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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
Information provided by:

March 31, 2006
April 3, 2006
May 19, 2006
December 1990
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  • Disease-free survival
  • Overall survival
Same as current
Complete list of historical versions of study NCT00309478 on ClinicalTrials.gov Archive Site
Same as current
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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.
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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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
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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)
Contact information is only displayed when the study is recruiting subjects
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Austrian Breast & Colorectal Cancer Study Group
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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