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

• Register: EUCTR
• Last refreshed on: 7 January 2013
• Main ID: EUCTR2005-005581-36-IT
• Date of registration: 13/07/2007
• Prospective Registration: Yes
• Primary sponsor: SCHERING
• Public title: 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
• Scientific title: 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
• Date of first enrolment: 24/12/2007
• Target sample size: 72
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-005581-36
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: Placebo: Other: Other specify the comparator: - same IMP used at different dosage Number of treatment arms in the trial: 2

Countries of recruitment

Austria, Finland, Germany, Italy, Spain, Sweden, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
1. Postmenopausal women defined as: - aged >= 50 years with amenorrhea for at least 12 months or - aged minor/equal 50 years with 6 months of spontaneous amenorrhea and follicle 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, Version 6) 4. Progesterone receptor-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 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: <= 1.5 times the upper limit of normal - AST/ALT: <= 2.5 times the upper limit of normal ? Renal: - Creatinine: <= 1.5 times the upper limit of normal ? Gynecological: - Normal endometrial thickness (in non-hysterectomized women) No other uncontrolled concurrent illness 10. Adequate recovery from previous surgery, radiation and chemotherapy 11. Written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range: 0
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

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 (see Attachment 3) less than 2 weeks before start of study treatment 5. Other investigational drug therapies less than 4 weeks or at least 5 half lives 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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: no

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Cancer [C04]

metastatic breast cancer
MedDRA version: 14.1 Level: PT Classification code 10055113 Term: Breast cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Intervention(s)

Product Name: ZK 230211
Product Code: SHT00208FA
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: HORMONE ANTAGONISTS AND RELATED AGENTS
Current Sponsor code: ZK 230211
Concentration unit: mg milligram(s)
Concentration number: 25-

Product Name: ZK 230211
Product Code: SH T00208GA
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: HORMONE ANTAGONISTS AND RELATED AGENTS
Current Sponsor code: ZK 230211
Concentration unit: mg milligram(s)
Concentration number: 50-

Primary Outcome(s)

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

Main Objective: To evaluate efficacy (clinical benefit) of two doses of ZK PRA (25 mg and 100 mg) when administered once daily p.o.

Secondary Objective: To evaluate: safety and tolerability; pharmacokinetics of ZK PRA; the effect of ZK PRA on quality of life (QoL); to perform exploratory analysis of biomarkers.

Secondary ID(s)

2005-005581-36/309821

2005-005581-36-AT