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

Primary Purpose

Breast Cancer

Status
Withdrawn
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Estramustine
standard practice
Sponsored by
Centre Hospitalier Universitaire de Besancon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hospitalier Régional Universitaire

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Estramustine

Standard practice center

Arm Description

560 mg per day

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

Outcomes

Primary Outcome Measures

Proportion of the alive patients without progress of the disease

Secondary Outcome Measures

quality of life
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 items (EORTC QLQ-C30)
progression-free survival
overall survival

Full Information

First Posted
July 29, 2016
Last Updated
November 15, 2019
Sponsor
Centre Hospitalier Universitaire de Besancon
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1. Study Identification

Unique Protocol Identification Number
NCT02853071
Brief Title
Efficacy and Safety of Estracyt® in Metastatic Breast Cancer
Acronym
BEST
Official Title
Efficacy and Safety of Estracyt® in Metastatic Breast Cancer Hormonal Estrogen Receptor (HER 2) Negative, Hormone Receptor (HR) Positive.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Withdrawn
Why Stopped
withdrawal industrial
Study Start Date
January 2017 (undefined)
Primary Completion Date
January 2020 (Anticipated)
Study Completion Date
January 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Estramustine
Arm Type
Experimental
Arm Description
560 mg per day
Arm Title
Standard practice center
Arm Type
Active Comparator
Arm Description
Standard treatment center choice. Excepted: anthracyclines, taxanes, capecitabine and eribulin
Intervention Type
Drug
Intervention Name(s)
Estramustine
Other Intervention Name(s)
estracyt, estramustine phosphate
Intervention Type
Drug
Intervention Name(s)
standard practice
Intervention Description
standard practice
Primary Outcome Measure Information:
Title
Proportion of the alive patients without progress of the disease
Time Frame
3 months
Secondary Outcome Measure Information:
Title
quality of life
Description
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 items (EORTC QLQ-C30)
Time Frame
18 months
Title
progression-free survival
Time Frame
18 months
Title
overall survival
Time Frame
18 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Centre Hospitalier Régional Universitaire
City
Besançon
ZIP/Postal Code
25030
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The Committee shall meet twice a year

Learn more about this trial

Efficacy and Safety of Estracyt® in Metastatic Breast Cancer

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