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NCT Number: NCT00309478

Randomized Study Comparing CMF and Goserelin + Tamoxifen in Premenopausal Receptor-positive Patients

Primarily, this clinical investigation compared the efficacy of cyclophosphamide + methotrexate + fluorouracil chemotherapy vs. goserelin + tamoxifen treatment in terms of prognosis (disease-free survival, overall survival) in premenopausal patients with potentially curative, operated hormone receptor-positive breast cancer.

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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

19 year and older

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

  • Premenopausal patients with histologically verified, lymph node-negative (pT1c-pT3) or lymph node-positive (pT1a-pT3) breast cancer
  • Hormone receptor-positive status
  • More than 6 histologically examined lymph nodes
  • Laboratory parameters
  • hematopoiesis: > 3500/µl leukocytes, > 100,000/µl thrombocytes
  • renal function: creatinin < 1.5mg %
  • hepatic function: GOT </= 2.5 x UNL
  • bilirubin: < 1.5mg %
  • metabolic parameters: Na, Ca, K in normal range, normal level of blood sugar
  • blood coagulation: PZ > 60%
  • Concluded healing process following surgery
  • </= 4 weeks interval since surgery
  • Informed consent

Exclusion criteria

  • T4 carcinoma; inflammatory breast cancer, carcinoma in situ
  • Simultaneous or sequential bilateral breast cancer
  • Preoperative tumor-reducing radiotherapy or preoperative tumor-specific medical treatment
  • Male patients
  • Pregnancy or lactation
  • Lacking compliance or understanding of the disease
  • General contraindication against cytostatic treatment
  • Serious concomitant disease preventing implementation of adjuvant therapy or regular follow-up
  • Second carcinoma or status post second carcinoma (except for curatively 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 implant

Drug

Fluorouracil 600mg/m2

Goserelin

Drug

Zoladex 3.6mg/28 days for 3 years

Other names: Zoladex

Tamoxifen

Drug

Nolvadex 20mg/day for 5 years

Other names: Nolvadex

Primary outcomes

  1. Disease-free survival

  2. Overall survival

Secondary outcomes

  1. Toxicities

Sponsors and collaborators

Lead sponsor

Austrian Breast & Colorectal Cancer Study Group

Network

Collaborators

  • AstraZeneca

Registry information

Official study title

A Randomized Phase III Study Comparing Cyclophosphamide + Methotrexate + Fluorouracil vs. Goserelin + Tamoxifen in Premenopausal, Hormone Receptor-positive, Lymph Node-positive or -Negative Patients

Important dates

Study start
1990
Primary completion
2004
Study completion
2004
First posted
Apr 3, 2006
Registry last updated
Jun 29, 2023

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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