Metastases breast cancer in women already treated with aromatase inhibitors. MedDRA version: 12.1 Level: PT Classification code 10006187 Term: Breast cancer
Conditions
Interventions
Trade Name: ESTRACYT®
Pharmaceutical Form: Capsule*
Sponsors
CRLCC Alexis Vautrin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Post-menopausal women or women receiving LHRH analogs • Histologically confirmed metastatic breast cancer RH+ • Measurable metastatic breast cancer (modified RECIST criteria) or not mesurable but evaluable • Recurrence: - being treated with aromatase inhibitors (AIs) - less than one year after adjuvant treatment by AIs - after progression of the metastatic cancer in patients receiving AIs following positive response during at least 6 months • Performance index = 2 (OMS) • Haematological test: polynuclear neutrophiles = 1.5 × 109 /L, haemoglobin = 9 g/dL, blood platelet = 100 × 109 /L • Hepatic function: albumin = 2.5 g/dL, serum bilirubin = 1.5 × N (except if Gilbert’s Syndrome) , aminotransferases = 3 × N (= 5 × N if hepatic metastases) • Renal function: serum creatinine = 1.5 mg/dL or clearance of creatinine = 40 ml/min • Women without endometrial pathology • Patient who agrees, according to the investigator, to comply with the study requirements • Signed informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Women aged < 18 • Pre-menopausal, pregnant or lactating females • Patient who should exclusively be treated by chemotherapy • Women previously treated with chemotherapy but not by AIs • Women previously treated by tamoxifene for their metastatic breast cancer • HER2+ tumour • Concurrent anti-cancer treatment (chemotherapy, surgery, immunotherapy, biological therapy and tumour embolism) • Concurrent treatment with protocol-defined prohibited medications • Malabsorption syndrome , significant digestive dysfunction, gastrectomy, jejunectomy, hemorrhagic recto colon • Concurrent disease or condition that may interfere with study participation, or any serious medical disorder that would interfere with the subject's safety (for example, active or uncontrolled infection or any psychiatric condition prohibiting understanding or rendering of informed consent) • Any pathology, including severe psychiatric or psychologic disease that may harm patient’s safety or participation in the study • Serious or not cured or unstable toxicity due to the administration of another drug being involved in clinical trials • Uncontrolled cardiovascular pathologies • Previous cardiovascular disease of type deep vein thrombosis or pulmonary embolism recorded within one year before the inclusion date • Active uncontrolled infection • Risk of thromboembolic events such as: - personal history of any thromboembolic event - antiphospholipid antibody - family history of thrombophilia • Participation to a clinical trial at least 4 weeks prior the start of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the percentage of progression free survival after a 6-month monotherapy of Estramustine in patients with HER2-/RH+ breast cancer progressing after having already undergone either a first line adjuvant treatment by aromatase inhibitors (AI);Secondary Objective: - To describe the risks of thrombosis by the analysis of the following biomarkers : D-Dimer, prothrombin fragment 1+2, von Willebrand factor, fibrinogen, Chain Reaction Protein (CRP) - To describe the clinical benefit of estramustine every 2 months during the one-year patient follow-up (RECIST criteria) - To describe the correlation between the answer rate and the decrease of the following biomarkers: LDH, ACE and CA 15-3 every 2 months during the one-year patient follow-up - To evaluate tolerance of estramustine and tamoxifene treatments every 2 months during the one-year patient follow-up - To analyse the proportion of patients developing thromboembolic events in the 2 groups every month every during the one-year patient follow-up - To evaluate patient's quality of life (questionnaire EORTC QLQ-C30 and EORTC QLQ-BR23) every 4 months every during the one-year patient follow-up ;Primary end point(s): Proportion of patients in progression-free survival (PFS) after a 6-month treatment is the main judgement criterion. The PFS is defined as the duration of objective response or stabilisation of the disease according to the Recist criteria. The following events shall be considered as progressive : - Relapse - Treatment intolerance leading to stop the treatment - Death | — |
Countries
France
Outcome results
None listed