Description:
This study evaluates efficacy, safety and quality of life in patients affected by metastatic
breast cancer RH+/ HER2- and treated by estramustine phosphate.
Title
- Brief Title: Efficacy and Safety of Estracyt® in Metastatic Breast Cancer
- Official Title: Efficacy and Safety of Estracyt® in Metastatic Breast Cancer Hormonal Estrogen Receptor (HER 2) Negative, Hormone Receptor (HR) Positive.
Clinical Trial IDs
- ORG STUDY ID:
P/2015/269
- NCT ID:
NCT02853071
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Estramustine | estracyt, estramustine phosphate | Estramustine |
standard practice | | Standard practice center |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Estramustine | Experimental | 560 mg per day | |
Standard practice center | Active Comparator | Standard treatment center choice.
Excepted: anthracyclines, taxanes, capecitabine and eribulin | |
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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | Female |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Proportion of the alive patients without progress of the disease |
Time Frame: | 3 months |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | quality of life |
Time Frame: | 18 months |
Safety Issue: | |
Description: | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 items (EORTC QLQ-C30) |
Measure: | progression-free survival |
Time Frame: | 18 months |
Safety Issue: | |
Description: | |
Measure: | overall survival |
Time Frame: | 18 months |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Withdrawn |
Lead Sponsor: | Centre Hospitalier Universitaire de Besancon |
Last Updated
November 18, 2019