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

Phase 3

Completed

• Conditions: Early-stage Breast Cancer
• Interventions: Drug: Cyclophosphamide; Drug: Goserelin; Drug: Tamoxifen; Drug: Methotrexate; Drug: Fluorouracil implant

• Registration Number: NCT00309478
• Lead Sponsor: Austrian Breast & Colorectal Cancer Study Group

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1990-12
• Primary Completion: 2004-06
• Study Completion: 2004-06
• Study First Submitted: 2006-03-31
• Study First Submitted QC: 2006-03-31
• Study First Posted: 2006-04-03
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-28
• Last Update Posted: 2023-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1099

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/µl leukocytes, > 100,000/µl 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2 (CMF scheme)	Fluorouracil implant	6 cycles CMF scheme (cyclophosphamide, methotrexate, fluorouracil)
1 (Nol + Zol)	Tamoxifen	Zoladex (3 years) combined with Nolvadex (5 years)
2 (CMF scheme)	Cyclophosphamide	6 cycles CMF scheme (cyclophosphamide, methotrexate, fluorouracil)
2 (CMF scheme)	Methotrexate	6 cycles CMF scheme (cyclophosphamide, methotrexate, fluorouracil)
1 (Nol + Zol)	Goserelin	Zoladex (3 years) combined with Nolvadex (5 years)

Primary Outcome Measures

Name	Time	Method
Disease-free survival
Overall survival

Secondary Outcome Measures

Name	Time	Method
Toxicities