Status:
RECRUITING
Capecitabine Plus Pembrolizumab in Patients With Triple Negative Breast Cancer After Chemo-immunotherapy and Surgery
Lead Sponsor:
UNICANCER
Conditions:
Triple Negative Breast Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The goal of this clinical trial is to evaluate the efficacity and safety of pembrolizumab and capecitabine on the invasive disease-free survival, in participants who have triple negative breast cancer...
Detailed Description
We propose to evaluate the benefit in 2-year iDFS and safety of adding capecitabine to pembrolizumab in post-operative phase of pembrolizumab-containing treatment, in the subgroup of localized TNBC pa...
Eligibility Criteria
Inclusion
- • CRITERIA FOR EXPERIMENTAL ARM :
- Inclusion criteria (for experimental arm):
- Patients eligible for this study must meet ALL of the following criteria:
- Patient must have signed a written informed consent prior to any trial specific procedures. When the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in writing the patient's consent;
- Subject ≥18 years of age on day of signing informed consent form (ICF);
- Histologically proven TNBC defined as follows:
- HER2 negativity (ASCO/CAP criteria)
- AND less than 10% of cells stained by immunohistochemistry (IHC) for ER and PgR;
- TNBC patients previously treated by standard neoadjuvant chemotherapy with a minimum of 6 cycles of immunochemotherapy containing pembrolizumab, per standard of care (and pembrolizumab label) and anthracyclines and/or taxanes (with/without carboplatin). Other drugs may be acceptable following discussion with the sponsor (with the exclusion of capecitabine);
- Complete resection of the breast tumor(s) (and of any invaded lymph node);
- No complete pathological response, defined as RCB Class I, II or III (per local assessment);
- Available representative formalin-fixed paraffin-embedded (FFPE) tumor block from surgery specimen with its histological report;
- Eastern Cooperative Oncology Group (ECOG) Performance Status \<2;
- Adequate organ and bone marrow function. All screening lab tests should be performed within 28 days before inclusion;
- Resolution to at least grade 1 of all acute toxicities from previous therapies including immune-related toxicity due to pembrolizumab, except alopecia and grade 2 immune-related endocrinopathies controlled by hormone replacement which are allowed;
- Minimal/maximal period for prior treatments (i.e. minimal delay from last dose of prior treatment to C1D1): breast surgery (the wound must have healed prior to C1D1) ≥2 weeks (maximum 10 weeks); last pembrolizumab injection ≥3 weeks;
- Women of child-bearing potential must have a negative serum pregnancy test within 7 days before C1D1;
- Women of child-bearing potential and male patients must agree to use 1 effective form of contraception from the time of the negative pregnancy test up to 6 months after the last dose of study drugs;
- Patient 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).
- Non-inclusion criteria (for experimental arm):
- Patients eligible for this study must not meet ANY of the following criteria:
- Radiological or clinical evidence of metastatic disease documented by imaging or clinical examination performed during screening period;
- Has received capecitabine or other ICI than pembrolizumab in the NAC regimen;
- Has a known additional malignancy, excepted skin basal cell carcinoma, squamous cell carcinoma of the skin, or in situ cervical cancer or previously treated malignancy with no evidence of disease for ≥2 years;
- Presents a contraindication to continue pembrolizumab treatment as per respective SmPC including known hypersensitivity;
- Previous immune-related adverse event of any grade due to pembrolizumab that led to permanent discontinuation of pembrolizumab;
- Presents a contraindication to capecitabine treatment as per SmPC (See EMA website for most recent edition of SmPC);
- Complete DPD (Dihydropyrimidine Dehydrogenase) deficiency (a systematic screening of DPD deficiency must be performed);
- Patient with active infection ;
- Patients with history of uncontrolled or symptomatic cardiac disease ;
- Patients having received brivudine within 4 weeks prior to inclusion;
- Require the use of one of the following forbidden treatments during the study treatment period:
- Any investigational anticancer therapy other than the protocol specified treatment;
- Any concurrent chemotherapy, immunotherapy, biologic for cancer treatment, other than the ones stated in the protocol;
- Pregnant women or women who are breast-feeding;
- Patients unwilling or unable to comply with the medical follow-up required by the trial because of 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 randomization.
- CRITERIA FOR STANDARD OF CARE TREATED EXTERNAL COHORT
- Inclusion criteria (for standard of care treated external cohort) :
- Patients eligible for this cohort must meet ALL of the following criteria:
- Patient information prior to study entry and non-opposition to data collection
- Subject ≥18 years of age ;
- Histologically proven TNBC defined as follows:
- HER2 negativity (ASCO/CAP criteria)
- AND less than 10% of cells stained by immunohistochemistry (IHC) for ER and PgR;
- TNBC patients previously treated by standard neoadjuvant chemotherapy with a minimum of 6 cycles of immunochemotherapy containing pembrolizumab, per standard of care (and pembrolizumab label) and anthracyclines and/or taxanes (with/without carboplatin). Other drugs may be acceptable following discussion with the sponsor (with the exclusion of capecitabine);
- Complete resection of the breast tumor(s) (and of any invaded lymph node);
- No complete pathological response, defined as RCB Class I, II or III (per local assessment);
- Patient should have received at least one injection of pembrolizumab as post-surgery treatment (concomitantly or after radiotherapy).
- Non-exclusion criteria (for standard of care treated external cohort) :
- Patients eligible for this study must not meet ANY of the following criteria:
- Radiological or clinical evidence of metastatic disease documented by imaging or clinical examination after surgery.
- Has received capecitabine or other ICI than pembrolizumab in the NAC regimen;
- Has a known additional malignancy, excepted skin basal cell carcinoma, squamous cell carcinoma of the skin, or in situ cervical cancer or previously treated malignancy with no evidence of disease for ≥2 years;
- Any investigational anticancer therapy (chemotherapy, immunotherapy, biologic for cancer treatment) other than pembrolizumab only as adjuvant treatment.
Exclusion
Key Trial Info
Start Date :
March 11 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2028
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT05973864
Start Date
March 11 2025
End Date
August 1 2028
Last Update
November 17 2025
Active Locations (20)
Enter a location and click search to find clinical trials sorted by distance.
1
CHU Amiens Picardie_Site Sud
Amiens, France, 80054
2
Institut Sainte Catherine
Avignon, France, 84918
3
Centre Hospitalier de la Côte Basque
Bayonne, France, 64109
4
CHU Jean Minoz
Besançon, France