The CORE Study (Chemotherapy or Endocrine Treatment first?) - CORE
- Conditions
- Patients with advanced breast cancer
- Registration Number
- EUCTR2005-000986-20-DE
- Lead Sponsor
- Technical University of Munich
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 1500
- histologically proven breast cancer
- Er+ or PgR+
- postmenopausal status
- female age <75
- ambulant patients (ECOG<2)
- metastatic or locally advanced breast cancer not having received systemic
treatment for recurrent or metastatic disease
- measurable or evaluable (See 7.1!) progressing metastases or local disease
- organ functions and performance status adequate for conventional combination
chemotherapy
- complete initial work-up within 4 weeks prior to first treatment.
- signed informed consent according to the local Ethics Committee requirements
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
- known HER2-positivity (3+ by immunohistochemistry or HER2 FISH/CISH +)
- concomitant treatment with radiotherapy, endocrine, cytotoxic or experimental
cancer therapy
- presence of cerebral or leptomeningeal metastases
- sclerotic bone-metastases only
- previous or concurrent malignancies at other sites, except basal cell carcinoma and
carcinoma cervicis uteri in situ (patients with bilateral breast cancer can be included)
- patients with immediately life-threatening metastatic disease (CT first is
recommended)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method