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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00309478

Enrollment

1099

Registered

2006-04-03

Start date

1990-12-31

Completion date

2004-06-30

Last updated

2023-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early-stage Breast Cancer

Keywords

Cyclophosphamide, Methotrexate, Fluorouracil, Goserelin, Tamoxifen, Breast cancer

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.

Interventions

DRUGCyclophosphamide

Cyclophosphamide 600mg/m2

DRUGMethotrexate

Methotrexate 40mg/m2

DRUGFluorouracil implant

Fluorouracil 600mg/m2

DRUGGoserelin

Zoladex 3.6mg/28 days for 3 years

DRUGTamoxifen

Nolvadex 20mg/day for 5 years

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

19 Years to No maximum

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)

Design outcomes

Primary

Measure	Time frame
Disease-free survival	—
Overall survival	—

Secondary

Measure	Time frame
Toxicities	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026