Know Cancer

forgot password

Phase 3
18 Years
Open (Enrolling)
Breast Cancer

Thank you

Trial Information

Inclusion Criteria:

- metastatic breast cancer

- objective response or stabilisation after 6 to 8 cycle of a first line chemotherapy

- time period between the end of chemotherapy and randomization < 4 weeks

- age over 18 years

- Performance status (OMS) < 2.

- Life expectancy > 3 months

- Biological criteria before randomization: Neutrophiles > 1.5 x 109 G/L; Pl. > 100 x
109 G/L; Hb > 10 g/dl; Creatininemia < 1,5 UNL; Bili. < 2 UNL; Transaminases < 2,5
UNL; Alcalines Phosphatases < 2,5 UNL

- Signed written informed consent

Exclusion Criteria:

- Metastatic breast cancer having received more than one chemotherapy line.

- Tumor progression under chemotherapy

- Free interval between primary tumor and metastases > 5 years, with estrogen receptors
and without visceral metastases

- Free interval between primary tumor and metastases < 18 months after adjuvant
chemotherapy if first lime chemotherapy only led to a tumor stabilization

- Concomitant hormonotherapy

- Other cancer

- Symptomatic brain metastases

- Any uncontrolled severe disease except breast cancer (especially cardiac failure with
LVEF < 50% or coronary insufficiency

- Psychiatric disorder

- Other concomitant trial

- Male patient

- Pregnancy and breast-feeding (effective contraception is mandatory in the case of
women of child-bearing potential)

- History of high dose chemotherapy with bone marrow transplantation

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Jean-Francois Berdah, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:



France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:




Start Date:

Completion Date:

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms