Study Evaluating Impact of IL-7 on CD4 Lymphopenia, Risks of Severe Haematological Toxicity and Tumor Progression in Metastatic Breast Cancer Patients

PHASE2CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

June 30, 2011

Primary Completion Date

September 30, 2013

Study Completion Date

June 30, 2014

Conditions
Metastatic Breast Cancer
Interventions
DRUG

placebo

Placebo before the 1st (D0, D7, D14)and during the 3rd CT cycle (D57, D64, D71)

DRUG

interleukin 7

patients will receive an induction cycle of CYT107 (10µg/kg/week subcutaneously for 3 weeks) before the 1st CT cycle (D0, D7, D14) and the placebo during the 3rd CT cycle (D57, D64, D71)

DRUG

interleukin 7

patients will receive the placebo before the 1st CT cycle (D0, D7, D14) and a delayed treatment with CYT107 (10µg/kg/week subcutaneously for 3 weeks) during the 3rd CT cycle (D57, D64, D71)

DRUG

interleukin 7

patients will receive an induction cycle of CYT107 (10µg/kg/week subcutaneously for 3 weeks) before the 1st CT cycle (D0, D7, D14) and a maintenance cycle of IL-7 (10µg/kg/week subcutaneously for 3 weeks) during the 3rd CT cycle (D57, D64, D71)

Trial Locations (3)

75005

Institut Curie, Paris

Unknown

Centre Leon Berard, Lyon

Institut Gustave Roussy, Villejuif

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Ministry of Health, France

OTHER_GOV

collaborator

Cytheris, Inc.

INDUSTRY

lead

Centre Leon Berard

OTHER