Capecitabine Plus Pembrolizumab in Patients With Triple Negative Breast Cancer After Chemo-immunotherapy and Surgery (CAPPA)

November 14, 2025 updated by: UNICANCER

A Phase II Study to Evaluate CAPecitabine Plus Pembrolizumab as Post-operative Adjuvant Therapy for Triple Negative Breast Cancer With Residual Disease After Neoadjuvant Chemo-immunotherapy

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

220

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Amiens, France, 80054
        • Recruiting
        • CHU Amiens Picardie_Site Sud
        • Principal Investigator:
          • Aurélie MOREIRA, MD
        • Contact:
      • Avignon, France, 84918
        • Recruiting
        • Institut Sainte Catherine
        • Principal Investigator:
          • Julien GRENIER, MD
        • Contact:
      • Bayonne, France, 64109
        • Recruiting
        • Centre Hospitalier de la Côte Basque
        • Principal Investigator:
          • Thomas GRELLETY, MD
        • Contact:
      • Besançon, France
        • Recruiting
        • CHU Jean Minoz
        • Principal Investigator:
          • Laura Mansi, MD
        • Contact:
      • Bordeaux, France, 33077
        • Recruiting
        • Polyclinique Bordeaux Nord Aquitaine
        • Principal Investigator:
          • Nadine DOHOLLOU, MD
        • Contact:
      • Caen, France, 14000
      • Dijon, France
        • Recruiting
        • Centre georges-François Leclerc
        • Principal Investigator:
          • Sylvain LADOIRE, MD
        • Contact:
      • La Roche-sur-Yon, France
        • Recruiting
        • CHD Vendée
        • Contact:
        • Principal Investigator:
          • Camille GOISLARD DE MONSABERT, MD
      • Lille, France
        • Recruiting
        • Centre Oscar Lambret
        • Principal Investigator:
          • Claire Cheymol, MD
        • Contact:
      • Lyon, France, 69008
      • Marseille, France, 13009
        • Recruiting
        • Institut Paoli-Calmettes
        • Contact:
        • Principal Investigator:
          • Alexandre DE NONNEVILLE, MD
      • Paris, France, 75005
        • Recruiting
        • Institut Curie
        • Principal Investigator:
          • Delphine LOIRAT, MD
        • Contact:
      • Quint-Fonsegrives, France, 31130
        • Recruiting
        • Clinique de la Croix du Sud
        • Principal Investigator:
          • Francesco RICCI, MD
        • Contact:
      • Reims, France, 51100
      • Saint-Cloud, France, 92210
        • Recruiting
        • Institut Curie
        • Principal Investigator:
          • Delphine LOIRAT, MD
        • Contact:
      • Saint-Nazaire, France
      • Strasbourg, France
        • Recruiting
        • Centre Paul Strauss
        • Contact:
        • Principal Investigator:
          • Thierry PETIT, MD
      • Toulouse, France
        • Recruiting
        • Institut Claudius Regaud, IUCT Oncopole
        • Principal Investigator:
          • Florence DALENC, MD
        • Contact:
      • Tours, France, 37000
        • Recruiting
        • CHU Bretonneau
        • Principal Investigator:
          • Marie-Agnès BY, MD
        • Contact:
      • Vandœuvre-lès-Nancy, France, 54519
        • Recruiting
        • Institut de Cancerologie de Lorraine
        • Principal Investigator:
          • Anne KIEFFER, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

• CRITERIA FOR EXPERIMENTAL ARM :

Inclusion criteria (for experimental arm):

Patients eligible for this study must meet ALL of the following criteria:

  1. 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;
  2. Subject ≥18 years of age on day of signing informed consent form (ICF);

  3. Histologically proven TNBC defined as follows:

    1. HER2 negativity (ASCO/CAP criteria)
    2. AND less than 10% of cells stained by immunohistochemistry (IHC) for ER and PgR;
  4. 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);
  5. Complete resection of the breast tumor(s) (and of any invaded lymph node);
  6. No complete pathological response, defined as RCB Class I, II or III (per local assessment);
  7. Available representative formalin-fixed paraffin-embedded (FFPE) tumor block from surgery specimen with its histological report;
  8. Eastern Cooperative Oncology Group (ECOG) Performance Status <2;
  9. Adequate organ and bone marrow function. All screening lab tests should be performed within 28 days before inclusion;
  10. 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;
  11. 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;
  12. Women of child-bearing potential must have a negative serum pregnancy test within 7 days before C1D1;
  13. 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;
  14. Patient should be able and willing to comply with study visits and procedures as per protocol;
  15. 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:

