Pembrolizumab and Chemotherapy Treatment or no Treatment Guided by the Level of TILs in Resected Early-stage TNBC

PHASE2RecruitingINTERVENTIONAL
Enrollment

354

Participants

Timeline

Start Date

December 27, 2024

Primary Completion Date

January 1, 2032

Study Completion Date

January 1, 2032

Conditions
Triple-negative Breast Cancer
Interventions
DRUG

Pembrolizumab 25 mg/ml

"Pembrolizumab drug product is a sterile-filtered liquid and is aseptically filled into single-use vials.~The vials contain 4 mL of sterile solution for IV infusion."

DRUG

Paclitaxel injection

Injectable solution for IV administration. Dose of 80 mg/m² weekly.

Trial Locations (44)

13009

NOT_YET_RECRUITING

Institut Paoli-Calmettes, Marseille

14000

NOT_YET_RECRUITING

Centre François Baclesse, Caen

14004

NOT_YET_RECRUITING

Hospital Universitario Reina Sofia, Córdoba

18016

NOT_YET_RECRUITING

Hospital Universitario Clinico San Cecilio, Granada

21000

NOT_YET_RECRUITING

Centre Georges-François Leclerc, Dijon

22190

NOT_YET_RECRUITING

Hôpital Privé des côtes d'Armor, Plérin

24071

NOT_YET_RECRUITING

Complejo Asistencial Universitario de Leon, León

25198

NOT_YET_RECRUITING

Hu Arnau de Vilanova Lleida, Lleida

28034

NOT_YET_RECRUITING

Hospital Ramon Y Cajal, Madrid

28041

NOT_YET_RECRUITING

Hospital 12 de Octubre, Madrid

29107

RECRUITING

Centre Hospitalier de Cornouaille, Quimper

30029

NOT_YET_RECRUITING

CHU de Nîmes, Nîmes

30120

NOT_YET_RECRUITING

Hospital Clinico Universitario Virgen de La Arrixaca, El Palmar

31059

RECRUITING

Institut Claudius Regaud, Toulouse

31130

NOT_YET_RECRUITING

Clinique La Croix du Sud, Quint-Fonsegrives

33000

NOT_YET_RECRUITING

Institut Bergonié, Bordeaux

33077

NOT_YET_RECRUITING

Polyclinique Bordeaux Nord Aquitaine, Bordeaux

34298

NOT_YET_RECRUITING

Institut régional du Cancer de Montpellier, Montpellier

35000

RECRUITING

Centre Eugène Marquis, Rennes

37000

NOT_YET_RECRUITING

CHU Bretonneau, Tours

41013

NOT_YET_RECRUITING

Hospital Universitario Virgen Del Rocio, Seville

42055

NOT_YET_RECRUITING

CHU de Saint Etienne, Saint-Etienne

43204

NOT_YET_RECRUITING

Hospital Sant Joan de Reus, Reus

44200

NOT_YET_RECRUITING

Hôpital privé du confluent, Nantes

46010

NOT_YET_RECRUITING

Hospital Clínico Valencia, Valencia

51100

NOT_YET_RECRUITING

Institut Godinot, Reims

54519

NOT_YET_RECRUITING

Centre Alexis Vautrin, Vandœuvre-lès-Nancy

61000

RECRUITING

Centre Antoine Lacassagne, Nice

63000

NOT_YET_RECRUITING

Pôle Santé Republique, Clermont-Ferrand

63011

NOT_YET_RECRUITING

Centre Jean Perrin, Clermont-Ferrand

64046

RECRUITING

Centre Hospitalier de Pau, Pau

64109

RECRUITING

Centre Hospitalier de la Côte Basque, Bayonne

69008

RECRUITING

Centre Léon Bérard, Lyon

RECRUITING

Hopital Privé Jean Mermoz, Lyon

80054

NOT_YET_RECRUITING

CHU Amiens Picardie_Site Sud, Amiens

84918

NOT_YET_RECRUITING

Institut Sainte Catherine, Avignon

87042

NOT_YET_RECRUITING

CHU de Limoges, Limoges

92300

NOT_YET_RECRUITING

Hôpital Franco-Britannique-Fondation Cognacq-Jay, Levallois-Perret

94805

RECRUITING

Gustave Roussy, Villejuif

95300

RECRUITING

Hôpital NOVO, Pontoise

08916

NOT_YET_RECRUITING

Ico Badalona, Badalona

08035

NOT_YET_RECRUITING

Hospital Vall D'Hebrón, Barcelona

08908

NOT_YET_RECRUITING

Ico Hospitalet, L'Hospitalet de Llobregat

07120

NOT_YET_RECRUITING

Hospital Universitari Son Espases, Palma de Mallorca

All Listed Sponsors
collaborator

MSD France

INDUSTRY

collaborator

SOLTI Breast Cancer Research Group

OTHER

collaborator

Gustave Roussy, Cancer Campus, Grand Paris

OTHER

collaborator

Vall Hebron Insitut Recerca

NETWORK

lead

UNICANCER

OTHER