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OpenTrials
Completed

NCT Number: NCT00309569

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

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.

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Key information

Conditions

Early Stage Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Cyclophosphamide

Drug

Cyclophosphamide 600mg/m2

methotrexate

Drug

Methotrexate 40mg/m2

Fluorouracil

Drug

Fluorouracil 600mg/m2

Epirubicin

Drug

Epirubucin 60mg/m2 (only node-positive patients)

SURGERY

Other

Surgery

Primary outcomes

  1. Overall survival

  2. Recurrence-free survival

Secondary outcomes

  1. Rate of breast-conserving procedures

Sponsors and collaborators

Lead sponsor

Austrian Breast & Colorectal Cancer Study Group

Network

Registry information

Official study title

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

Important dates

Study start
1991
Primary completion
2000
Study completion
2000
First posted
Apr 3, 2006
Registry last updated
Oct 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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