Breast Cancer NSABP 55

Number: NSABP-55

This randomized phase III (Phase III trials are a new treatment that’s worked well in a small number of patients with a this disease) trial studies how well Olaparib works in treating patients with triple-negative breast cancer  that has not spread to another place in the body who have completed definitive local treatment and chemotherapy. A triple negative breast cancer diagnosis means that the tumor is estrogen receptor-negative, progesterone receptor-negative and HER2-negative. When the pathologist looks at you cancer specimen under a microscope, estrogen/progesterone receptors and HER2 oncogenes (a gene that has the potential to cause cancer) are the biomarkers that help your physician diagnose your cancer. The tissue specimen is obtained through biopsy or surgery. Olaparib may stop the growth of tumor cells by blocking specific enzymes needed for the maintenance of deoxyribonucleic acid (DNA) repair. DNA is the hereditary /genetic material within your body that carries your own unique genetic code.  Olaparib may also enhance the DNA damaging effects of chemotherapy.

Who’s eligible: 

• Histologically (tissue microscopically examined) confirmed non-metastatic (cancer that has spread to other places in the body)  primary invasive adenocarcinoma of the breast that is one of the following phenotypes:
• Triple negative breast cancer defined as: ER and PgR negative AND HER2 negative. Patients with triple negative breast cancer are not eligible for anti-HER2 therapy, since there are no positive receptors for the therapy to target.
• ER and/or PgR positive, HER2 negative. When the pathologist looks at you cancer specimen under a microscope, estrogen/progesterone receptors and HER2 oncogenes (a gene that has the potential to cause cancer) are the biomarkers that help your physician diagnose your cancer. The tissue specimen is obtained through biopsy or surgery.
• Documented germline mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function).
• The patient must have completed at least 6 cycles neoadjuvant or adjuvant chemotherapy containing anthracyclines, taxanes or the combination of both. Neoadjuvant chemotherapy is treatment given as a first step to shrink a tumor before the main treatment, which is usually surgery.   Adjuvant chemotherapy is treatment given after surgery, chemotherapy, and/or radiation therapy to lower the chance of the cancer coming back.  Prior platinum as potentially curative treatment for prior cancer (e.g. ovarian) or as adjuvant or neoadjuvant treatment for breast cancer is allowed.
• This study is for participants age 18 and older.

Available at: The Hospital of Central Connecticut, MidState Medical Center, and Hartford Hospital.