Capecitabine Plus Pembrolizumab in Patients With Triple Negative Breast Cancer After Chemo-immunotherapy and Surgery
- Conditions
- Triple Negative Breast Neoplasms
- Interventions
- Registration Number
- NCT05973864
- Lead Sponsor
- UNICANCER
- 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 (TNBC) with residual disease after neoadjuvant chemotherapy associated with pembrolizumab.
- 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 patients with residual disease.
An external cohort with patients treated with pembrolizumab as part of standard care after surgery, for localized TNBC without pCR after NAC, and with similar eligibility criteria, will be registered in an ambispective way, allowing comparisons between the experimental arm and this external cohort. All the centers involved in the study will participate in the registration of the needed information concerning this cohort.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 220
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental arm : Pembrolizumab and capecitabine Pembrolizumab injection * Pembrolizumab will be administered at a fixed dose of 200 mg every 3 weeks (Q3W), with a total of 9 cycles at adjuvant phase of the treatment; * Capecitabine will be administrated at a dose of 1250 mg/m² twice a day (BID) (14 days on / 7 days off) for a total of 8 cycles, with a dose reduction at 825 mg/m² BID during radiotherapy if indicated * Local radiotherapy will be performed as per standard practice if indicated. Experimental arm : Pembrolizumab and capecitabine Capecitabine tablets * Pembrolizumab will be administered at a fixed dose of 200 mg every 3 weeks (Q3W), with a total of 9 cycles at adjuvant phase of the treatment; * Capecitabine will be administrated at a dose of 1250 mg/m² twice a day (BID) (14 days on / 7 days off) for a total of 8 cycles, with a dose reduction at 825 mg/m² BID during radiotherapy if indicated * Local radiotherapy will be performed as per standard practice if indicated. Experimental arm : Pembrolizumab and capecitabine Local radiotherapy * Pembrolizumab will be administered at a fixed dose of 200 mg every 3 weeks (Q3W), with a total of 9 cycles at adjuvant phase of the treatment; * Capecitabine will be administrated at a dose of 1250 mg/m² twice a day (BID) (14 days on / 7 days off) for a total of 8 cycles, with a dose reduction at 825 mg/m² BID during radiotherapy if indicated * Local radiotherapy will be performed as per standard practice if indicated. Standard of care (SOC) treated external cohort Pembrolizumab injection A standard of care treated external cohort with patients treated with pembrolizumab as postoperative treatment for localized TNBC without pCR after NAC, and with similar eligibility criteria will be registered in an ambispective way, allowing comparisons between the experimental arm and this external cohort. All the centres involved in the study will participate the registration of the needed information concerning this cohort. Standard of care (SOC) treated external cohort Local radiotherapy A standard of care treated external cohort with patients treated with pembrolizumab as postoperative treatment for localized TNBC without pCR after NAC, and with similar eligibility criteria will be registered in an ambispective way, allowing comparisons between the experimental arm and this external cohort. All the centres involved in the study will participate the registration of the needed information concerning this cohort.
- Primary Outcome Measures
Name Time Method 2-year Invasive Disease-free survival (iDFS) 2 years Invasive disease free survival (iDFS) defined as time from randomization to the first of the following events: local, regional or distant recurrence, or second primary cancer (including contralateral) or death due to any cause.
- Secondary Outcome Measures
Name Time Method Overall survival (OS) From inclusion to death of any cause, up to 3.5 years. The overall survival is the length of time from randomization that patients enrolled in the study are still alive.
Distant disease-free survival (DDFS) Throughout study completion, up to 3.5 years. Distant disease-free survival (DDFS) is defined as the time from the date of inclusion to the date of distant relapse or death due to any cause, whichever occurs first.
Efficacy (iDFS, OS and DDFS) Throughout study completion, up to 3.5 years. iDFS, OS and DDFS will also be compared to the external cohort of TNBC patients without pCR after NAC and treated with adjuvant pembrolizumab as part of standard of care after surgery .
Acute and late toxicity during the study Throughout study completion, up to 3.5 years. The National Cancer Institute-Common Terminology Criteria for Adverse Events version 5 (NCI-CTCAE v5) is widely accepted in the community of oncology research as the leading rating scale for adverse events. This scale, divided into 5 grades (1 = "mild", 2 = "moderate", 3 = "severe", 4 = "life-threatening", and 5 = "death") determined by the investigator, will make it possible to assess the severity of the disorders.
Trial Locations
- Locations (7)
Centre Hospitalier de la Côte Basque
🇫🇷Bayonne, France
CHD Vendee
🇫🇷La Roche Sur Yon, France
Clinique de La Croix du sud
🇫🇷Quint-fonsegrives, France
Institut Godinot
🇫🇷Reims, France
Institut Claudius Regaud, IUCT Oncopole
🇫🇷Toulouse, France
Institut de Cancérologie de Lorraine
🇫🇷Vandoeuvre Les Nancy Cedex, France
Institut Curie
🇫🇷Saint-Cloud, France