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

This study has been completed.
Information provided by:
Austrian Breast & Colorectal Cancer Study Group
ClinicalTrials.gov Identifier:
First received: March 31, 2006
Last updated: May 18, 2006
Last verified: June 1999
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.

Condition Intervention Phase
Early-Stage Breast Cancer
Drug: cyclophosphamide
Drug: Methotrexate
Drug: Fluorouracil
Drug: Goserelin
Drug: Tamoxifen
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Phase III Study Comparing Cyclophosphamide + Methotrexate + Fluorouracil Vs. Goserelin + Tamoxifen in Premenopausal, Hormone Receptor-Positive, Lymph Node-Positive or -Negative Patients

Resource links provided by NLM:

Further study details as provided by Austrian Breast & Colorectal Cancer Study Group:

Primary Outcome Measures:
  • Disease-free survival
  • Overall survival

Secondary Outcome Measures:
  • Toxicities

Estimated Enrollment: 1099
Study Start Date: December 1990

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

    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: < 1.5mg %
    5. metabolic parameters: Na, Ca, K in normal range, normal level of blood sugar
    6. 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00309478

Sponsors and Collaborators
Austrian Breast & Colorectal Cancer Study Group
Principal Investigator: Raimund Jakesz, MD Austrian Breast & Colorectal Cancer Study Group
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00309478     History of Changes
Other Study ID Numbers: ABCSG-5 
Study First Received: March 31, 2006
Last Updated: May 18, 2006
Health Authority: Austria: Federal Ministry for Health and Women

Keywords provided by Austrian Breast & Colorectal Cancer Study Group:
Breast cancer

Additional relevant MeSH terms:
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Alkylating Agents
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Hormonal
Antirheumatic Agents
Bone Density Conservation Agents
Dermatologic Agents
Enzyme Inhibitors
Estrogen Antagonists
Estrogen Receptor Modulators
Folic Acid Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Nucleic Acid Synthesis Inhibitors
Physiological Effects of Drugs
Reproductive Control Agents
Selective Estrogen Receptor Modulators

ClinicalTrials.gov processed this record on May 26, 2016