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Despite advances in early detection and treatment strategy, about 25 to 40% of patients treated for breast cancer develop metastasis.
Some patients are in a therapeutic impasse situation. It is therefore necessary to consider all possible options. The Estramustine showed encouraging results in the treatment of metastatic breast cancer.
Given the clinical data, the answer rate of Estramustine and its impact on progression free survival deserve to be studied in earlier clinical situation.
This Phase II study evaluated the efficacy of Estramustine in women with breast cancer and metastates, already treated with aromatase inhibitors and for whom this treatment has failed.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Post-menopausal women or women receiving Luteinizing hormone-releasing hormone (LHRH) analogs
Histologically confirmed metastatic breast cancer RH+
Measurable metastatic breast cancer (modified RECIST criteria) or not measurable but evaluable
Recurrence:
Performance status ≤ 2
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
Ability to provide written informed consent before the start of any study specific procedures
Exclusion criteria
Age < 18 years old
Pre-menopausal, pregnant or pregnant or breast feeding females
Patient who should exclusively be treated by chemotherapy
Women previously treated with chemotherapy but not by AIs
Women previously treated by tamoxifen for their metastatic breast cancer
HER2+
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 history of thromboembolic event like deep vein thrombosis or pulmonary embolism recorded within one year before the inclusion date
Active uncontrolled infection
Existence of an increased risk of thromboembolic event, apart from the metastatic cancer condition, such as:
Participation to a clinical trial at least 4 weeks prior the start of the study
Primary purpose
Allocation
Interventional model
Masking
100 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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