The CHEOPS study aims to confirm the clinical benefit of a combination of an anti-aromatase and metronomic chemotherapy treatment
The CHEOPS study aims to confirm the clinical benefit of a combination of an anti-aromatase and metronomic chemotherapy treatment that would have the theoretical advantage of being well tolerated and more effective than chemotherapy alone even after an anti-aromatase therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
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
Lestrozole at 2,5 mg every day , per oral
Anastrozole at 1 mg every day, per oral
Progression free survival (PFS)
Proportion of progression or death
Time frame: up to 6 months
Evaluation of partial and complete response rate by RECIST 1.1
partial and complete response rate by RECIST 1.1 in each arm
Time frame: up to 6 months
duration of response
duration of response is defined as the time from randomization and the disease progression
Time frame: up to 6 months
clinical benefit after 24 weeks of treatment
the clinical benefit is defined by the rate of complete response, by the rate of partial response and by the stability of lesions at 24 weeks according to criteria RECIST 1.1
Time frame: up to 24 weeks
overall survival
the overall survival of patients randomized is defined as the time from randomization and the date of death
Time frame: up to 2 years
Toxicity according to criteria NCI CTAEv4.03
tolerance of the treatment based on AE occurrence according to criteria NCI CTAEv4.03
Time frame: up to 2 years
health-related quality of life
health-related quality of life and symptomatic state will be evaluated by filling a questionnaire by patients
Time frame: up to 2 years
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