A Randomized Phase III Study Comparing Pre- and Postoperative vs. Conventional Adjuvant Treatment Hormone Receptor-negative Breast Cancer Patients
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 429
- Primary Endpoint
- Overall survival
Study Overview
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 vs. conventional postoperative treatment.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 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)
Arms & Interventions
A (pre- + postoperative chemotherapy)
3 cycles CMF (cyclophophamide + Methotrexat + 5-Fluorouracil) followed by surgery. Subsequently node-positive patients received 3 cycles anthracycline-based chemotherapy regime EC (epirubicin + cyclophosphamide) and node-negative patients another 3 cycles CMF.
Intervention: Cyclophosphamide (Drug)
A (pre- + postoperative chemotherapy)
3 cycles CMF (cyclophophamide + Methotrexat + 5-Fluorouracil) followed by surgery. Subsequently node-positive patients received 3 cycles anthracycline-based chemotherapy regime EC (epirubicin + cyclophosphamide) and node-negative patients another 3 cycles CMF.
Intervention: Methotrexate (Drug)
A (pre- + postoperative chemotherapy)
3 cycles CMF (cyclophophamide + Methotrexat + 5-Fluorouracil) followed by surgery. Subsequently node-positive patients received 3 cycles anthracycline-based chemotherapy regime EC (epirubicin + cyclophosphamide) and node-negative patients another 3 cycles CMF.
Intervention: Fluorouracil (Drug)
A (pre- + postoperative chemotherapy)
3 cycles CMF (cyclophophamide + Methotrexat + 5-Fluorouracil) followed by surgery. Subsequently node-positive patients received 3 cycles anthracycline-based chemotherapy regime EC (epirubicin + cyclophosphamide) and node-negative patients another 3 cycles CMF.
Intervention: Epirubicin (Drug)
A (pre- + postoperative chemotherapy)
3 cycles CMF (cyclophophamide + Methotrexat + 5-Fluorouracil) followed by surgery. Subsequently node-positive patients received 3 cycles anthracycline-based chemotherapy regime EC (epirubicin + cyclophosphamide) and node-negative patients another 3 cycles CMF.
Intervention: Surgery (Other)
B (conventional postoperative chemotherapy)
Surgery followed by 3 cycles CMF (cyclophophamide + Methotrexat + 5-Fluorouracil). Subsequently node-positive patients received 3 cycles anthracycline-based chemotherapy regime EC (epirubicin + cyclophosphamide) and node-negative patients another 3 cycles CMF.
Intervention: Cyclophosphamide (Drug)
B (conventional postoperative chemotherapy)
Surgery followed by 3 cycles CMF (cyclophophamide + Methotrexat + 5-Fluorouracil). Subsequently node-positive patients received 3 cycles anthracycline-based chemotherapy regime EC (epirubicin + cyclophosphamide) and node-negative patients another 3 cycles CMF.
Intervention: Methotrexate (Drug)
B (conventional postoperative chemotherapy)
Surgery followed by 3 cycles CMF (cyclophophamide + Methotrexat + 5-Fluorouracil). Subsequently node-positive patients received 3 cycles anthracycline-based chemotherapy regime EC (epirubicin + cyclophosphamide) and node-negative patients another 3 cycles CMF.
Intervention: Fluorouracil (Drug)
B (conventional postoperative chemotherapy)
Surgery followed by 3 cycles CMF (cyclophophamide + Methotrexat + 5-Fluorouracil). Subsequently node-positive patients received 3 cycles anthracycline-based chemotherapy regime EC (epirubicin + cyclophosphamide) and node-negative patients another 3 cycles CMF.
Intervention: Epirubicin (Drug)
B (conventional postoperative chemotherapy)
Surgery followed by 3 cycles CMF (cyclophophamide + Methotrexat + 5-Fluorouracil). Subsequently node-positive patients received 3 cycles anthracycline-based chemotherapy regime EC (epirubicin + cyclophosphamide) and node-negative patients another 3 cycles CMF.
Intervention: Surgery (Other)
Outcomes
Primary Outcomes
Overall survival
Recurrence-free survival
Secondary Outcomes
- Rate of breast-conserving procedures