Etude de phase II randomisée multicentrique évaluant l'efficacité d’estramustine phosphate (Estracyt ®) chez des patientes présentant un cancer du sein métastatique HER2- / RH+ ayant déjà reçu un traitement par inhibiteur d’aromatase - EFESE

• Conditions: Metastases breast cancer in women already treated with aromatase inhibitors.; MedDRA version: 12.1Level: PTClassification code 10006187Term: Breast cancer

• Registration Number: EUCTR2009-017788-40-FR
• Lead Sponsor: CRLCC Alexis Vautrin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09-27
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

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

•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified