Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Early-stage Breast Cancer | Early Stage Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Fluorouracil implant | Drug | — | UNRESOLVED |
| Goserelin | Drug | Goserelin | ALIAS |
| Methotrexate | Drug | Methotrexate | ALIAS |
| Tamoxifen | Drug | Tamoxifen | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 2 (CMF scheme)
- description
- 6 cycles CMF scheme (cyclophosphamide, methotrexate, fluorouracil)
- interventionNames
- Drug: Cyclophosphamide
- Drug: Methotrexate
- Drug: Fluorouracil implant
- type
- EXPERIMENTAL
- label
- 1 (Nol + Zol)
- description
- Zoladex (3 years) combined with Nolvadex (5 years)
- interventionNames
- Drug: Goserelin
- Drug: Tamoxifen
Primary outcomes (2)
- measure
- Disease-free survival
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
Show eligibility criteria text
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)
References
Publications (0)
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