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Talazoparib

Poly(ADP-ribose) Polymerase Inhibitors

Enzyme Inhibitors

; Talazoparib should be taken orally once daily (ie, continuous daily dosing) at approximately the same time each day (preferably in the morning). Daily dosing of talazoparib can be interrupted for recovery from toxicity for up to 28 days. For interruptions longer than 28 days, treatment at the same or a reduced dose can be considered based on the discretion of the treating physician.

- Patients will receive Talazoparib 1 mg orally once daily continuously, with or without food. Laboratory values will be monitored every 4 weeks until progression or unacceptable toxicity. Dose modifications should be made based on the observed toxicity

Talazoparib Oral Capsule

Seock-Ah Im, MD, PhD

Yuri Park, RN

Seock-Ah Im

Kyung-Hun Lee, MD

Dae-Won Lee, MD

Talazoparib has shown clinical efficacy in breast cancer patients with germline BRCA1 or BRCA2 mutations. Beyond BRCA1 and BRCA2 mutations, it is plausible that talazoparib may have activity in patients with homologous recombination defects (HRD).

BRCA 1/2 plays an essential role in homologous recombination repair and breast cancer patients with BRCA 1/2 germline mutation have homologous recombination defects (HRD). Besides BRCA1 or BRCA2 germline mutation, a proportion of breast cancer is characterized as having HRD through germline mutation, somatic mutation, and epigenetic alteration of other homologous recombination repair (HRR) genes (which includes but are not limited to ATM, BARD1, BRIP1, CDK12, CHEK1, CHEK2, FANCL, PALB2, PPP2R2A, RAD51B, RAD51C, RAD51D, and RAD54L) (5). It is speculated that tumor with HRD may have clinical benefit from PARP inhibitor. However, the efficacy of talazoparib in advanced breast cancer with HRD is not known. The primary purpose of the present study is to evaluate the efficacy of talazoparib in breast cancer with HRD.

Talazoparib in Advanced Breast Cancer Patients With Homologous Recombinant Deficiency

Talazoparib in Advanced Breast Cancer Patients With Homologous Recombinant Deficiency: A Phase II Clinical and Exploratory Biomarker Study of Talazoparib

Defined as a complete response (CR) or partial response (PR) on two consecutive assessments, at least 28 days apart, as determined by investigator assessment using RECIST v1.1

Defined as the time from the date of first dose administration to the first occurrence of disease progression, as determined by investigator assessment using RECIST v1.1, or death from any cause, whichever occurs first.

Defined as the time from first occurrence of a documented objective response to disease progression, as determined by investigator assessment using RECIST v1.1 or death from any cause, whichever occurs first

Defined as having received CR or PR of any duration or stable disease (SD) ≥ 3 months per RECIST v1.1;

Defined as the time from the date of first dose administration to death from any cause

Number of participants with treatment-related adverse events will be assessed

Spots Global Cancer Trial Database for talazoparib oral capsule