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

Early-stage Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00309478
• Other study ID #: ABCSG-5
• Status: Completed
• Phase: Phase 3
• Start date: December 1990
• Est. completion date: June 2004

Study information

• Verified date: June 2023
• Source: Austrian Breast & Colorectal Cancer Study Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1099
• Est. completion date: June 2004
• Est. primary completion date: June 2004
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Breast Neoplasms
• Early-stage Breast Cancer

Intervention

Drug:
• Cyclophosphamide
Cyclophosphamide 600mg/m2
• Methotrexate
Methotrexate 40mg/m2
• Fluorouracil implant
Fluorouracil 600mg/m2
• Goserelin
Zoladex 3.6mg/28 days for 3 years
• Tamoxifen
Nolvadex 20mg/day for 5 years

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Austrian Breast & Colorectal Cancer Study Group	AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival
Primary	Overall survival
Secondary	Toxicities

External Links

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