EUCTR2005-005581-36-GB
Active, not recruiting
Phase 1
Randomized phase II study to investigate the efficacy, safety and tolerability of ZK 230211 (25 mg vs. 100 mg) as second-line endocrine therapy for postmenopausal women with hormone receptor-positive metastatic breast cancer
ConditionsMetastatic breast cancer
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Metastatic breast cancer
- Sponsor
- Bayer Schering Pharma AG
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients must meet all of the following inclusion criteria:
- •1\. Postmenopausal women defined as:
- •\- aged \>/\= 50 years with amenorrhea for at least 12 months or
- •\- aged stimulating
- •\- hormone (FSH) level within postmenopausal range (\> 40 mIU/ml) or
- •\- having undergone bilateral oophorectomy
- •2\. Histologically or cytologically confirmed breast cancer
- •3\. Metastatic breast cancer (Stage IV according to UICC – Union internationale
- •Contre Cancer \- criteria)
- •4\. Progesterone receptor (PR)\-positive tumors
Exclusion Criteria
- •Patients who meet any of the following criteria will be excluded:
- •1\. Presence of any of the following conditions:
- •\- life\-threatening metastatic visceral disease (extensive hepatic involvement)
- •\- any metastases to the central nervous system (CNS)
- •\- pulmonary lymphangitic metastases involving more than 50% of the lung
- •2\. More than one prior endocrine treatment for advanced breast cancer
- •3\. Malignancies or history of prior malignancy other than carcinoma in situ of the
- •cervix or uterus, or basal and squamous cell carcinoma of the skin
- •4\. Intake of CYP3A4 inhibitors less than 2 weeks before start of study treatment
- •5\. A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval \>450 milliseconds (ms))
Outcomes
Primary Outcomes
Not specified
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