Neoadjuvant Pembrolizumab and Carboplatin Plus Paclitaxel for Stage I Triple-negative Breast Cancer

Sponsor
MedSIR
Study ID
NCT06604858
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — DRUG
    Pembrolizumab 200 mg administered every three weeks intravenously on day 1 of each cycle.
  • Carboplatin — DRUG
    Carboplatin: area under the curve (AUC) of 1.5 mg/mL x min (maximum dose of 225 mg), intravenously on day 1, day 8 and day 15 of each 21-days cycle.
  • Paclitaxel — DRUG
    Paclitaxel: 80 mg/m2, intravenously on day 1, day 8 and day 15 of each 21-days cycle.

Study Details

This is a single arm, proof of concept phase II clinical trial to evaluate the combination of Pembrolizumab and Carboplatin plus Paclitaxel in patients with localized TNBC (tumor size ≥ 10 mm and ≤ 20 mm by mammogram and/or ultrasound, and/or ≥ 10 mm and ≤ 25 mm by breast MRI if performed within 2 weeks after biopsy, considering possible tissue inflammation post-procedure, as per local assessment), node-negative status (by clinical exam and local radiological evaluation) and who have not previously received chemotherapy, targeted therapy, and/or radiotherapy for invasive breast cancer.

Key Dates

First listed
Sep 20, 2024
Start date
May 29, 2025
Status verified
Jul 2026
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
31 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Pembrolizumab and Carboplatin plus Paclitaxel
    Patients will receive treatment with Pembrolizumab and Carboplatin plus Paclitaxel up to surgery. The treatment is composed by 4 cycles of 21 days each (patients will be treated for a total of 84 days) and treatment will last until surgery.

Primary Outcome Measure

To assess pathological complete response (pCR) rate in all patients. [ Time Frame: From baseline up to 84 days (the date of breast surgery). ]

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