Informations générales (source: ClinicalTrials.gov)
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
Interventional
Phase 2
UNICANCER (Voir sur ClinicalTrials)
mars 2025
août 2028
02 décembre 2025
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC RENE HUGUENIN INSTITUT CURIE | LOIRAT, MD | Contact (sur clinicalTrials) | |||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Hospitalier de la Côte Basque - 64109 - Bayonne 3034475 - France | Thomas GRELLETY, MD | Contact (sur clinicalTrials) | |||
| Centre Léon Bérard - 69008 - Lyon 2996944 - France | Olivier TREDAN, MD | Contact (sur clinicalTrials) | |||
| Centre Paul Strauss - Strasbourg 2973783 - France | Thierry PETIT, MD | Contact (sur clinicalTrials) | |||
| CHU Jean Minoz - Besançon 3033123 - France | Laura MANSI, MD | Contact (sur clinicalTrials) | |||
| Clinique Mutualiste de l'Estuaire - Saint-Nazaire 2977921 - France | Tifenne L'HARIDON, MD | Contact (sur clinicalTrials) | |||
| Institut Sainte Catherine - 84918 - Avignon 3035681 - France | Julien GRENIER | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre François Baclesse - 14000 - Caen 3029241 - France | George EMILE, MD | Contact (sur clinicalTrials) | |||
| Centre Georges-François Leclerc - Dijon 3021372 - France | Sylvain LADOIRE, MD | Contact (sur clinicalTrials) | |||
| Centre Oscar Lambret - Lille 2998324 - France | Claire CHEYMOL, MD | Contact (sur clinicalTrials) | |||
| CHD Vendee - La Roche-sur-Yon 3006767 - France | Camille GOISLARD DE MONSABERT, MD | Contact (sur clinicalTrials) | |||
| CHU Amiens Picardie_Site Sud - 80054 - Amiens 3037854 - France | Aurélie MOREIRA, MD | Contact (sur clinicalTrials) | |||
| CHU Bretonneau - 37000 - Tours 2972191 - France | Marie-Agnès BY, MD | Contact (sur clinicalTrials) | |||
| Clinique de La Croix du sud - 31130 - Quint-Fonsegrives 2984655 - France | Francesco RICCI, MD | Contact (sur clinicalTrials) | |||
| Institut Claudius Regaud, IUCT Oncopole - Toulouse 2972315 - France | MD | Contact (sur clinicalTrials) | |||
| Institut Curie - 75005 - Paris 2988507 - France | Delphine LOIRAT, MD | Contact (sur clinicalTrials) | |||
| Institut de Cancérologie de Lorraine - 54519 - Vandœuvre-lès-Nancy 2970797 - France | Anne KIEFFER, MD | Contact (sur clinicalTrials) | |||
| Institut Godinot - 51100 - Reims 2984114 - France | Christelle JOUANNAUD, MD | Contact (sur clinicalTrials) | |||
| Institut Paoli-Calmettes - 13009 - Marseille 2995469 - France | Alexandre DE NONNEVILLE, MD | Contact (sur clinicalTrials) | |||
| Polyclinique Bordeaux Nord Aquitaine - 33077 - Bordeaux 3031582 - France | Nadine DOHOLLOU, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
• 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.
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.