ANZ 9311. Phase III trial to compare the effect of a short high dose intensive course of chemotherapy with filgrastim support versus a conventional standard dose course of chemotherapy in patients with advanced breast cancer.
Phase 3
Completed
- Conditions
- Advanced Breast CancerCancer - Breast
- Registration Number
- ACTRN12605000478617
- Lead Sponsor
- Australia and New Zealand Breast Cancer Trials Group Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 225
Inclusion Criteria
Histologically proven primary breast cancer with recurrent and/or metastatic disease; no more than one previous cytotoxic chemotherapy regimen for recurrent or metastatic disease; disease must be measurable or evaluable; patient must be geographically accessible for follow up; written informed consent provided.
Exclusion Criteria
Past or recurrent malignancies at other sites, except adequately treated squamous or basal cell carcinoma of the skin, or carcinoma in situ of the cervix; radiotherapy in excess of regional therapy to primary disease, cranial therapy or limited localized therapy; patients whose only demonstrable disease is intracranial.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method