Efficacy and Safety of Estracyt® in Metastatic Breast Cancer

Study Overview
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Brief Summary
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This study evaluates efficacy, safety and quality of life in patients affected by metastatic breast cancer RH+/ HER2- and treated by estramustine phosphate.

Detailed Description
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For patients affected by metastatic breast cancer RH+/HER2-, the conventional treatment is hormonotherapy. But, when patients don't react no recommendations exist. Estramustine phosphate is currently prescribed for prostate cancer. The estramustine phosphate is an active anti-tumoral agent by oral route, associating a nitrogenous mustard with the estradiol, it settles on membrane receptor and the cytotoxic component acts essentially by dismantling microtubules inhibiting the mitosis. Estramustine could be a therapeutic option when currently therapy are exhausted for patients reactive to hormonotherapy previous lines or chemotherapy.

Official Title
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Efficacy and Safety of Estracyt® in Metastatic Breast Cancer Hormonal Estrogen Receptor (HER 2) Negative, Hormone Receptor (HR) Positive.

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Estramustine
* Drug: standard practice


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Metastatic breast cancer HER2-/RH+ Progression after hormonotherapy Treated by taxanes, anthracyclines, capecitabine and eribulin Treated by everolimus ECOG ≤ 2 Hematological Function: neutrophiles ≥ 1,5 x 109 / L, hemoglobin ≥ 9 g / dL, plaques ≥ 100 x 109 / L Hepatic function: albumin ≥ 2,5 g / dl, bilirubin serum ≤ 2 x N (superior border of the standard) (unless disease of Gilbert), transaminases ≥ 3 x N Renal Function: serum creatinine ≤ 1,5 mg / dL or clearance of the creatinine ≥ 40 mL / min Estimated Life expectancy ≥ 3 months Exclusion Criteria: Hypersensitivity known about one of the constituents of the estramustine phosphates Preliminary Treatment by estramustine phosphates Brain Metastases Patients not being under effective contraception Minor, pregnant or lactating Patients Patients not previously treated by everolimus Transaminases > 3xN Other concomitant anticancer treatment less than 1 month before the inclusion Digestive function: malabsorption History of other cancer in the previous 5 years (other than squamous-cell epithelioma or totally resected in situ carcinoma) Active Thrombo-phlebitis Risk thromboembolic known, Unchecked cardiovascular Pathology Grave hepatic Affection

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Estramustine<br>560 mg per day | Drug: Estramustine<br> <br> * Other names: estracyt, estramustine phosphate;|
| Active Comparator: Standard practice center<br>Standard treatment center choice. Excepted: anthracyclines, taxanes, capecitabine and eribulin | Drug: standard practice<br>* standard practice<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of the alive patients without progress of the disease |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 items (EORTC QLQ-C30) | 18 months | 
| progression-free survival |  | 18 months | 
| overall survival |  | 18 months |