NCT00210028终止2 期
Open, Single-Arm Phase II Study Assessing Efficacy of ZARNESTRA™ Combined With Tamoxifen in Patients With Advanced or Metastatic Breast Cancer Expressing the Estrogen and/or Progesterone Receptor
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- To evaluate the objective response rate when ZARNESTRA is added to administration of tamoxifen in patients suffering from metastatic or advanced inoperable breast cancer, who are progressing on tamoxifen treatment
研究概览
简要总结
The purpose of this study is to evaluate the objective response rate when ZARNESTRA is added to treatment with tamoxifen
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Histologically proven, metastatic or locally advanced inoperable breast cancer
- •Tumor considered potentially hormone-sensitive, i.e. presence by IHC of hormone receptors for estrogens (ER+ for more than 10% of cells) and/or progesterone (Pg+ for more than 10% of cells) or both. This expression may have been detected on the primary tumor or at a metastatic site. The method used will be reassessed by IHC if it involves a radioligand technique whenever it is possible to obtain histological material.
- •Progressing on treatment with tamoxifen, given either as adjuvant treatment or for advanced/metastatic breast cancer. Any previous treatment with a steroidal or nonsteroidal antiaromatase in a neo-adjuvant, adjuvant or metastatic situation is permitted. Likewise, any previous treatment with chemotherapy and/or herceptin in a nonmetastatic situation is permitted.
- •Post-menopausal patients
- •Age > 18 years
- •At least one measurable lesion according to the Response Evaluation Criteria for Solid Tumors (RECIST) criteria; for patients who only have bone metastases, an evaluable non-irradiated lytic lesion is required
- •Performance Status (WHO): PS ≤ 2 (Appendix 1).
- •Laboratory tests in accordance with the following criteria:
- •Neutrophils ≥ 2x109/l,Platelets ≥ 100x109/l,Hemoglobin ≥ 10 g/dl, ASAT, ALAT ≤ 2.5 N , or < 5 N when liver metastasis,bilirubin ≤ 1.5 N creatinin ≤ 1.5 N
- •Signed, written consent before any study-related procedure
排除标准
- •Pre-menopausal patients who are not receiving concurrent LHRH agonist therapy
- •ER- and PR-negative patients
- •Contraindication to antiestrogens (thromboembolic risk) or ZARNESTRA
- •Non metastatic tumor susceptible to management by radiotherapeutic and/or surgical means
- •T4d inflammatory tumor (PEV 2 or 3).
- •Short-term, life-threatening lesions: hepatic invasion > 1/3 of liver volume, pulmonary lymphangitis, uncontrolled cerebral metastases, carcinomatous meningitis
- •Sensory neuropathy > or = grade 1 (WHO)
- •Previous history of uncontrolled cancers or controlled for less than 5 years, except basal cell skin cancers and in situ cancers of the cervix.
- •Chronic diseases (somatic or psychiatric) with a poor prognosis
- •subjects with enzyme-inducing anti-convulsants (e.g., phenytoin, phenobarbital, carbamazepine) : this treatment is not permitted while taking ZARNESTRA
- •Patients who, for family, social, geographic or psychological reasons, could not be followed up correctly.
结局指标
主要结局
To evaluate the objective response rate when ZARNESTRA is added to administration of tamoxifen in patients suffering from metastatic or advanced inoperable breast cancer, who are progressing on tamoxifen treatment
次要结局
- To evaluate the time to progression
- To evaluate the clinical benefit (response + stable disease at 6 months)
- To evaluate the safety of the combination ZARNESTRA and tamoxifen
- To evaluate a possible pharmacokinetic interaction between ZARNESTRA and tamoxifen
- To evaluate the biological predictive and prognostic factors of a response
研究者
研究点 (3)
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