Actively Recruiting
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
Led by M.D. Anderson Cancer Center · Updated on 2026-03-04
28
Participants Needed
1
Research Sites
174 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To look at the effectiveness of the combination of pembrolizumab, carboplatin, and paclitaxel in participants with stage 1 cT1b-T1cN0M0 Triple Negative Breast Cancer.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed triple negative breast cancer (ER <10%, PR <10%, HER2-negative) per 2018 ASCO CAP guidelines
- AJCC 8 anatomic tumor Stage 1 T1b-T1c, N0, M0 with pathologically assessed suspicious nodes if present
- Male or female participants aged 18 years or older at consent signing
- Male participants agree to use contraception during treatment and for at least 120 days after last dose
- Female participants must not be pregnant or breastfeeding and either not of childbearing potential or agree to contraceptive guidance during treatment and for at least 120 days after last dose
- Recovery to ≤Grade 1 or baseline from prior anticancer therapy adverse events
- Provide written informed consent
- Provide archival or newly obtained tumor tissue sample not previously irradiated
- ECOG performance status of 0 to 1 assessed within 7 days prior to first dose
- Adequate organ function based on specified laboratory values within 10 days prior to treatment
- Non-English speakers allowed if interpretation by licensed interpreter is available
- For participants with HIV: well-controlled HIV with negative viral load on ART and no AIDS-defining infections within past 12 months
- For Hepatitis B positive: received antiviral therapy for at least 4 weeks with undetectable viral load and remain on therapy
- For Hepatitis C positive: completed curative antiviral therapy at least 4 weeks prior with undetectable viral load
You will not qualify if you...
- Stage 2, 3, or 4 triple negative breast cancer
- Hormone receptor positive or HER2-positive breast cancer
- Positive pregnancy test within 72 hours prior to dosing for women of childbearing potential
- Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, or other T-cell receptor targeting agents
- Prior systemic anticancer therapy or investigational agents within 4 weeks before treatment
- Prior radiotherapy within 2 weeks before treatment or radiation-related toxicities requiring corticosteroids
- Receipt of live or live-attenuated vaccines within 30 days before treatment
- Immunodeficiency, chronic systemic steroid therapy >10 mg prednisone equivalent daily within 7 days before treatment, or other immunosuppressive therapy
- Active malignancy progressing or requiring treatment within past 3 years excluding certain skin and bladder cancers
- Active CNS metastases or carcinomatous meningitis
- Severe hypersensitivity (≥Grade 3) to study treatment components
- Active autoimmune disease requiring systemic treatment in past 2 years except replacement therapy
- History or current pneumonitis or interstitial lung disease requiring steroids
- Active infection requiring systemic therapy >14 days from treatment start
- Concurrent active Hepatitis B or C infection unless stable as per criteria
- Incomplete recovery from major surgery or ongoing surgical complications
- Psychiatric or substance abuse disorders interfering with trial participation
- Pregnancy, breastfeeding, or expecting to conceive or father children during the study and 120 days after last dose
- History of allogenic tissue or solid organ transplant
- Contraindications to doxorubicin therapy including recent myocardial infarction, severe heart issues, or prior max cumulative anthracycline treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
O
Oluchi Oke, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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