  1. Radiological or clinical evidence of metastatic disease documented by imaging or clinical examination performed during screening period;
  2. Has received capecitabine or other ICI than pembrolizumab in the NAC regimen;
  3. 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;
  4. Presents a contraindication to continue pembrolizumab treatment as per respective SmPC including known hypersensitivity;
  5. Previous immune-related adverse event of any grade due to pembrolizumab that led to permanent discontinuation of pembrolizumab;
  6. Presents a contraindication to capecitabine treatment as per SmPC (See EMA website for most recent edition of SmPC);
  7. Complete DPD (Dihydropyrimidine Dehydrogenase) deficiency (a systematic screening of DPD deficiency must be performed);
  8. Patient with active infection ;
  9. Patients with history of uncontrolled or symptomatic cardiac disease ;
  10. Patients having received brivudine within 4 weeks prior to inclusion;

  11. 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;
  12. Pregnant women or women who are breast-feeding;
  13. Patients unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial, social, or psychological reasons;
  14. Persons deprived of their liberty or under protective custody or guardianship;

  15. 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:

  1. Patient information prior to study entry and non-opposition to data collection
  2. Subject ≥18 years of age ;

  3. Histologically proven TNBC defined as follows:

    1. HER2 negativity (ASCO/CAP criteria)
    2. AND less than 10% of cells stained by immunohistochemistry (IHC) for ER and PgR;
  4. 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);
  5. Complete resection of the breast tumor(s) (and of any invaded lymph node);
  6. No complete pathological response, defined as RCB Class I, II or III (per local assessment);
  7. 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:

  1. Radiological or clinical evidence of metastatic disease documented by imaging or clinical examination after surgery.
  2. Has received capecitabine or other ICI than pembrolizumab in the NAC regimen;
  3. 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;
  4. Any investigational anticancer therapy (chemotherapy, immunotherapy, biologic for cancer treatment) other than pembrolizumab only as adjuvant treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental arm : Pembrolizumab and capecitabine
  • 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.
Drug: Pembrolizumab injection
On Day 1 of each cycle for a total of 9 cycles; intravenous (IV) infusion
Other Names:
  • KEYTRUDA®
Drug: Capecitabine tablets
1250 mg/m² BID, on days 1-14 of each 21-day cycle; 8 cycles Dose reduction at 825 mg/m² BID during radiotherapy if indicated
Other Names:
  • Biogaran Capecitabine
Radiation: Local radiotherapy
Local radiotherapy will be performed as per standard practice if indicated.
Other: Standard of care (SOC) treated external cohort
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.
Drug: Pembrolizumab injection
On Day 1 of each cycle for a total of 9 cycles; intravenous (IV) infusion
Other Names:
  • KEYTRUDA®
Radiation: Local radiotherapy
Local radiotherapy will be performed as per standard practice if indicated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
2-year Invasive Disease-free survival (iDFS)
Time Frame: 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.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: 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.
From inclusion to death of any cause, up to 3.5 years.
Distant disease-free survival (DDFS)
Time Frame: 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.
Throughout study completion, up to 3.5 years.
Efficacy (iDFS, OS and DDFS)
Time Frame: 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 .
Throughout study completion, up to 3.5 years.
Acute and late toxicity during the study
Time Frame: 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.
Throughout study completion, up to 3.5 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UNICANCER

Investigators

  • Principal Investigator: Delphine LOIRAT, MD PhD, Institut Curie Paris
  • Principal Investigator: Jean-Yves PIERGA, MD, Institut Curie Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 11, 2025

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

August 1, 2028

Study Registration Dates

First Submitted

July 25, 2023

First Submitted That Met QC Criteria

July 25, 2023

First Posted (Actual)

August 3, 2023

Study Record Updates

Last Update Posted (Actual)

November 17, 2025

Last Update Submitted That Met QC Criteria

November 14, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UC-BCG-2211
  • 2023-505291-30-01 (Other Identifier: EU CT number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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