- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00309478
Randomized Study Comparing CMF and Goserelin + Tamoxifen in Premenopausal Receptor-positive Patients
June 28, 2023 updated by: Austrian Breast & Colorectal Cancer Study Group
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1099
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 2 (CMF scheme)
6 cycles CMF scheme (cyclophosphamide, methotrexate, fluorouracil)
|
Cyclophosphamide 600mg/m2
Methotrexate 40mg/m2
Fluorouracil 600mg/m2
|
Experimental: 1 (Nol + Zol)
Zoladex (3 years) combined with Nolvadex (5 years)
|
Zoladex 3.6mg/28 days for 3 years
Other Names:
Nolvadex 20mg/day for 5 years
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Overall survival
|
Disease-free survival
|
Secondary Outcome Measures
Outcome Measure |
---|
Toxicities
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Raimund Jakesz, MD, Austrian Breast & Colorectal Cancer Study Group
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 1990
Primary Completion (Actual)
June 1, 2004
Study Completion (Actual)
June 1, 2004
Study Registration Dates
First Submitted
March 31, 2006
First Submitted That Met QC Criteria
March 31, 2006
First Posted (Estimated)
April 3, 2006
Study Record Updates
Last Update Posted (Actual)
June 29, 2023
Last Update Submitted That Met QC Criteria
June 28, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Dermatologic Agents
- Hormone Antagonists
- Bone Density Conservation Agents
- Estrogen Antagonists
- Reproductive Control Agents
- Selective Estrogen Receptor Modulators
- Estrogen Receptor Modulators
- Abortifacient Agents, Nonsteroidal
- Abortifacient Agents
- Folic Acid Antagonists
- Cyclophosphamide
- Fluorouracil
- Goserelin
- Methotrexate
- Tamoxifen
Other Study ID Numbers
- ABCSG-5
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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