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Clinical Trials/NCT00309569
NCT00309569CompletedPhase 3

A Randomized Phase III Study Comparing Pre- and Postoperative vs. Conventional Adjuvant Treatment Hormone Receptor-negative Breast Cancer Patients

Austrian Breast & Colorectal Cancer Study Group0 sites429 target enrollmentStarted: October 1991Last updated:
Conditions
Interventions
Drugs

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)

Experimental

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)

Experimental

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)

Experimental

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)

Experimental

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)

Experimental

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)

Experimental

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)

Experimental

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)

Experimental

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)

Experimental

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)

Experimental

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

Investigators

Sponsor Class
Network
Responsible Party
Sponsor

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