
The primary objective of the study is to compare the pathologic complete response in patients with triple negative breast cancer treated with paclitaxel and carboplatin or paclitaxel, carboplatin, and veliparib in addition to standard
chemotherapy (adriamycin and cyclophosphamide).
Key Eligibility Criteria:
1. Histologically confirmed adenocarcinoma of the breast with the following markers: Estrogen receptor negative (<1%), progesterone receptor negative (<1%), and Her-2/neu negative (0, 1+ on IHC te
sting or 2+ and FISH ratio < 1.8) or adenocarcinoma identified as basal-like subtype on molecular profiling.
2. Clinical stage IIA, IIB or stage IIIA, IIIB, or IIIC breast cancer with no prior treatment for this tumor.
3. ECOG Performance Status of 0 or 1.
If you think you may be a potential candidate for this clinical study, please contact the study coordinator, Melisa Mordenti, at 215-955-8979.
Click on the video below for more details on this clinical trial.