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The BETTER Trial: Optimizing Treatment for Early-Stage Triple-Negative Breast Cancer

This study, called the BETTER Trial, is looking at whether specific blood and imaging tests can help doctors understand if people with early-stage triple-negative breast cancer (TNBC) have already responded well to chemotherapy before surgery. Participants will receive a combination of drugs: Paclitaxel, Carboplatin, and Pembrolizumab (an immunotherapy). The study is open to adults aged 18 and older who have been diagnosed with early-stage TNBC, which is defined by specific levels of ER, PR, and HER2 biomarkers. The main goal is to see how safe these treatments are and to track any side effects. The study aims to enroll 200 participants, but its current status is unclear.

Study design
This is an interventional study planning to enroll 200 participants. It is a Phase 2 study, meaning it's testing the effectiveness and safety of the treatments.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety and side effects will be measured throughout the study, which is expected to last an average of one year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07610525

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

Not Yet Recruiting
PHASE2Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~200 participants
Updated 2026-05-28 on ClinicalTrials.gov
What's tested:Paclitaxel + CarboplatinPembrolizumab

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and adverse events (AEs).
Measured over Through study completion; an average of 1 year

Conditions

Triple Negative Breast Cancer
Blood and Image Guided
Optimization of Neoadjuvant Therapy
Phase 2

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Triple-negative breast cancer

NCT07610525

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • MD Anderson Cancer Center

    Houston, Texasstudy coordinator listed

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Clinton Yam, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Akshara S Raghavendra, MD
[email protected]
713-792-2817
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Safety and adverse events (AEs).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