Actively Recruiting
Neoadjuvant Treatment Optimization Via MRI-Guided De-Escalation in Stage II-III Triple-Negative Breast Cancer - A Phase 2 Study
Led by Tel-Aviv Sourasky Medical Center · Updated on 2026-01-08
54
Participants Needed
2
Research Sites
143 weeks
Total Duration
On this page
Sponsors
T
Tel-Aviv Sourasky Medical Center
Lead Sponsor
S
Sheba Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
Triple-negative breast cancer (TNBC) is an aggressive form of breast cancer lacking estrogen receptor, progesterone receptor, and HER2 expression, accounting for about 15% of cases and linked to higher risks of early recurrence and death. This trial explores a new approach to treating stage II-III TNBC by using MRI to guide the reduction of chemotherapy intensity after initial treatment, aiming to avoid the more toxic anthracycline drugs in patients who respond well early on. Participants will receive four cycles of paclitaxel-carboplatin combined with pembrolizumab, followed by a breast MRI to assess their response. Those showing a complete radiologic response will proceed directly to surgery, skipping the second phase of anthracycline-containing chemotherapy, while others will complete the full regimen. After surgery, additional treatments may be given based on pathology results and decisions by the patient and doctor. Throughout the study, participants will undergo regular assessments including imaging, blood tests for tumor DNA, and quality of life questionnaires to monitor treatment effects and recovery. The main goal is to measure the rate of complete disappearance of invasive cancer in those with a complete MRI response who have early surgery. The study also tracks survival outcomes and patient experiences over several years, involving about 54 patients in total.
CONDITIONS
Brief Title
MRI-Guided Neoadjuvant Treatment De-Escalation in Stage II-III TNBC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Eligible for the KEYNOTE-522 chemotherapy and immunotherapy regimen as determined by a physician
- Signed written informed consent
- Histologically confirmed primary infiltrating breast cancer with less than 1% estrogen and progesterone receptor expression and no HER2 overexpression
- Stage T2-3N0 or T1-3N1 disease based on TNM staging
- Lymph node status evaluated by ultrasound and biopsy if suspicious
- No distant metastases detected on FDG-PET scan within 35 days before enrollment
- Age 18 years or older
- WHO performance status of 2 or less
- Visible breast tumor on contrast-enhanced MRI performed within 35 days before registration
- Eligible patients with autoimmune disease may participate based on physician discretion
- Adequate bone marrow, liver, kidney function, and heart function (LVEF 50% or higher) within 21 days before enrollment
- Women of childbearing potential and men must agree to abstain or use effective contraception during treatment and for 6 months after last pembrolizumab dose, with negative pregnancy test if applicable
You will not qualify if you...
- Currently breastfeeding
- Presence of a second primary infiltrating breast cancer in the opposite or same breast that is not triple-negative
- Receiving other anti-cancer treatments or investigational drugs
- Psychological, social, or geographic conditions that may affect study compliance
- History of second malignancy unless adequately treated and approved by the principal investigator
- Prior excisional biopsy of primary tumor or lymph node dissection before study treatment
- Immunodeficiency or ongoing immunosuppressive therapy exceeding 10 mg prednisone equivalent daily within 7 days before study start
- Any condition or treatment that could interfere with study results or participant cooperation as judged by the investigator
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 24 weeks
Participants receive the KEYNOTE-522 chemotherapy and immunotherapy regimen. Those who show a complete response on MRI after the first phase proceed to early surgery without completing the full treatment phase.
Multiple visits during treatment phases and MRI assessments
Trial Site Locations
Total: 2 locations
1
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
Actively Recruiting
2
Sheba Medical Center
Tel Litwinsky, Israel
Actively Recruiting
Research Team
T
Tal Sella, MD
Y
Yael Bar, MD PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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