Breast Cancer
Conditions
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.
Interventions
DRUGEstramustine
standard practice
Sponsors
Centre Hospitalier Universitaire de Besancon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of the alive patients without progress of the disease | 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| quality of life | 18 months | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 items (EORTC QLQ-C30) |
| progression-free survival | 18 months | — |
| overall survival | 18 months | — |
Countries
France
Outcome results
None listed