An international randomized trial in Locally Advanced Breast Cancer comparing 6 courses of neo-adjuvant doxorubicin and cyclophosphamide plus GM-CSF or G-CSF with a split-course administration of 3 neo-adjuvant and 3 adjuvant cycles including either GM-CSF or G-CSF.
Suspended
- Conditions
- ocally advanced breast cancer.
- Registration Number
- NL-OMON27543
- Lead Sponsor
- VU medisch centrum
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Not specified
- Target Recruitment
- 720
Inclusion Criteria
1. Histologically proven breast cancer;
2. Locally advanced breast cancer: stage IIB with a primary breast tumor > 5 cm ©ª (T3 tumor), IIIA or IIIB according to the AJCC criteria;
Exclusion Criteria
1. Pregnant, or lactating patients. Patients of childbearing potential must use adequate contraception;
2. Distant metastases;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Recurrence of disease or all cause mortality (whichever comes first).
- Secondary Outcome Measures
Name Time Method 1. Disease-free survival;<br /><br>2. Overall survival;<br /><br>3. Response rate.