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
1 other identifier
interventional
1,099
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 1990
Longer than P75 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 1990
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2004
CompletedFirst Submitted
Initial submission to the registry
March 31, 2006
CompletedFirst Posted
Study publicly available on registry
April 3, 2006
CompletedJune 29, 2023
June 1, 2023
13.5 years
March 31, 2006
June 28, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Disease-free survival
Overall survival
Secondary Outcomes (1)
Toxicities
Study Arms (2)
2 (CMF scheme)
EXPERIMENTAL6 cycles CMF scheme (cyclophosphamide, methotrexate, fluorouracil)
1 (Nol + Zol)
EXPERIMENTALZoladex (3 years) combined with Nolvadex (5 years)
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Austrian Breast & Colorectal Cancer Study Grouplead
- AstraZenecacollaborator
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Raimund Jakesz, MD
Austrian Breast & Colorectal Cancer Study Group
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 31, 2006
First Posted
April 3, 2006
Study Start
December 1, 1990
Primary Completion
June 1, 2004
Study Completion
June 1, 2004
Last Updated
June 29, 2023
Record last verified: 2023-06