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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Bryan Schneider, MD
Study ID
NCT04849364
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Capecitabine — DRUG
    Capecitabine 1000 mg/m2 BID Orally 14 days on and 7 days off Cycle = 21 days; Total of 8 cycles
  • Talazoparib — DRUG
    Talazoparib Cycle 1: 0.75 mg then Cycle 2-8: 1 mg Cycle = 21 days; Total of 8 cycles
  • Pembrolizumab — DRUG
    Per standard of care.
  • Inavolisib — DRUG
    Inavolisib Cycle 1: 6 mg then Cycle 2-8: 9mg Orally 21 days on Cycle = 21 days; Total of 8 cycles

Study Details

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).

Key Dates

Start date
Aug 24, 2021
Status verified
May 2025
Primary completion
Oct 24, 2024
Completion
Dec 2, 2024

Study Design

Enrollment
52 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1
    Arm 1a: Patients who are ctDNA-positive and harbor a genomic target. DNA repair pathway = talazoparib + capecitabine (CLOSED) Arm 1b: Patients who are ctDNA-positive and harbor a genomic target. Immunotherapy pathway = pembrolizumab + capecitabine (CLOSED) Arm 1c: Patients who are ctDNA-positive and harbor a genomic target. PI3K Pathway = inavolisib + capecitabine ---\> +/- standard of care pembrolizumab Arm 1d: Patients who are ctDNA-positive and harbor a genomic target. DNA Repair + Immunotherapy = talazoparib + capecitabine +/- standard of care pembrolizumab
  • Active Comparator: Arm 2
    Arm 2 subjects have plasma ctDNA positive but do not have a genomically driven treatment option. Treatment of physician's choice will be given with consideration for capecitabine and pembrolizumab. Dose, schedule and duration of treatment to be determined by treating physician.
  • Active Comparator: Arm 3
    Arm 3 subjects have plasma ctDNA negative. Treatment of patient and physician's choice will be given with consideration for capecitabine and pembrolizumab. Dose, schedule and duration of treatment to be determined by treating physician.

Primary Outcome Measure

ARM 1c: Disease Free Survival (DFS) at 2 Years [ Time Frame: 2 years ]

Locations (13)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294-
Georgetown UniversityWashington D.C.District of Columbia20057-
Memorial Healthcare SystemHollywoodFlorida33028-
Miami Cancer Institute at Baptist Health, Inc.MiamiFlorida33176-
University of Chicago Medical CenterChicagoIllinois60637-
Indiana University Melvin and Bren Simon Comprehensive Cancer CenterIndianapolisIndiana46202-
Summit HealthBerkeley HeightsNew Jersey07922-
Novant Health Cancer InstituteWinston-SalemNorth Carolina27103-
Mays Cancer Center at UT Health San AntonioSan AntonioTexas78229-
University of WisconsinMadisonWisconsin53705-
Froedtert and The Medical College of WisconsinMilwaukeeWisconsin53226-
Advocate Aurora Research Institute (Illinois)WauwatosaWisconsin53226-
Aurora Health CareWauwatosaWisconsin53226-

Related coverage on Hipa.ai

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