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

Efficacy and Safety of Estracyt® in Metastatic Breast Cancer Hormonal Estrogen Receptor (HER 2) Negative, Hormone Receptor (HR) Positive.

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

Study Overview

• Status: Withdrawn
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Estramustine; Drug: standard practice

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 Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Besançon, France, 25030
    • Centre hospitalier régional universitaire

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Estramustine; 560 mg per day	Drug: Estramustine; Other Names: estracyt, estramustine phosphate
Active Comparator: Standard practice center; Standard treatment center choice. Excepted: anthracyclines, taxanes, capecitabine and eribulin	Drug: standard practice; standard practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of the alive patients without progress of the disease	3 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (Anticipated): January 1, 2020
• Study Completion (Anticipated): January 1, 2020

Study Registration Dates

• First Submitted: July 29, 2016
• First Submitted That Met QC Criteria: August 1, 2016
• First Posted (Estimate): August 2, 2016

Study Record Updates

• Last Update Posted (Actual): November 18, 2019
• Last Update Submitted That Met QC Criteria: November 15, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Hormonal; Antineoplastic Agents, Alkylating; Alkylating Agents; Estramustine
• Other Study ID Numbers: P/2015/269

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: The Committee shall meet twice a year

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No