Circulating Tumor DNA Enriched, Genomically Directed Post-neoadjuvant Trial for Patients With Residual Triple Negative Breast Cancer — PERSEVERE  

Breast Cancer Clinical Trial

Official title: A Phase II Circulating Tumor DNA Enriched, Genomically Directed Post-neoadjuvant Trial for Patients With Residual Triple Negative Breast Cancer (PERSEVERE)

Status Recruiting

Clinical Trial Summary

This is a 3-arm study stratified by plasma ctDNA. Patients with residual TNBC disease after pre-operative therapy will be assigned to 1 of 3 Arms based on plasma ctDNA positivity and genomic marker(s).

Clinical Trial Description

Participants that are plasma ctDNA positive with a genomic target will be assigned to one of the three groups in Arm 1 and receive genomically directed therapy.

• Arm 1a: DNA Repair pathway = talazoparib + capecitabine (CLOSED)

• Arm 1b: Immunotherapy pathway = pembrolizumab + capecitabine (CLOSED)

• Arm 1c: PI3K Pathway = inavolisib + capecitabine ---> +/- standard of care pembrolizumab

• Arm 1d: DNA Repair + Immunotherapy = talazoparib + capecitabine +/- standard of care pembrolizumab

Participants that are plasma ctDNA positive without a genomic target will be assigned to Arm 2 and receive capecitabine and pembrolizumab or treatment of physician's choice.

Participants that are plasma ctDNA negative will be assigned to Arm 3 and receive any of the following based on patient and physician decision: no therapy/observation, capecitabine and pembrolizumab or treatment of physician's choice. ;

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Triple Negative Breast Cancer
• Triple Negative Breast Neoplasms

• NCT number: NCT04849364
• Study type: Interventional
• Source: Hoosier Cancer Research Network
• Contact: Bryan P Schneider, MD
• Phone: 317-948-3885
• Email: bpschnei@iu.edu
• Status: Recruiting
• Phase: Phase 2
• Start date: August 24, 2021
• Completion date: January 31, 2034