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Not yet recruitingPhase 2

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

The BETTER trial is for adults with early-stage triple-negative breast cancer (TNBC). It tests whether blood tests and imaging scans can show who has no cancer left after chemotherapy, before surgery.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older and able to understand and sign a consent form.
  • Have TNBC confirmed by a tissue test: estrogen and progesterone receptor levels of 10% or less, and a negative HER2 test.
  • Have cancer stage T1cN1–2 or T2–4N0–2. These stages describe the tumor's size or spread nearby and cancer in nearby lymph nodes.
  • Be medically able to receive chemotherapy with immunotherapy, a treatment that helps the immune system fight cancer.
  • Be able to care for yourself and be out of bed or a chair for at least half of your waking hours (ECOG score 0–2).
  • Have no active hepatitis B or C, which are viral liver infections.
  • If you can become pregnant, use study-approved birth control before and during the study, or avoid sex as required. Tell your doctor right away if you become pregnant or think you may be pregnant.
  • Men must use approved birth control before and during the study and for 4 months afterward.

Who can't join

  • Have stage IV breast cancer, meaning it has spread to distant parts of the body.
  • Have had invasive breast cancer in either breast before. Prior DCIS, cancer that stayed inside the milk ducts, is allowed.
  • Have had another cancer in the past 5 years, except certain treated early cervical, skin, or uterine cancers, or other non-breast cancers with a similar outlook.
  • Have already had a biopsy that removed the main invasive breast tumor.
  • Have problems with thinking, mental health, or life circumstances that would prevent you from following study requirements.
  • Cannot safely receive the required chemotherapy drugs: taxanes, carboplatin, and/or anthracyclines.
  • Cannot safely receive immunotherapy.
  • Are pregnant.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

TX