Blood and imagE-guided Optimization of Neoadjuvant Therapy in People With Early Stage Triple-negative Breast cancER - the BETTER Trial

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Stage IV (metastatic) breast cancer

History of any prior (ipsi- or contralateral) invasive breast cancer. Note: Prior DCIS is allowed.

History of other malignancies within the last 5 years except for appropriately treated carcinoma in situ of the cervix, nonmelanoma skin carcinoma, stage I uterine cancer, or other non-breast malignancies with an outcome similar to those mentioned above.

Prior excisional biopsy of the primary invasive breast cancer.

Trial design

Treatments tested in this trial

  • Paclitaxel + Carboplatin
  • Pembrolizumab

Treatment groups

200 Participants
are divided into 4 treatment groups

Sponsors and collaborators