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

Sponsor

Austrian Breast & Colorectal Cancer Study Group (Other)

Overall Status

Completed

CT.gov ID

NCT00309478

Collaborator

AstraZeneca (Industry)

1,099

Enrollment

Arms

162

Actual Duration (Months)

Study Details

Study Description

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 implant Drug: Goserelin Drug: Tamoxifen	Phase 3

Study Design

Study Type:

Interventional

Actual 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

Actual Study Start Date :

Dec 1, 1990

Actual Primary Completion Date :

Jun 1, 2004

Actual Study Completion Date :

Jun 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 2 (CMF scheme) 6 cycles CMF scheme (cyclophosphamide, methotrexate, fluorouracil)	Drug: Cyclophosphamide Cyclophosphamide 600mg/m2 Drug: Methotrexate Methotrexate 40mg/m2 Drug: Fluorouracil implant Fluorouracil 600mg/m2
Experimental: 1 (Nol + Zol) Zoladex (3 years) combined with Nolvadex (5 years)	Drug: Goserelin Zoladex 3.6mg/28 days for 3 years Other Names: Zoladex Drug: Tamoxifen Nolvadex 20mg/day for 5 years Other Names: Nolvadex

Arm

Intervention/Treatment

Experimental: 2 (CMF scheme)

6 cycles CMF scheme (cyclophosphamide, methotrexate, fluorouracil)

Drug: Cyclophosphamide

Cyclophosphamide 600mg/m2

Drug: Methotrexate

Methotrexate 40mg/m2

Drug: Fluorouracil implant

Fluorouracil 600mg/m2

Experimental: 1 (Nol + Zol)

Zoladex (3 years) combined with Nolvadex (5 years)

Drug: Goserelin

Zoladex 3.6mg/28 days for 3 years

Other Names:

Zoladex

Drug: Tamoxifen

Nolvadex 20mg/day for 5 years

Other Names:

Nolvadex

Outcome Measures

Primary Outcome Measures

Disease-free survival []
Overall survival []

Secondary Outcome Measures

Toxicities []

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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)