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

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ClinicalTrials.gov Identifier: NCT00309478
Recruitment Status : Completed
First Posted : April 3, 2006
Last Update Posted : May 19, 2006
Sponsor:
Information provided by:
Austrian Breast & Colorectal Cancer Study Group

Brief Summary:
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 or disease Intervention/treatment Phase
Early-Stage Breast Cancer Drug: cyclophosphamide Drug: Methotrexate Drug: Fluorouracil Drug: Goserelin Drug: Tamoxifen Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 1099 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : December 1990

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Disease-free survival
  2. Overall survival

Secondary Outcome Measures :
  1. Toxicities


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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00309478


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

Additional Information:
ClinicalTrials.gov Identifier: NCT00309478     History of Changes
Other Study ID Numbers: ABCSG-5
First Posted: April 3, 2006    Key Record Dates
Last Update Posted: May 19, 2006
Last Verified: June 1999

Keywords provided by Austrian Breast & Colorectal Cancer Study Group:
Cyclophosphamide
Methotrexate
Fluorouracil
Goserelin
Tamoxifen
Breast cancer

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