Blood and imagE-guided Optimization of Neoadjuvant Therapy in People With Early Stage Triple-negative Breast cancER - the BETTER Trial
2 other identifiers
interventional
200
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2026
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 19, 2026
CompletedFirst Posted
Study publicly available on registry
May 28, 2026
CompletedStudy Start
First participant enrolled
November 5, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
January 15, 2029
Study Completion
Last participant's last visit for all outcomes
January 15, 2031
May 28, 2026
May 1, 2026
2.2 years
May 19, 2026
May 21, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Safety and adverse events (AEs).
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Through study completion; an average of 1 year
Study Arms (4)
Cohort A1
EXPERIMENTALCohort A1 Omiting AC/PB: Paclitaxel+Carboplatin+Pembrolizumab x 4 cycles
Cohort A2
EXPERIMENTALCohort A2 Receiving AC/PB: Paclitaxel+Carboplatin+Pembrolizumab x 4 cycles + (AC/PB) x 4 cycles
Cohort B1
EXPERIMENTALCohort B1 Receiving AC/PB: Paclitaxel+Carboplatin+Pembrolizumab x 4 cycles + (AC/PB) x 4 cycles
Cohort B2
EXPERIMENTALCohort B2 Omiting AC/PB: Paclitaxel+Carboplatin+Pembrolizumab x 4 cycles
Interventions
Eligibility Criteria
You may qualify if:
- 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
- Postmenopausal (no menses greater than or equal to 12 consecutive months).
- History of hysterectomy or bilateral salpingo-oophorectomy.
- Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).
- History of bilateral tubal ligation or another surgical sterilization procedure.
- Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject/Partner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
- Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of study.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- No active viral hepatitis (hepatitis B or C) at baseline
You may not qualify if:
- 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.
- Participants with cognitive impairment/psychiatric illness/social situations that would limit compliance with study requirements.
- Participants not medically eligible for chemotherapy with taxanes, carboplatin, and/or anthracycline-based chemotherapy regimens
- Participants not medically eligible for immunotherapy
- Pregnant women are excluded from this study because of the potentially detrimental effect of magnetic resonance imaging on the fetus.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Clinton Yam, MD
M.D. Anderson Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 19, 2026
First Posted
May 28, 2026
Study Start (Estimated)
November 5, 2026
Primary Completion (Estimated)
January 15, 2029
Study Completion (Estimated)
January 15, 2031
Last Updated
May 28, 2026
Record last verified: 2026-05