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

May 21, 2026 updated by: M.D. Anderson Cancer Center

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center
        • Principal Investigator:
          • Clinton Yam, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 of birth control; abstinence) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female Participants, between the onset of menses (as early as 8 years of age) and 55 years unless the Participant presents with an applicable exclusionary factor which may be one of the following:

    • 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

Exclusion Criteria

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort A1
Cohort A1 Omiting AC/PB: Paclitaxel+Carboplatin+Pembrolizumab x 4 cycles
Drug: Pembrolizumab
Given by IV
Drug: Paclitaxel + Carboplatin
Given by IV
Experimental: Cohort A2
Cohort A2 Receiving AC/PB: Paclitaxel+Carboplatin+Pembrolizumab x 4 cycles + (AC/PB) x 4 cycles
Drug: Pembrolizumab
Given by IV
Drug: Paclitaxel + Carboplatin
Given by IV
Experimental: Cohort B1
Cohort B1 Receiving AC/PB: Paclitaxel+Carboplatin+Pembrolizumab x 4 cycles + (AC/PB) x 4 cycles
Drug: Pembrolizumab
Given by IV
Drug: Paclitaxel + Carboplatin
Given by IV
Experimental: Cohort B2
Cohort B2 Omiting AC/PB: Paclitaxel+Carboplatin+Pembrolizumab x 4 cycles
Drug: Pembrolizumab
Given by IV
Drug: Paclitaxel + Carboplatin
Given by IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and adverse events (AEs).
Time Frame: Through study completion; an average of 1 year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Clinton Yam, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 5, 2026

Primary Completion (Estimated)

January 15, 2029

Study Completion (Estimated)

January 15, 2031

Study Registration Dates

First Submitted

May 19, 2026

First Submitted That Met QC Criteria

May 21, 2026

First Posted (Actual)

May 28, 2026

Study Record Updates

Last Update Posted (Actual)

May 28, 2026

Last Update Submitted That Met QC Criteria

May 21, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026-0293
  • NCI-2026-03701 (Other Identifier: NCI-CTRP Clinical Registry)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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