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Triple Negative Breast NeoplasmsPhase 2CAPPANCT05973864

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

A Phase 2 study testing Pembrolizumab injection, Capecitabine tablets and Local radiotherapy in people with Triple Negative Breast Neoplasms, run by UNICANCER at 20 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Triple Negative Breast Neoplasms
What is being tested?
Pembrolizumab injection, Capecitabine tablets and Local radiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
220 participants
Where
20 sitesFrance
Study dates
11 Mar 2025to Aug 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
Show all 55Show fewer
  • 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.

Who cannot join

None listed.

Trial locations and contacts

20 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Telma ROQUE, PhD contact

+33 (0) 1 80 50 12 92

cappa@unicancer.fr

Sylvie Mijonnet, PhD contact

+33 (0) 1 44 23 04 65

s-mijonnet@unicancer.fr

20 sites in 1 country

France20 sites, 20 recruiting

  • CHU Amiens Picardie_Site Sud

    Amiens, 80054

    Aurélie MOREIRA, MD, Moreira.Aurelie@chu-amiens.fr

    Aurélie MOREIRA, MD

    Recruiting

  • Institut Sainte Catherine

    Avignon, 84918

    Julien GRENIER, j.grenier@isc84.org

    Julien GRENIER, MD

    Recruiting

  • Centre Hospitalier de la Côte Basque

    Bayonne, 64109

    Thomas GRELLETY, MD, +335 59 44 37 62, tgrellety@ch-cotebasque.fr

    Thomas GRELLETY, MD

    Recruiting

  • CHU Jean Minoz

    Besançon

    Laura MANSI, MD, lmansi@chu-besancon.fr

    Laura MANSI, MD

    Recruiting

  • Polyclinique Bordeaux Nord Aquitaine

    Bordeaux, 33077

    Nadine DOHOLLOU, MD, n.dohollou@gor.bordeauxnord.com

    Nadine DOHOLLOU, MD

    Recruiting

  • Centre François Baclesse

    Caen, 14000

    George EMILE, MD, g.emile@baclesse.unicancer.fr

    Georges EMILE, MD

    Recruiting

  • Centre Georges-François Leclerc

    Dijon

    Sylvain LADOIRE, MD, sladoire@cgfl.fr

    Sylvain LADOIRE, MD

    Recruiting

  • CHD Vendee

    La Roche-sur-Yon

    Camille GOISLARD DE MONSABERT, MD, +332 51 44 61 73, camille.goislard-demonsabert@ght85.fr

    Camille GOISLARD DE MONSABERT, MD

    Recruiting

  • Centre Oscar Lambret

    Lille

    Claire CHEYMOL, MD, c-cheymol@o-lambret.fr

    Claire CHEYMOL, MD

    Recruiting

  • Centre Léon Bérard

    Lyon, 69008

    Olivier TREDAN, MD, olivier.tredan@lyon.unicancer.fr

    Olivier TREDAN, MD

    Recruiting

  • Institut Paoli-Calmettes

    Marseille, 13009

    Alexandre DE NONNEVILLE, MD, denonnevillea@ipc.unicancer.fr

    Alexandre DE NONNEVILLE, MD

    Recruiting

  • Institut Curie

    Paris, 75005

    Delphine LOIRAT, MD, +331 56 24 55 00, delphine.loirat@curie.fr

    Delphine LOIRAT, MD

    Recruiting

  • Clinique de La Croix du sud

    Quint-Fonsegrives, 31130

    Francesco RICCI, MD, +335 32 02 72 44, Ricci.onco@outlook.com

    Francesco RICCI, MD

    Recruiting

  • Institut Godinot

    Reims, 51100

    Christelle JOUANNAUD, MD, +333 26 50 43 83, christelle.jouannaud@reims.unicancer.fr

    Christelle JOUANNAUD, MD

    Recruiting

  • Institut Curie

    Saint-Cloud, 92210

    LOIRAT, MD, +33147 11 15 15, delphine.loirat@curie.fr

    Delphine LOIRAT, MD

    Recruiting

  • Clinique Mutualiste de l'Estuaire

    Saint-Nazaire

    Tifenne L'HARIDON, MD, tifenn.lharidon@hospigrandouest.fr

    Tiffen L'HARIDON, MD

    Recruiting

  • Centre Paul Strauss

    Strasbourg

    Thierry PETIT, MD, t.petit@icans.eu

    Thierry PETIT, MD

    Recruiting

  • Institut Claudius Regaud, IUCT Oncopole

    Toulouse

    MD, +335 31 15 51 22, Dalenc.Florence@iuct-oncopole.fr

    Florence DALENC, MD

    Recruiting

  • CHU Bretonneau

    Tours, 37000

    Marie-Agnès BY, MD, MA.BY@chu-tours.fr

    Marie-Agnès BY, MD

    Recruiting

  • Institut de Cancérologie de Lorraine

    Vandœuvre-lès-Nancy, 54519

    Anne KIEFFER, MD, +333 83 59 85 64, a.kieffer@nancy.unicancer.fr

    Anne KIEFFER, MD

    Recruiting

Other trials in France

About this study

Official title: 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.

Read the 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.

Being tested
Pembrolizumab injection, Capecitabine tablets, Local radiotherapy
Medical subject headings
Triple Negative Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pembrolizumab injectionDrug

    Also called KEYTRUDA®

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

  • Capecitabine tabletsDrug

    Also called Biogaran Capecitabine

    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

  • Local radiotherapyRadiation

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

Study groups in NCT05973864
Study groupRoleWhat they receive
Experimental arm : Pembrolizumab and capecitabineExperimental* 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.
Receives: Drug: Pembrolizumab injection; Drug: Capecitabine tablets; Radiation: Local radiotherapy
Standard of care (SOC) treated external cohortOtherA 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.
Receives: Drug: Pembrolizumab injection; Radiation: Local radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 2 years

Secondary outcomes (4)

  1. Overall survival (OS)

    The overall survival is the length of time from randomization that patients enrolled in the study are still alive.

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

  2. Distant disease-free survival (DDFS)

    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.

    Measured: Throughout study completion, up to 3.5 years.

  3. Efficacy (iDFS, OS and DDFS)

    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 .

    Measured: Throughout study completion, up to 3.5 years.

  4. Acute and late toxicity during the study

    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.

    Measured: Throughout study completion, up to 3.5 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2023
  2. Study start11 Mar 2025
  3. Primary completionAug 2028 (estimated)
  4. Study completionAug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
220 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05973864
Sponsor's protocol ID
UC-BCG-2211
Other IDs
2023-505291-30-01, 2023
Acronym
CAPPA
Status last verified
Oct 2025
First submitted
25 Jul 2023
Last updated
17 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pembrolizumab injection, Capecitabine tablets and Local radiotherapy in people with Triple Negative Breast Neoplasms, run by UNICANCER at 20 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 55 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Telma ROQUE, PhD (+33 (0) 1 80 50 12 92, cappa@unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

2-year Invasive Disease-free survival (iDFS) (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05973864.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.

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