Blood tests may guide breast cancer treatment before surgery
NCT ID NCT07610525
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial is testing whether blood tests and imaging scans can tell if chemotherapy is working in people with early-stage triple-negative breast cancer before they go to surgery. The study will enroll 200 participants who will receive a combination of chemotherapy drugs (paclitaxel and carboplatin) plus the immunotherapy drug pembrolizumab. The goal is to see if these tests can identify who has already had a complete response, potentially allowing for more personalized treatment decisions.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Paclitaxel, Carboplatin, Pembrolizumab
- What this could lead to
- If successful, this could help doctors personalize treatment for early-stage triple-negative breast cancer, potentially avoiding unnecessary surgery or adjusting therapy earlier.
- What could go wrong
- This is an early phase 2 trial with only 200 participants, so results may not apply to everyone. The tests being studied might not accurately predict response, and the combination chemotherapy plus immunotherapy has known side effects like fatigue, nausea, and immune-related reactions.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Nov 2026
An estimate. Start dates often move.
- Expected to finish
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Jan 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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MD Anderson Cancer Center
Houston, Texas, 77030, United States
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