drugset / Trial / NCT04849364
Circulating Tumor DNA Enriched, Genomically Directed Post-neoadjuvant Trial for Patients With Residual Triple Negative Breast Cancer
Phase 2
Terminated
52 enrolled
Bryan Schneider, MD
Foundation Medicine · collabGenentech, Inc. · collabIndiana University · collabPfizer · collabVera Bradley Foundation for Breast Cancer · collab
Non-randomizedParallel-groupOpen-labelTreatment
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).
Timeline
- Start
- 2021-08-24
- Primary completion
- 2024-10-24
- Completion
- 2024-12-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | 1000 mg/m2 | Oral |
| Subject | Inavolisib | Small molecule | 9 mg | Oral |
| Subject | Pembrolizumab | Monoclonal antibody | — | — |
| Subject | Talazoparib | Small molecule | 1 mg | — |