Status:
TERMINATED
Adjuvant Breast Cancer Study of the Netherlands Working Party for Autotransplantation in Solid Tumors
Lead Sponsor:
University Medical Center Groningen
Conditions:
High-Risk Breast Cancer
Eligibility:
FEMALE
18-50 years
Phase:
PHASE2
Brief Summary
Objectives of the study: This randomized multicenter phase II study compares the tolerability, toxicity and quality of life between two high-dose chemotherapy regimens based on cyclophosphamide, thio...
Detailed Description
High-dose chemotherapy with the alkylating agent combination CTC appears to add significantly to the efficacy of conventional dose chemotherapy in patients with high-risk breast cancer, provided that ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Modified radical mastectomy (or breast conserving surgery) and axillary clearance, histologically confirmed stage IIA, IIB or IIIA adenocarcinoma (excluding supraclavicular lymph nodes) of the breast, with 4 or more involved axillary lymph nodes. Presence of tumor cells near or in the resection margins at microscopic examination is acceptable
- The primary tumor must be immunohistochemically negative for HER-2/neu expression. An immunohistochemistry score of 1+ is also acceptable. A score of 3+ is not acceptable. A score of 2+ is only acceptable if a FISH analysis (or equivalent) has clearly shown that there is no HER-2/neu gene-amplification
- No prior chemotherapy or radiotherapy
- No evidence of distant metastases
- Age \< 50 years
- Performance status (ECOG-ZUBROD) 0 or 1;
- Normal bone marrow function, WBC \> 4.0 x 109/l, platelets \> 100 x 109/l;
- Adequate renal function (creatinine clearance \> 60 ml/min.);
- Adequate hepatic function (serum bilirubin \< 25 umol/l);
- Study treatment must begin within 6 weeks of surgery;
- No other malignancy except adequately treated in situ carcinoma of the cervix or basal cell carcinoma of the skin;
- No significant prior or concomitant disorder that might interfere with adherence to the intensive treatment regimen, including but not limited to a history of angina, myocardial infarction or heart failure, severe lung function impairment, peptic ulcer disease, etc.;
- Availability for follow-up.
Exclusion
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00851110
Start Date
October 1 2004
Last Update
February 25 2009
Active Locations (10)
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1
Free University Hospital
Amsterdam, Netherlands, 1007 MB
2
The Netherlands Cancer Institute
Amsterdam, Netherlands, 1066 CX
3
Academic Medical Center
Amsterdam, Netherlands, 1105 AZ
4
Medisch Spectrum Twente
Enschede, Netherlands, 7511 JX