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

NCT04849364 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2025-05-31

Study results available
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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).

Conditions

Interventions

DRUG

Capecitabine

Capecitabine 1000 mg/m2 BID Orally 14 days on and 7 days off Cycle = 21 days; Total of 8 cycles

DRUG

Talazoparib

Talazoparib Cycle 1: 0.75 mg then Cycle 2-8: 1 mg Cycle = 21 days; Total of 8 cycles

DRUG

Pembrolizumab

Per standard of care.

DRUG

Inavolisib

Inavolisib Cycle 1: 6 mg then Cycle 2-8: 9mg Orally 21 days on Cycle = 21 days; Total of 8 cycles

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • Pfizer

    collaborator INDUSTRY

  • Foundation Medicine

    collaborator INDUSTRY

  • Indiana University

    collaborator OTHER

  • Vera Bradley Foundation for Breast Cancer

    collaborator OTHER

  • Bryan Schneider, MD

    lead OTHER

Principal Investigators

  • Bryan P Schneider, MD · Indiana University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-24
Primary Completion
2024-10-24
Completion
2024-12-02
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04849364 on ClinicalTrials.gov