This early phase I trial studies how well rucaparib works in treating patients with stage I-III triple negative breast cancer. Rucaparib is a poly adenosine diphosphate [ADP]-ribose polymerase (PARP) inhibitor. PARPs are proteins that play an important role in the life of a cell and act as a repair crew to help fix broken or damaged deoxyribose nucleic acid strands, allowing the cell to live. However, in cancer cells PARPs can allow the cells to remain alive, grow, and divide. Rucaparib may stop the growth of tumor cells by blocking PARPs needed for cell growth. Giving rucaparib for a short duration may allow doctors to assess changes in the patients' tumor, which can help determine who might benefit from such therapy and potentially immunotherapy in the future.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03911453.
PRIMARY OBJECTIVE:
I. To evaluate change in expression of PD-L1 by immunohistochemistry (IHC) after treatment with single agent PARP inhibitor (PARPi) (rucaparib) for 3 weeks.
SECONDARY AND EXPLORATORY OBJECTIVES:
I. Change in expression of Ki67 by IHC after treatment with PARPi.
II. To evaluate and quantify change in number of tumor-infiltrating lymphocytes.
III. To quantify levels of tumor PARylation in pre- and post-PARPi therapy by IHC.
IV. To evaluate change in expression of PD-L1 pre- and post-PARPi therapy in circulating tumor cells (CTC’s).
V. To evaluate cell free deoxyribonucleic acid (cfDNA) mutational expression (for homologous recombination deficiency [HRD]) and correlate with PD-L1 expression at baseline and change overtime.
OUTLINE:
Patients receive rucaparib camsylate orally (PO) twice daily (BID) for 3 weeks in the absence of disease progression or unacceptable toxicity. After completion of rucaparib treatment, patients undergo definitive surgery, or an additional biopsy (if planning to receive chemotherapy).
After completion of study treatment, patients are followed up for 30 days.
Lead OrganizationBanner University Medical Center - Tucson
Principal InvestigatorPavani Chalasani
