Actively Recruiting
Capecitabine Plus Pembrolizumab in Patients With Triple Negative Breast Cancer After Chemo-immunotherapy and Surgery
Led by UNICANCER · Updated on 2025-11-17
220
Participants Needed
20
Research Sites
177 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Capecitabine Plus Pembrolizumab in Patients With Triple Negative Breast Cancer After Chemo-immunotherapy and Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must provide written informed consent
- Age 18 years or older at consent
- Histologically confirmed triple negative breast cancer with HER2 negativity and less than 10% ER and PgR staining
- Previously treated with at least 6 cycles of neoadjuvant immunochemotherapy including pembrolizumab and anthracyclines and/or taxanes
- Complete surgical removal of breast tumor and any involved lymph nodes
- Residual disease present after neoadjuvant chemotherapy (no complete pathological response, defined as RCB Class I, II, or III)
- Available tumor tissue from surgery for analysis
- Eastern Cooperative Oncology Group (ECOG) performance status less than 2
- Adequate organ and bone marrow function based on recent laboratory tests
- Resolution of acute toxicities from prior treatments to at least grade 1 except alopecia and controlled grade 2 endocrinopathies
- At least 2 weeks since breast surgery and 3 weeks since last pembrolizumab dose before starting study treatment
- Negative pregnancy test within 7 days before starting treatment for women of child-bearing potential
- Agreement to use effective contraception during study and for 6 months after last dose
- Ability and willingness to comply with study procedures and visits
- Affiliation with a social security system or equivalent
You will not qualify if you...
- Evidence of metastatic disease by imaging or clinical exam
- Prior use of capecitabine or immune checkpoint inhibitors other than pembrolizumab in neoadjuvant chemotherapy
- Known additional malignancies except certain skin cancers or treated cancers with no disease for 2 years
- Contraindications to pembrolizumab or capecitabine including known hypersensitivity
- Immune-related adverse events from pembrolizumab leading to permanent discontinuation
- Complete deficiency of DPD enzyme
- Active infection
- History of uncontrolled or symptomatic heart disease
- Use of brivudine within 4 weeks prior to study
- Concurrent use of other investigational anticancer therapies or chemotherapy/immunotherapy not specified in protocol
- Pregnant or breastfeeding women
- Inability or unwillingness to comply with medical follow-up due to social, geographic, or psychological reasons
- Persons under legal guardianship or deprived of liberty
- Participation in another therapeutic trial within 30 days prior to randomization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 20 locations
1
CHU Amiens Picardie_Site Sud
Amiens, France, 80054
Actively Recruiting
2
Institut Sainte Catherine
Avignon, France, 84918
Actively Recruiting
3
Centre Hospitalier de la Côte Basque
Bayonne, France, 64109
Actively Recruiting
4
CHU Jean Minoz
Besançon, France
Actively Recruiting
5
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, France, 33077
Actively Recruiting
6
Centre François Baclesse
Caen, France, 14000
Actively Recruiting
7
Centre Georges-François Leclerc
Dijon, France
Actively Recruiting
8
CHD Vendee
La Roche-sur-Yon, France
Actively Recruiting
9
Centre Oscar Lambret
Lille, France
Actively Recruiting
10
Centre Léon Bérard
Lyon, France, 69008
Actively Recruiting
11
Institut Paoli-Calmettes
Marseille, France, 13009
Actively Recruiting
12
Institut Curie
Paris, France, 75005
Actively Recruiting
13
Clinique de La Croix du sud
Quint-Fonsegrives, France, 31130
Actively Recruiting
14
Institut Godinot
Reims, France, 51100
Actively Recruiting
15
Institut Curie
Saint-Cloud, France, 92210
Actively Recruiting
16
Clinique Mutualiste de l'Estuaire
Saint-Nazaire, France
Actively Recruiting
17
Centre Paul Strauss
Strasbourg, France
Actively Recruiting
18
Institut Claudius Regaud, IUCT Oncopole
Toulouse, France
Actively Recruiting
19
CHU Bretonneau
Tours, France, 37000
Actively Recruiting
20
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, France, 54519
Actively Recruiting
Research Team
T
Telma ROQUE, PhD
CONTACT
S
Sylvie Mijonnet, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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