Clinical trial · Interventional
Efficacy and Safety of Estracyt® in Metastatic Breast Cancer
Efficacy and Safety of Estracyt® in Metastatic Breast Cancer Hormonal Estrogen Receptor (HER 2) Negative, Hormone Receptor (HR) Positive.
NCT02853071CI-TRIAL-00041712BESTwithdrawnPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): withdrawal industrial
Summary
Brief summary (as posted)
This study evaluates efficacy, safety and quality of life in patients affected by metastatic breast cancer RH+/ HER2- and treated by estramustine phosphate.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Estramustine | Drug | Estramustine | ALIAS |
| standard practice | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Estramustine
- description
- 560 mg per day
- interventionNames
- Drug: Estramustine
- type
- ACTIVE_COMPARATOR
- label
- Standard practice center
- description
- Standard treatment center choice. Excepted: anthracyclines, taxanes, capecitabine and eribulin
- interventionNames
- Drug: standard practice
Primary outcomes (1)
- measure
- Proportion of the alive patients without progress of the disease
- timeFrame
- 3 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.