NCT05973864

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for phase_2

Timeline
27mo left

Started Mar 2025

Typical duration for phase_2

Geographic Reach
1 country

20 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress34%
Mar 2025Aug 2028

First Submitted

Initial submission to the registry

July 25, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 3, 2023

Completed
1.6 years until next milestone

Study Start

First participant enrolled

March 11, 2025

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2028

Last Updated

November 17, 2025

Status Verified

October 1, 2025

Enrollment Period

3.4 years

First QC Date

July 25, 2023

Last Update Submit

November 14, 2025

Conditions

Triple Negative Breast Neoplasms

Outcome Measures

Primary Outcomes (1)

  • 2-year Invasive Disease-free survival (iDFS)

    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 Outcomes (4)

  • Overall survival (OS)

    From inclusion to death of any cause, up to 3.5 years.

  • Distant disease-free survival (DDFS)

    Throughout study completion, up to 3.5 years.

  • Efficacy (iDFS, OS and DDFS)

    Throughout study completion, up to 3.5 years.

  • Acute and late toxicity during the study

    Throughout study completion, up to 3.5 years.

Study Arms (2)

Experimental arm : Pembrolizumab and capecitabine

EXPERIMENTAL

* 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 injectionDrug: Capecitabine tabletsRadiation: Local radiotherapy

Standard of care (SOC) treated external cohort

OTHER

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 injectionRadiation: Local radiotherapy

Interventions

Pembrolizumab injectionDRUG

On Day 1 of each cycle for a total of 9 cycles; intravenous (IV) infusion

Also known as: KEYTRUDA®
Experimental arm : Pembrolizumab and capecitabineStandard of care (SOC) treated external cohort
Capecitabine tabletsDRUG

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

Also known as: Biogaran Capecitabine
Experimental arm : Pembrolizumab and capecitabine
Local radiotherapyRADIATION

Local radiotherapy will be performed as per standard practice if indicated.

Experimental arm : Pembrolizumab and capecitabineStandard of care (SOC) treated external cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;
  • 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;
  • 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;
  • +28 more criteria

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

CHU Amiens Picardie_Site Sud

Amiens, 80054, France

RECRUITING

Institut Sainte Catherine

Avignon, 84918, France

RECRUITING

Centre Hospitalier de la Côte Basque

Bayonne, 64109, France

RECRUITING

CHU Jean Minoz

Besançon, France

RECRUITING

Polyclinique Bordeaux Nord Aquitaine

Bordeaux, 33077, France

RECRUITING

Centre François Baclesse

Caen, 14000, France

RECRUITING

Centre Georges-François Leclerc

Dijon, France

RECRUITING

CHD Vendee

La Roche-sur-Yon, France

RECRUITING

Centre Oscar Lambret

Lille, France

RECRUITING

Centre Léon Bérard

Lyon, 69008, France

RECRUITING

Institut Paoli-Calmettes

Marseille, 13009, France

RECRUITING

Institut Curie

Paris, 75005, France

RECRUITING

Clinique de La Croix du sud

Quint-Fonsegrives, 31130, France

RECRUITING

Institut Godinot

Reims, 51100, France

RECRUITING

Institut Curie

Saint-Cloud, 92210, France

RECRUITING

Clinique Mutualiste de l'Estuaire

Saint-Nazaire, France

RECRUITING

Centre Paul Strauss

Strasbourg, France

RECRUITING

Institut Claudius Regaud, IUCT Oncopole

Toulouse, France

RECRUITING

CHU Bretonneau

Tours, 37000, France

RECRUITING

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, 54519, France

RECRUITING

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

pembrolizumabCapecitabine

Condition Hierarchy (Ancestors)

Breast NeoplasmsNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Delphine LOIRAT, MD PhD

    Institut Curie Paris

    PRINCIPAL INVESTIGATOR

  • Jean-Yves PIERGA, MD

    Institut Curie Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Telma ROQUE, PhD

CONTACT

+33 (0) 1 80 50 12 92cappa@unicancer.fr

Sylvie Mijonnet, PhD

CONTACT

+33 (0) 1 44 23 04 65s-mijonnet@unicancer.fr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2023

First Posted

August 3, 2023

Study Start

March 11, 2025

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

August 1, 2028

Last Updated

November 17, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

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

Locations

FR(20)