Blood and imagE-guided Optimization of Neoadjuvant Therapy in People With Early Stage Triple-negative Breast cancER - the BETTER Tria
M.D. Anderson Cancer Center
Summary
To learn whether certain blood and imaging tests can show which people with early-stage TNBC may already have had a complete response to chemotherapy before they go to surgery.
Description
Primary Objectives To determine the rate of pCR in participants with high-risk, early-stage TNBC who have no residual enhancement on MRI and undetectable ctDNA after receiving neoadjuvant pembrolizumab plus carboplatin plus paclitaxel and proceed with surgery without receiving doxorubicin and cyclophosphamide in the neoadjuvant setting
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria * Participants must be 18 years of age or older, able to understand and give written informed consent. * Histologically proven TNBC, defined as ER ≤10%, PR ≤10%, and HER2 negative based on the 2023 ASCO/CAP guidelines. * Clinical stage T1cN1-2 or T2-4N0-2 TNBC according to the primary tumor-regional lymph node anatomic staging criteria of the American Joint Committee on Cancer (AJCC), 8th edition. * Medically eligible to receive immunotherapy in combination with chemotherapy as part of standard of care * Willingness to use adequate contraception (hormonal or barrier method…
Interventions
- DrugPaclitaxel + Carboplatin
Given by IV
- DrugPembrolizumab
Given by IV
Location
- MD Anderson Cancer CenterHouston, Texas