EUCTR2006-002814-37-FR进行中（未招募）1 期
A phase II study of BIBW 2992 added to letrozole in patients with estrogen receptor positive hormone refractory metastatic breast cancer progressing on letrozole -
Boehringer Ingelheim France S.A.S.0 个研究点目标入组 40 人开始时间: 2006年8月25日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1. Female patients with histologically proven breast adenocarcinoma,
- •2. Age = 18 years,
- •3. Presence of metastatic disease,
- •4. Chemo-naïve patients (no prior chemotherapy for metastatic disease; patients who have received adjuvant chemotherapy including trastuzumab for early breast cancer in the past are eligible),
- •5. Patients with estrogen receptor positivity (IHC = 10%) on the most recently examined tumor biopsy,
- •6. Patients must currently be on letrozole and developed acquired resistance as defined by disease progression on letrozole following previous response (partial response or better, or stable disease = 24 weeks),
- •7. Diagnosis of disease progression = 6 weeks prior to trial entry defined as:
- •a. Increase in the number of bone lesions on bone scan or on MRI, AND/OR
- •b. Increased pain in an area of known bony metastasis AND = 2 serial elevations in CA 15-3, AND/OR
- •c. Progression according to RECIST criteria on CT scan, MRI, or x-ray,
- •8. Patients must have documented menopause confirmed by estradiol level < 11 pg/ml (patients having medical ovarian suppression by LHRH analogues will be excluded),
- •9. Estimated life expectancy = 6 months,
- •10. ECOG performance status 0 or 1,
- •11. Patient must be able to comply with the protocol,
- •12. Patients should not have received treatment with chemotherapy, radiotherapy, or immune therapy within the last 4 weeks prior to study enrolment,
- •13. Patients must have recovered from any grade 3 (according to US CTCAE version 3.0) adverse events from previous treatment,
- •14. Patient must have signed and dated written informed consent form.
- •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
排除标准
- •1. Active or uncontrolled infectious disease,
- •2. Gastrointestinal disorders that may interfere with the absorption of the study drugs or chronic diarrhea or difficulty to swallow,
- •3. Premenopausal patients,
- •4. Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the protocol,
- •5. History of other malignancies in the last 5 years, which could affect compliance with the protocol or interpretation of results. Patients with adequately treated basal or squamous cell carcinoma of skin and cervical carcinoma in situ are generally eligible,
- •6. Rapidly progressive disease in major organs (i.e., lymphangitic spread in the lung and/or bulky liver metastasis),
- •7. Patient with brain metastasis,
- •8. Significant cardiovascular diseases (i.e. uncontrolled hypertension, unstable angina, history of infarction, congestive heart failure > NYHA II) within the past 12 months,
- •9. Cardiac left ventricular function with resting ejection fraction inferior to the normal value,
- •10. Absolute neutrophil count (ANC) < 1500/mm3,
- •11. Platelet count < 100 000/mm3,
- •12. AST and/or ALT > 3x ULN (In case of known liver metastases AST and/or ALT > 5 x ULN),
- •13. Serum creatinine > 1.5 mg/dL (>132 µmol/L, SI unit or equivalent),
- •14. Concomitant treatment with any other investigational device or drugs, chemotherapy, immunotherapy, radiotherapy, or participation in another clinical study within the past four weeks before start of therapy or concomitantly during the study. Treatment with bisphosphonates are allowed during the study, as long as patient has been on a stable dose for at least 3 months prior to study entry),
- •15. Previous treatment with an EGFR and/or HER-2 inhibiting drug (Patients who received trastuzumab only in the adjuvant setting can be enrolled),
- •16. Active alcohol or drug abuse.
研究者
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