CAPPA : A Phase II study to evaluate CAPecitabine plus Pembrolizumab as postoperative Adjuvant therapy for Triple Negative Breast Cancer with residual disease after neoadjuvant chemo-immunotherapy

Unicancer19 sites in 1 country220 target enrollmentMarch 11, 2025

DrugsCAPECITABINE, CAPECITABINE PEMBROLIZUMAB CAPECITABINE

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Not specified
Sponsor: Unicancer
Enrollment: 220
Locations: 19
Primary Endpoint: 2-year Invasive disease free survival (iDFS).
Status: Recruiting
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

To evaluate the efficacy of post-operative capecitabine added to pembrolizumab on the invasive disease-free survival (iDFS) as assessed by investigator in subjects with Triple Negative Breast Cancer and 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.

Registry

euclinicaltrials.eu

Start Date

March 11, 2025

End Date

August 1, 2028

Last Updated

5 months ago

Study Type

Interventional

Study Design

Parallel

Investigators

Sponsor

Unicancer

Responsible Party

Principal Investigator

AIT RAHMOUNE Nourredine

Scientific

Unicancer

Eligibility Criteria

Inclusion Criteria

•Experimental arm : 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;
•Experimental arm : 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);
•Experimental arm : Complete resection of the breast tumor(s) (and of any invaded lymph node);
•Experimental arm : No complete pathological response, defined as RCB Class I, II or III (per local assessment);
•Experimental arm : Available representative formalin-fixed paraffin-embedded (FFPE) tumor block from surgery specimen with its histological report;
•Experimental arm : Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2;
•Experimental arm : Adequate organ and bone marrow function. All screening lab tests should be performed within 28 days before randomization;
•External Cohort : Patient information prior to study entry and non-opposition to data collection
•External Cohort : Subject ≥18 years of age ;
•External Cohort : Histologically proven TNBC defined as follows: a. HER2 negativity (ASCO/CAP criteria) b. AND less than 10% of cells stained by immunohistochemistry (IHC) for ER and PgR;

Exclusion Criteria

•Experimental arm : Radiological or clinical evidence of metastatic disease documented by imaging or clinical examination performed during screening period;
•Experimental arm : Patients having received brivudine within 4 weeks prior to inclusion;
•Experimental arm : 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;
•Experimental arm : Pregnant women or women who are breast-feeding;
•Experimental arm : Patients unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial, social, or psychological reasons;
•Experimental arm : Persons deprived of their liberty or under protective custody or guardianship;
•Experimental arm : Participation in another therapeutic trial within the 30 days prior to randomization.
•External Cohort : Radiological or clinical evidence of metastatic disease documented by imaging or clinical examination after surgery.
•External Cohort : Has received capecitabine or other ICI than pembrolizumab in the NAC regimen;
•External Cohort : 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;

Outcomes

Primary Outcomes

2-year Invasive disease free survival (iDFS).

Secondary Outcomes

Efficacy: Overall Survival (OS) is defined as the time from the date of inclusion to the date of death due to any cause. For patients alive, OS will be censored at date of last contact.
Efficacy: 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. For patients alive without distant relapse, DDFS will be censored at date of last contact.
Efficacy : 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
Safety : Safety and tolerability assessed by Adverse Events (AEs) as per the National Cancer Institute Common Toxicity Criteria for Adverse Events version 5.0 (CTCAE v5.0).