Efficacy and Safety of Estracyt® in Metastatic Breast Cancer

• Status: Withdrawn
• Trial end date: 2020-01-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Universitaire de Besancon
• Treatments: Estramustine

Criteria

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