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

Austrian Breast & Colorectal Cancer Study Group

Status and phase: Completed; Phase 3

Conditions: Early-stage Breast Cancer

Treatments: Drug: Goserelin; Drug: Cyclophosphamide; Drug: Tamoxifen; Drug: Fluorouracil implant; Drug: Methotrexate

Study type: Interventional

Funder types: NETWORK; Industry

Identifiers

NCT00309478

ABCSG-5

Details and patient eligibility

About

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.

Enrollment: 1,099 patients

Sex: Female

Ages: 19+ years old

Volunteers: No 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

  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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,099 participants in 2 patient groups

2 (CMF scheme)

Experimental group

Description:

6 cycles CMF scheme (cyclophosphamide, methotrexate, fluorouracil)

Treatment:

Drug: Fluorouracil implant

Drug: Methotrexate

Drug: Cyclophosphamide

1 (Nol + Zol)

Experimental group

Description:

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

Treatment:

Drug: Tamoxifen

Drug: Goserelin