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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


Phase 2
18 Years
N/A
Not Enrolling
Female
Metastatic Breast Cancer

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Trial Information

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


Inclusion Criteria:



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

- Histologically or cytologically confirmed breast cancer

- Metastatic breast cancer (Stage IV according to UICC - Union Internationale Contre
Cancer - criteria, Version 6)

- Progesterone receptor-positive tumors

- Patients must be considered candidates for endocrine therapy (no other therapies for
breast cancer are required)

- 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)

- At least one measurable or non-measurable tumor lesion (according to RECIST criteria)

- WHO Performance status 1

- 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: Endometrial thickness (in non-hysterectomized women) double layer

- No other uncontrolled concurrent illness

- Adequate recovery from previous surgery, radiation and chemotherapy

- Written informed consent

Exclusion Criteria:

- 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

- More than one prior endocrine treatment for advanced breast cancer

- Previous combination of endocrine treatment with any other type of treatment (except
chemotherapy), or previous sequential endocrine treatments (if there was disease
progression between treatments) are not permitted in this trial.

- Patients with breast cancer HER-2 positive or with unknown HER-2 status are not
eligible.

- 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

- Intake of CYP3A4 inhibitors less than 2 weeks before start of study treatment

- A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a
QTc interval >450 milliseconds (ms)

- A history of additional risk factors for TdP (e.g., heart failure, hypokalemia,
family history of Long QT Syndrome)

- The use of concomitant medications that prolong the QT/QTc interval

- Other investigational drug therapies less than 4 weeks or at least 5 half-lives
before start of study treatment (less than 4 weeks for faslodex and less than 2 weeks
for any other endocrine therapy)

- Expectation that the patient will not be able to complete at least 3 months of
therapy

- Unwillingness or inability to comply with the protocol

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

month 3, month 6

Safety Issue:

No

Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:

Bayer

Authority:

Austria: Federal Office for Safety in Health Care

Study ID:

91484

NCT ID:

NCT00555919

Start Date:

March 2008

Completion Date:

March 2011

Related Keywords:

  • Metastatic Breast Cancer
  • Metastatic breast cancer stage IV
  • Metastatic breast cancer
  • mBC
  • Stage IV breast cancer
  • Hormone receptor positive breast cancer
  • Breast Neoplasms

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