Trials / Completed
CompletedNCT00309478
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
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,099 (actual)
- Sponsor
- Austrian Breast & Colorectal Cancer Study Group · Network
- Sex
- Female
- Age
- 19 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Cyclophosphamide | Cyclophosphamide 600mg/m2 |
| DRUG | Methotrexate | Methotrexate 40mg/m2 |
| DRUG | Fluorouracil implant | Fluorouracil 600mg/m2 |
| DRUG | Goserelin | Zoladex 3.6mg/28 days for 3 years |
| DRUG | Tamoxifen | Nolvadex 20mg/day for 5 years |
Timeline
- Start date
- 1990-12-01
- Primary completion
- 2004-06-01
- Completion
- 2004-06-01
- First posted
- 2006-04-03
- Last updated
- 2023-06-29
Source: ClinicalTrials.gov record NCT00309478. Inclusion in this directory is not an endorsement.