Study Design and Patients
PD, death, neoadjuvant breast cancer
DISEASE, RENAL IMPAIRMENT, RECURRENCE, BREAST CANCER
NEOTALA was an open-label, multicenter, single-arm, phase II study initially designed to enroll 122 patients (Study design. Abbreviations: BC, breast cancer; EFS, event-free survival; gIn keeping with the initial pilot study, the prescribed treatment phase was 24 weeks (6 cycles of 4 weeks). Patients were administered a starting dose of oral talazoparib 1 mg/day, or 0.75 mg/day for moderate renal impairment. Treatment was followed by breast surgery within 6 weeks of completing neoadjuvant treatment, and pCR was assessed by both independent central review (ICR) and investigator. Standard-of-care treatment could be initiated following progressive disease (PD) with investigator’s choice of therapy. Investigator’s choice of systemic therapy could also be initiated post-surgery. The safety follow-up period was 28 days after the last dose of talazoparib or initiation of a new anticancer therapy. Long-term follow-up of event-free survival (EFS), defined as the time from surgery date to first documentation of local or distant recurrence, death, or initiation of antineoplastic therapy before documentation of first relapse, assessed starting after surgery, and overall survival (OS), assessed from first dose, was planned for 3 years, and collected every 12 weeks by telephone.Because of a strategic change in the development program by the sponsor, not related to safety or efficacy concerns for talazoparib in the neoadjuvant breast cancer setting, the study was closed on September 23, 2020, after all patients completed the safety follow-up, and therefore, the long-term EFS and OS endpoints were not met or evaluated.The study protocol was reviewed and approved by an institutional review board and ethics committee and research ethics board, and conducted under the International Ethical Guidelines for Biomedical Research Involving Human Patients, the International Council for Harmonisation Guideline for Good Clinical Practice, the Declaration of Helsinki, and other applicable national and local regulations. Written evidence of informed consent was required before patients could be enrolled into the study.