Efficacy and Safety of Estracyt® in Metastatic Breast Cancer (BEST)
November 15, 2019 updated by: Centre Hospitalier Universitaire de Besancon
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Withdrawn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
Intervention / Treatment
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Besançon, France, 25030
- Centre hospitalier régional universitaire
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Estramustine
560 mg per day
|
Other Names:
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Active Comparator: Standard practice center
Standard treatment center choice. Excepted: anthracyclines, taxanes, capecitabine and eribulin |
standard practice
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Proportion of the alive patients without progress of the disease
Time Frame: 3 months
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
quality of life
Time Frame: 18 months
|
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 items (EORTC QLQ-C30)
|
18 months
|
|
progression-free survival
Time Frame: 18 months
|
18 months
|
|
|
overall survival
Time Frame: 18 months
|
18 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.