Metastatic breast cancer
Conditions
Interventions
Product Name: ZK 230211
Product Code: SH T00208FA
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: n/a
CAS Number: n/a
Current Sponsor code: ZK 230211
Other descriptive name: ZK PRA
Concen
Sponsors
Schering AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 1. Postmenopausal women defined as: - aged >/= 50 years with amenorrhea for at least 12 months or - aged 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 5. Patients must be considered candidates for endocrine therapy (no other therapies for breast cancer are required) 6. Disease progression after first-line endocrine therapy for advanced breast cancer (i.e. with tumor remission or stabilization lasting at least 3 months under endocrine therapy) 7. At least one measurable or non measurable tumor lesion (according to RECIST criteria) 8. WHO Performance status 2 or lower 9. Adequate function of major organs and systems Hematopoietic: - Hemoglobin: >= 10 g/dL - Absolute neutrophil count: >= 1,500/mm3 - Platelet count: >= 100,000/mm3 Hepatic: - Total bilirubin: =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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. Other investigational drug therapies less than 4 weeks before start of study treatment 6. Expectation that the patient will not be able to complete at least 3 months of therapy 7. Unwillingness or inability to comply with the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate efficacy (clinical benefit), safety and tolerability, pharmacokinetics, and quality of life; additionally to develop biomarkers;Secondary Objective: n/a;Primary end point(s): Clinical Benefit (CB): proportion of patients with: - Complete response (CR) or partial response (PR) at any time point or - Stable disease (SD) for 6 months from the start of study treatment | — |
Countries
Austria, Finland, Germany, Italy, Spain, Sweden, United Kingdom
Outcome results
None listed