Efficacy and Safety of Estracyt® in Metastatic Breast Cancer

NCT ID: NCT02853071

Last Updated: 2019-11-18

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2020-01-31

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Estramustine

560 mg per day

Group Type: EXPERIMENTAL

Estramustine

Intervention Type: DRUG

Standard practice center

Standard treatment center choice.

Excepted: anthracyclines, taxanes, capecitabine and eribulin

Group Type: ACTIVE_COMPARATOR

standard practice

Intervention Type: DRUG

standard practice

Interventions

Estramustine

Intervention Type: DRUG

standard practice

standard practice

Intervention Type: DRUG

Other Intervention Names

estracyt, estramustine phosphate

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre Hospitalier Régional Universitaire

Besançon, , France

Countries

France

Other Identifiers

P/2015/269

Identifier Type: -

Identifier Source: org_study_id