Efficacy and Safety of Estracyt® in Metastatic Breast Cancer

Breast Cancer Clinical Trial

— BEST  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02853071
• Other study ID #: P/2015/269
• Status: Withdrawn
• Phase: Phase 2
• Start date: January 2017
• Est. completion date: January 2020

Study information

• Verified date: November 2019
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Estramustine

• standard practice
standard practice

Locations

Country	Name	City	State
France	Centre Hospitalier Régional Universitaire	Besançon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of the alive patients without progress of the disease		3 months
Secondary	quality of life	European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 items (EORTC QLQ-C30)	18 months
Secondary	progression-free survival		18 months
Secondary	overall survival		18 months