Efficacy and Safety of Estracyt® in Metastatic Breast Cancer

Phase 2

Withdrawn

• Conditions: Breast Cancer
• Interventions: Drug: Estramustine; Drug: standard practice

• Registration Number: NCT02853071
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2016-07-29
• Study First Submitted QC: 2016-08-01
• Study First Posted: 2016-08-02
• Study Start: 2017-01
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-15
• Last Update Posted: 2019-11-18
• Primary Completion: 2020-01
• Study Completion: 2020-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Estramustine	Estramustine	560 mg per day
Standard practice center	standard practice	Standard treatment center choice. Excepted: anthracyclines, taxanes, capecitabine and eribulin

Primary Outcome Measures

Name	Time	Method
Proportion of the alive patients without progress of the disease	3 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Centre Hospitalier Régional Universitaire; 🇫🇷 Besançon, France