Efficacy and Safety of Estracyt® in Metastatic Breast Cancer

NCT02853071 | Withdrawn Phase 2 DMC

• 1 other identifier: P/2015/269
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Proportion of the alive patients without progress of the disease

  3 months

Secondary Outcomes (3)

• quality of life

  18 months

• progression-free survival

  18 months

• overall survival

  18 months

Study Arms (2)

Estramustine

EXPERIMENTAL

560 mg per day

Drug: Estramustine

Standard practice center

ACTIVE COMPARATOR

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

Drug: standard practice

Interventions

Estramustine DRUG

Also known as: estracyt, estramustine phosphate

Estramustine

standard practice DRUG

standard practice

Standard practice center

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Study Sites (1)

Centre Hospitalier Régional Universitaire

Besançon, 25030, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Estramustine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2016
• First Posted: August 2, 2016
• Study Start: January 1, 2017
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: November 18, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will share

Locations

FR (1)