Status:
COMPLETED
Randomized Study Comparing Pre- and Postoperative vs. Conventional Adjuvant Treatment in Receptor-negative Patients
Lead Sponsor:
Austrian Breast & Colorectal Cancer Study Group
Conditions:
Early Stage Breast Cancer
Eligibility:
FEMALE
18-80 years
Phase:
PHASE3
Brief Summary
Primarily, this clinical investigation compared overall survival and recurrence-free survival in patients with hormone receptor-negative breast cancer treated with pre- and postoperative chemotherapy ...
Eligibility Criteria
Inclusion
- Patients with bioptically verified breast cancer
- Estrogen receptor-negative status
- Age: \< 70 years
- WHO Performance Status \< 2
- Laboratory parameters
- hematopoiesis: \> 3500/mm3 leukocytes, \> 100,000/mm3 thrombocytes
- renal function: creatinin \< 1.5mg%
- hepatic function: GOT max. 2.5 x UNL
- bilirubin: \< 2.0 mg %
- metabolic parameters: Na, Ca, K in normal range
- \</= 4 weeks interval since surgery
- Informed consent
Exclusion
- Patients with locally inoperable cancer, M1
- Other preoperative tumor-specific radiotherapy, chemotherapy or endocrine treatment
- Pregnancy or lactation
- General contraindication against cytostatic treatment
- T4 cancer; inflammatory disease, simultaneous or sequential bilateral breast cancer
- Lacking compliance or understanding of disease
- Serious concomitant disease
- Second carcinoma or status post second carcinoma (except for treated squamous cell carcinoma of the skin or cervical carcinoma in situ)
Key Trial Info
Start Date :
October 1 1991
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2000
Estimated Enrollment :
429 Patients enrolled
Trial Details
Trial ID
NCT00309569
Start Date
October 1 1991
End Date
September 1 2000
Last Update
October 14 2020
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