Status:
RECRUITING
Personalizing the Use of Pembrolizumab for Patients Who Have a Strong Response in Early Triple Negative Breast Cancer
Lead Sponsor:
UNICANCER
Conditions:
Breast Cancers
Triple Negative Breast Cancer (TNBC)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 deter...
Detailed Description
Triple-negative breast cancer is a particular type of breast cancer in which the cancer cells do not possess receptors for the proteins estrogen, progesterone, or HER2. The usual treatment for early-s...
Eligibility Criteria
Inclusion
- Patient must have signed a written informed consent prior to any trial-related procedures. When the patient is physically unable to give his written consent, a trusted person of his choice, independent from the investigator or the sponsor, can confirm in writing the patient's consent;
- Age ≥ 18 years;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
- Histologically documented stage II-III breast cancer according to the primary tumour-regional lymph node anatomic staging criteria of the American Joint Committee on Cancer (AJCC), 8th edition as determined by the investigator during radiologic assessment, clinical assessment or both;
- Estrogen receptor (ER) and Progesterone receptor (PR) ≤10%; HER2-negative as per ASCO/CAP guidelines Note: In case of bilateral breast cancer, participation in the study is permitted as long as both tumours are triple negative;
- Patients previously treated with neoadjuvant chemotherapy in combination with pembrolizumab for a minimum of 6 cycles (All systemic chemotherapy must have been completed preoperatively);
- Absence of residual invasive disease in the breast or lymph nodes after the completion of neoadjuvant therapy (Residual ductal carcinoma in situ \[DCIS\] is allowed);
- Have had an adequately excised breast cancer (surgical removal of all clinically evident disease in the breast and lymph nodes) :
- Breast surgery: patients must have undergone either breast-conserving surgery or total mastectomy with histologically negative margins for invasive tumour and DCIS. Patients with margins positive for lobular carcinoma in situ (LCIS) are eligible without additional resection.
- Lymph node surgery: patients must have had sentinel lymph node biopsy (SLNB) and/or axillary lymph node dissection (ALND) to evaluate the pathologic nodal status;
- Patients that have received adequate locoregional radiation therapy or with planned adequate locoregional radiation therapy;
- Adequate organ and bone marrow functions. All screening lab tests should be performed within 28 days before randomisation;
- Absolute Neutrophil Count (ANC) ≥ 1,000 /µL
- Platelets ≥ 100,000 /µL
- Hemoglobin ≥ 9 g/dL
- Creatinine clearance ≥ 30 mL/min for subject with creatinine levels \> 1.5 x institutional upper limit of normal (ULN)
- Total bilirubin ≤ 1.5 x ULN or direct bilirubin ≤ ULN for subjects with total bilirubin levels \> 1.5 ULN (Patients with Gilbert's disease with a total bilirubin ≤ 2.5 x ULN and direct bilirubin within normal limits are permitted)
- Aspartate aminotransferase (ASAT) and alanine aminotransferase (ALAT) ≤ 2.5 x ULN
- Randomisation must take place no more than 12 weeks after breast surgery. Adjuvant radiotherapy is authorized. If given, as per investigator discretion it can be given concurrently with pembrolizumab;
- Patients must not be pregnant or nursing (for women of childbearing potential only, a negative serum pregnancy test must be obtained within 7 days of Cycle 1 Day 1);
- Women of childbearing potential and male patients must agree to use 1 effective form of contraception and up to 4 months after the last dose of study drugs;
- Patients should be able and willing to comply with study visits and procedures as per protocol;
- Patients must be affiliated to a Social Security System (or equivalent).
Exclusion
- Radiological or clinical evidence of metastatic disease (stage IV) documented by imaging or clinical examination;
- Evidence of recurrent disease following preoperative therapy and surgery;
- Any prior history of (ipsi- or contralateral) invasive breast cancer;
- Patients with a prior or concurrent malignancy (other than invasive breast cancer) whose natural history or treatment have the potential to interfere with the safety or efficacy assessment of the investigational regimen;
- Patients for whom pembrolizumab has been permanently discontinued during the neoadjuvant phase of treatment due to pembrolizumab-related AE;
- History of intolerance, including Grade 3 or 4 infusion reaction or hypersensitivity to pembrolizumab or murine proteins or any component of the product;
- Medical conditions that require chronic systemic steroids (\> 10 mg prednisone or equivalent) or any other form of immunosuppressive medication in the past 2 years. Replacement therapy (e.g., thyroxine, insulin, physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment;
- Known active liver disease, e.g. due to HBV, HCV, autoimmune hepatic disorders, or sclerosing cholangitis;
- HIV-infected patients on effective anti-retroviral therapy with detectable viral load within 6 months prior to enrollment;
- Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better;
- Patients unwilling or unable to comply with the medical follow-up required by the trial due to geographic, familial, social, or psychological reasons;
- Persons deprived of their liberty or under protective custody or guardianship;
- Participation in another therapeutic trial within the 30 days prior to randomisation.
Key Trial Info
Start Date :
July 23 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2039
Estimated Enrollment :
2454 Patients enrolled
Trial Details
Trial ID
NCT06606730
Start Date
July 23 2025
End Date
June 1 2039
Last Update
August 26 2025
Active Locations (2)
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1
Cliniques Universitaires Saint Luc Brussels
Brussels, Belgium, 1200
2
Institut Gustave Roussy
Villejuif, France, 94805