A Randomized Phase III Study Comparing Pre- and Postoperative Vs. Conventional Adjuvant Treatment Hormone Receptor-Negative Breast Cancer Patients
Phase 3
18 Years
80 Years
18 Years
80 Years
Not Enrolling
Female
Early Stage Breast Cancer
Female
Early Stage Breast Cancer
Trial Information
A Randomized Phase III Study Comparing Pre- and Postoperative Vs. Conventional Adjuvant Treatment Hormone Receptor-Negative Breast Cancer Patients
Inclusion Criteria:
- Patients with bioptically verified breast cancer
- Estrogen receptor-negative status
- Age: < 70 years
- WHO Performance Status < 2
- Laboratory parameters
1. hematopoiesis: > 3500/l leukocytes, > 100,000/l thrombocytes
2. renal function: creatinin < 1.5mg%
3. hepatic function: GOT 2.5 x UNL
4. bilirubin: < 2.0 mg %
5. metabolic parameters: Na, Ca, K in normal range
-
- 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)
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall survival
Principal Investigator
Raimund Jakesz, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Austrian Breast & Colorectal Cancer Study Group
Authority:
Austria: Federal Ministry for Health and Women
Study ID:
ABCSG-7
NCT ID:
NCT00309569
Start Date:
October 1991
Completion Date:
Related Keywords:
- Early Stage Breast Cancer
- Cyclophosphamide
- Methotrexate
- Fluorouracil
- Epirubicine
- Breast Cancer
- Breast Neoplasms
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