Efficacy and Safety of Estracyt® in Metastatic Breast Cancer (BEST)

Centre Hospitalier Universitaire de Besancon

Status and phase: Withdrawn; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Estramustine; Drug: standard practice

Study type: Interventional

Funder types: Other

Identifiers

NCT02853071

P/2015/269

Details and patient eligibility

About

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

Full description

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.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Estramustine

Experimental group

Description:

560 mg per day

Treatment:

Drug: Estramustine

Standard practice center

Active Comparator group

Description:

Standard treatment center choice. Excepted: anthracyclines, taxanes, capecitabine and eribulin

Treatment:

Drug: standard practice