Evaluation of the Efficacy of Estramustine in Patient With Breast Cancer Progression After Treatment With Aromatase Inhibitor.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 21
- 主要终点
- Progression-free survival after a 6- month monotherapy with Estramustine in patients with HER2-/RH+ breast cancer progressing
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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:
- •being treated with aromatase inhibitors (AIs)
- •after adjuvant treatment by AIs
- •after progression of the metastatic cancer in patients receiving AIs following positive response during at least 6 months
- •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
排除标准
- •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
- •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:
- •known presence of antiphospholipid antibody
- •family history of thrombophilia
- •existence of any clinical, genetic, or biological abnormality which can increase the risk of thromboembolic event according to the
- •Participation to a clinical trial at least 4 weeks prior the start of the study
研究组 & 干预措施
GROUP E (Estramustine)
Patients with HER2-/RH+ breast cancer progressing after having already undergone a first line adjuvant treatment by estramustine
干预措施: Estramustine (Drug)
GROUP T (Tamoxifen)
Patients with HER2-/RH+ breast cancer progressing after having already undergone a first line adjuvant treatment by tamoxifen
干预措施: Tamoxifen (Drug)
结局指标
主要结局
Progression-free survival after a 6- month monotherapy with Estramustine in patients with HER2-/RH+ breast cancer progressing
时间窗: up to 6 months
proportion of patients in progression-free survival (PFS) after a 6-month treatment 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
次要结局
- Risks of thrombosis(up to 6 months)
- Clinical benefit of estramustine(1 year)
- Correlation between the answer rate and biomarkers(1 year)
- Tolerance of estramustine treatment(1 year)
- Tolerance of tamoxifen treatments(1 year)
- Proportion of patients developing thromboembolic events(1 year)