None listed
Conditions
Brief summary
Phase III trial to campare 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.
Interventions
The purpose of the study is to compare a high dose epirubicin/cyclophosphamide (EC) chemotherapy regimen, plus Filgrastim support, given over a 9 week period with a standard epirubicin/cyclophosphamide (EC) chemotherapy regimen given over 18 weeks. The total dose of EC is the same.
Sponsors
Australia and New Zealand Breast Cancer Trials Group Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No
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.
Outcome results
None listed