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

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 72

Inclusion Criteria

1. 1.Postmenopausal women defined as:
- aged >/= 50 years with amenorrhea for at least 12 months or
- aged - 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
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:<=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:
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 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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:<br>- Complete response (CR) or partial response (PR) at any time point<br>or<br>- Stable disease (SD) for 6 months from the start of study treatment<br>

Secondary Outcome Measures

Name	Time	Method

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