Addition of Aromatase at the Navelbine in Pretreated Metastatic Breast Cancer.

Sponsor
ARCAGY/ GINECO GROUP
Study ID
NCT02585388
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
FEMALE
Age
50 Years - 95 Years
Healthy Volunteers
Not accepted

Interventions

  • Vinorelbine — DRUG
    Vinorelbine metronomic at 50 mg (1 tablet at 20 mg and 1 tablet at 30mg),per oral, 3 times per week. One dose level reduction is authorized at 30 mg per day.when stopping over 3 consecutive weeks due to toxicity, treatment should be permanently discontinued
  • Letrozole — DRUG
    Lestrozole at 2,5 mg every day , per oral
  • Anastrozole — DRUG
    Anastrozole at 1 mg every day, per oral

Study Details

The CHEOPS study aims to confirm the clinical benefit of a combination of an anti-aromatase and metronomic chemotherapy treatment

Key Dates

Start date
Oct 23, 2015
Status verified
Sep 2023
Primary completion
May 15, 2017
Completion
May 15, 2017

Study Design

Enrollment
120 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Vinorelbine
    Vinorelbine (metronomic) alone 3 times per week ( mondays, wednesdays, Fridays or Thursdays, Tuesdays, Saturdays) at 50 mg per day, taken orally until progression of disease or toxicity.
  • Experimental: Vinorelbine+Anastrozole or Letrozole
    Vinorelbine metronomic 3 times per week (mondays, wednesdays, Fridays or Thursdays,Tuesdays, Saturdays) at 50 mg per day, taken orally until progression of disease or toxicity. And: Letrozole 2,5 mg every day or Anastrozole 1 mg every day. Until progression of disease or toxicity

Primary Outcome Measure

Progression free survival (PFS) [ Time Frame: up to 6 months ]

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