Randomized Study Comparing Pre- and Postoperative vs. Conventional Adjuvant Treatment in Receptor-negative Patients

• Status: Completed
• Trial end date: 2000-09-01
• Target enrollment: 0
• Participant gender: Female

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 vs. conventional postoperative treatment.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Austrian Breast & Colorectal Cancer Study Group
• Treatments: Cyclophosphamide; Epirubicin; Fluorouracil; Methotrexate

Criteria

Inclusion Criteria:

• Patients with bioptically verified breast cancer

• Estrogen receptor-negative status

• Age: < 70 years

• WHO Performance Status < 2

• Laboratory parameters

1. hematopoiesis: > 3500/mm3 leukocytes, > 100,000/mm3 thrombocytes

2. renal function: creatinin < 1.5mg%

3. hepatic function: GOT max. 2.5 x UNL

4. bilirubin: < 2.0 mg %

5. metabolic parameters: Na, Ca, K in normal range

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• Informed consent

Exclusion Criteria:

• 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)