Despite advances in early detection and treatment strategy, about 25 to 40% of patients treated for breast cancer develop metastasis. Some patients are in a therapeutic impasse situation. It is therefore necessary to consider all possible options. The Estramustine showed encouraging results in the treatment of metastatic breast cancer. Given the clinical data, the answer rate of Estramustine and its impact on progression free survival deserve to be studied in earlier clinical situation. This Phase II study evaluated the efficacy of Estramustine in women with breast cancer and metastates, already treated with aromatase inhibitors and for whom this treatment has failed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
140mg/4 caps/day
20mg/day
Institut Sainte Catherine
Avignon, France
CHU Besançon-Jean Minjoz
Besançon, France
Polyclinique de Blois
Blois, France
CHU Avicenne
Bobigny, France
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, France
CHRU Brest
Brest, France
Centre O. Lambret
Lille, France
CLCC Léon Bérard
Lyon, France
Hôpital Privé Clairval
Marseille, France
CHBM Site du Mittan
Montbéliard, France
...and 11 more locations
Progression-free survival after a 6- month monotherapy with Estramustine in patients with HER2-/RH+ breast cancer progressing
proportion of patients in progression-free survival (PFS) after a 6-month treatment is defined as the duration of objective response or stabilisation of the disease according to the Recist criteria. The following events shall be considered as progressive : * Relapse * Treatment intolerance leading to stop the treatment * Death
Time frame: up to 6 months
Risks of thrombosis
risks of thrombosis assessed by the analysis of biomarkers (D-Dimer, prothrombin fragment 1+2, von Willebrand factor, fibrinogen, Chain Reaction Protein)
Time frame: up to 6 months
Clinical benefit of estramustine
clinical benefit of estramustine assessed by RECIST criteria
Time frame: 1 year
Correlation between the answer rate and biomarkers
answer rate (RECIST criteria) and level of biomarkers (Lactate déshydrogénase, Antigène carcino-embryonnaire and Cancer antigène 15-3)
Time frame: 1 year
Tolerance of estramustine treatment
Toxicity (Common Terminology Criteria for Adverse Events)
Time frame: 1 year
Tolerance of tamoxifen treatments
Toxicity (Common Terminology Criteria for Adverse Events)
Time frame: 1 year
Proportion of patients developing thromboembolic events
proportion of patients developing thromboembolic events assessed in the 2 groups every month during the one-year patient follow-up
Time frame: 1 year
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