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

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized Phase III Study Comparing Cyclophosphamide + Methotrexate + Fluorouracil vs. Goserelin + Tamoxifen in Premenopausal, Hormone Receptor-positive, Lymph Node-positive or -Negative Patients

Conditions
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Early-stage Breast Cancer

Intervention / Treatment
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* Drug: Cyclophosphamide
* Drug: Methotrexate
* Drug: Fluorouracil implant
* Drug: Goserelin
* Drug: Tamoxifen


Participation Criteria
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Eligibility Criteria
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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 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)

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival |  |  | 
| Overall survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicities |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cyclophosphamide, Methotrexate, Fluorouracil, Goserelin, Tamoxifen, Breast cancer