Durvalumab and Endocrine Therapy in ER+/Her2- Breast Cancer After CD8+ Infiltration Effective Immune-Attractant Exposure

PHASE2CompletedINTERVENTIONAL
Enrollment

61

Participants

Timeline

Start Date

February 15, 2017

Primary Completion Date

July 15, 2019

Study Completion Date

August 28, 2020

Conditions
Breast CancerEstrogen Receptor Positive TumorMenopauseHormone Antagonist
Interventions
DRUG

Immune-attractant

The first cohort patients will receive tremelimumab (3 mg/kg, single infusion) as immune-attractants combined with exemestane (25 mg daily).

DRUG

Durvalumab

Durvalumab (lymphocyte activation) will be administrated at a dose of 1500 mg Q4W (equivalent to 20 mg/kg Q4W) IV, combined with exemestane (25 mg daily), for six months

PROCEDURE

Biopsy

After three weeks (+/- 3 days) of immune-attractants, a tumor biopsy will be done. Patients who present \>10% CD8+ cells in the tumor after 3 weeks will receive the Durvalumab

Trial Locations (29)

13009

Institut Paoli Calmettes, Marseille

21000

Centre George François Leclerc, Dijon

31059

Institut Claudius Regaud, Toulouse

33000

Institut Bergonié, Bordeaux

37044

CHU Bretonneau - Centre Henry Kaplan, Tours

38028

Institut Daniel Hollard Groupe Hôspitalier, Grenoble

46000

Centre Hospitalier de Cahors, Cahors

49300

Centre Hôspitalier de Cholet, Cholet

51726

Institut Jean Godinot, Reims

56100

Centre Hospitalier Bretagne Sud, Lorient

59020

Centre Oscar Lambret, Lille

64109

Centre Hospitalier cote Basque, Bayonne

66000

Centre Hospitalier Perpignan, Perpignan

67065

Centre Paul Strauss, Strasbourg

69008

Centre Léon Bérard, Lyon

75005

Institut Curie Site Paris, Paris

75010

Hôpital Saint Louis APHP, Paris

87042

CHU Limoges, Limoges

92210

Institut Curie Hôpital René Huguenin, Saint-Cloud

94800

Gustave Roussy, Villejuif

Unknown

Centre François Baclesse, Caen

ICO Badalona, Badalona

Hospital Clinic Barcelona, Barcelona

HU Vall Hebron, Barcelona

HU Arnau de Vilanova, Lleida

CIO Clara Campal, Madrid

HU Ramon y Cajal, Madrid

Hospital Clínico Universitario de Valencia, Valencia

Sahlgrenska University Hospital, Gothenburg

Sponsors
All Listed Sponsors
collaborator

Breast International Group

OTHER

lead

UNICANCER

OTHER

NCT02997995 - Durvalumab and Endocrine Therapy in ER+/Her2- Breast Cancer After CD8+ Infiltration Effective Immune-Attractant Exposure | Biotech Hunter | Biotech Hunter