This phase I trial studies the side effects and best dose of rucaparib camsylate when given together with radiation therapy in treating patients with triple negative breast cancer or hormone receptor positive breast cancer. Rucaparib camsylate is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving rucaparib camsylate and radiation therapy may work better in treating patients with triple negative breast cancer or hormone receptor positive breast cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03542175.
PRIMARY OBJECTIVE:
I. To determine the maximum tolerated dose of rucaparib camsylate (rucaparib) that can be administered concurrently with standard doses of radiotherapy to the breast/chest wall +/- regional nodes.
SECONDARY OBJECTIVES:
I. To describe the nature of toxicity that develops when rucaparib is administered concurrently with radiation therapy (RT).
II. To assess locoregional relapse and distant relapse.
III. To evaluate biomarkers (homologous recombination deficiency [HRD] status) correlated with locoregional relapse following rucaparib administered concurrently with RT.
IV. To evaluate the presence of tumor infiltrating lymphocytes (TILs) and correlate this with locoregional relapse.
V. To assess patient reported satisfaction and quality of life with treatment using the Breast Cancer Treatment Outcomes Scale (BCTOS).
VI. To determine the rate of poor cosmetic outcomes from both provider and patient perspectives up to 2 years after rucaparib + RT using the RTOG (Radiation Therapy Oncology Group) cosmesis scale and digital images.
OUTLINE: This is a dose-escalation study of rucaparib camsylate.
Patients undergo radiation therapy once daily (QD) 5 days per week and receive rucaparib camsylate orally (PO) twice daily (BID) beginning the evening after radiation therapy. Treatment continues for 6 weeks (or 5 weeks for patients not treated with a boost) in the absence of disease progression or unacceptable toxicity. Patients then receive rucaparib camsylate PO BID for 4 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3-6 months for 2 years.
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorAtif Jalees Khan