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Phase 2 Study of Pembrolizumab with Chemotherapy for Stage 1 Triple Negative Breast Cancer

This study is looking at how well a combination of medicines works for people with Stage 1 Triple Negative Breast Cancer (cT1b-T1cN0M0). This type of breast cancer is negative for estrogen receptors (ER), progesterone receptors (PR), and HER2. The study will test pembrolizumab along with carboplatin and paclitaxel. Some participants may also receive doxorubicin and cyclophosphamide. Researchers want to see if this combination helps shrink the cancer before surgery. They are also checking for any side effects. You may be eligible if you are 18 or older and have this specific type of Triple Negative Breast Cancer, confirmed by pathology tests.

Study design
This is an open-label, single-center study, meaning everyone knows what treatments are being given. It plans to enroll 28 participants.
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 through study completion, which is an average of 1 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.

NCT06318897

Open-label, Single Center, Single-arm, Phase 2 Study of Neoadjuvant Pembrolizumab in Combination With Carboplatin and Paclitaxel in Patients With Stage 1 cT1b-T1cN0M0 Triple Negative Breast Cancer

Recruiting
PHASE2Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~28 participants
Updated 2026-03-04 on ClinicalTrials.gov
What's tested:CarboplatinPaclitaxelPembrolizumabDoxorubicinCyclophosphamide

At a glance

Recruiting sites
1 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

Stage 1 cT1b-T1cN0M0
Triple Negative Breast Cancer

Explore related trials

Triple-negative breast cancer

NCT06318897

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

    Recruiting

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

  • Oluchi Oke, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Oluchi Oke, MD
[email protected]
(832) 729-8362
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

Known history of HBV or HCV infection
As mandated by local health authority 13.1 Hepatitis B positive Participants
Participants who are HBsAg positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization.
Participants should remain on anti-viral therapy throughout study intervention and follow local guidelines for HBV anti-viral therapy post completion of study intervention. 13.2 Participants with history of HCV infection are eligible if HCV viral load is undetectable at screening.
Participants must have completed curative anti-viral therapy at least 4 weeks prior to randomization.

Exclusion

Known history of HBV and HCV infection
As mandated by local health authority 17. Has not adequately recovered from major surgery or has ongoing surgical complications. 18. Has a history or current evidence of any condition, therapy, or laboratory abnormality or other circumstance that might confound the results of the study, interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator. 19. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. 20. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment. 21. Has had an allogenic tissue/solid organ transplant. 22. Participants with the following contraindications to doxorubicin therapy: recent myocardial infarction; severe myocardial insufficiency; severe arrhythmias; previous treatment with complete cumulative doses of doxorubicin, daunorubicin, idarubicin, and/or other anthracyclines and anthracenedione.

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