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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00309478
First Posted: April 3, 2006
Last Update Posted: May 19, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Austrian Breast & Colorectal Cancer Study Group
March 31, 2006
April 3, 2006
May 19, 2006
December 1990
Not Provided
  • Disease-free survival
  • Overall survival
Same as current
Complete list of historical versions of study NCT00309478 on ClinicalTrials.gov Archive Site
Toxicities
Same as current
Not Provided
Not Provided
 
Randomized Study Comparing CMF and Goserelin + Tamoxifen in Premenopausal Receptor-Positive Patients
A Randomized Phase III Study Comparing Cyclophosphamide + Methotrexate + Fluorouracil Vs. Goserelin + Tamoxifen in Premenopausal, Hormone Receptor-Positive, Lymph Node-Positive or -Negative 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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Early-Stage Breast Cancer
  • Drug: cyclophosphamide
  • Drug: Methotrexate
  • Drug: Fluorouracil
  • Drug: Goserelin
  • Drug: Tamoxifen
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1099
Not Provided
Not Provided

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)
Sexes Eligible for Study: Female
19 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00309478
ABCSG-5
Not Provided
Not Provided
Not Provided
Not Provided
Austrian Breast & Colorectal Cancer Study Group
Not Provided
Principal Investigator: Raimund Jakesz, MD Austrian Breast & Colorectal Cancer Study Group
Austrian Breast & Colorectal Cancer Study Group
June 1999

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP