Actively Recruiting
Personalizing the Use of Pembrolizumab for Patients Who Have a Strong Response in Early Triple Negative Breast Cancer
Led by UNICANCER · Updated on 2025-08-26
2454
Participants Needed
2
Research Sites
723 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
OPT-PEMBRO trial is a pragmatic, multicentre, international, prospective, non-inferiority, two-arms, randomised (1:1), open-label, Phase III clinical study. The main goal of this research is to determine if patients with triple-negative breast cancer, who experience a complete response after neoadjuvant treatment, have the same chance of avoiding cancer recurrence whether they stop pembrolizumab or continue taking it for an additional 6 months. This research will also take into account patients tolerance to treatment and quality of life.
CONDITIONS
Official Title
Personalizing the Use of Pembrolizumab for Patients Who Have a Strong Response in Early Triple Negative Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before any trial procedures
- Age 18 years or older
- ECOG performance status of 0 to 2
- Histologically confirmed stage II-III breast cancer
- Estrogen and progesterone receptor levels 10% or less; HER2-negative
- Completed at least 6 cycles of neoadjuvant chemotherapy with pembrolizumab
- No remaining invasive cancer in breast or lymph nodes after neoadjuvant treatment (ductal carcinoma in situ allowed)
- Breast surgery with negative margins for invasive cancer and DCIS; lymph node surgery performed
- Received or planned adequate locoregional radiation therapy
- Adequate organ and bone marrow function based on screening labs within 28 days before randomization
- Randomization within 12 weeks after breast surgery
- Not pregnant or nursing with negative pregnancy test if applicable
- Agreement to use effective contraception during and up to 4 months after study drugs
- Willingness and ability to comply with study visits and procedures
- Affiliated with a Social Security System or equivalent
You will not qualify if you...
- Evidence of metastatic (stage IV) or recurrent breast cancer
- Prior history of invasive breast cancer
- Prior or concurrent malignancy interfering with study assessments
- Permanent discontinuation of pembrolizumab during neoadjuvant treatment due to adverse events
- History of severe allergic reaction to pembrolizumab or its components
- Chronic systemic steroid or immunosuppressive medication use in past 2 years
- Active liver disease such as hepatitis B or C, autoimmune liver disorders
- HIV infection with detectable viral load within 6 months prior to enrollment
- Significant cardiac disease or prior cardiotoxic treatment with risk above class 2B
- Inability or unwillingness to comply with follow-up due to personal reasons
- Legal restrictions such as protective custody or deprivation of liberty
- Participation in another therapeutic trial within 30 days before randomization
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Cliniques Universitaires Saint Luc Brussels
Brussels, Belgium, 1200
Actively Recruiting
2
Institut Gustave Roussy
Villejuif, France, 94805
Actively Recruiting
Research Team
S
Sonia Mardinian
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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