Clinical trial · Interventional
Epirubicin and Tamoxifen With or Without Docetaxel in Treating Postmenopausal Women With Breast Cancer
A Multicenter Randomized Trial of Sequential Epirubicin and Docetaxel Versus Epirubicin in Node Positive Postmenopausal Breast Cancer 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)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen by the tumor cells. Combining chemotherapy with hormone therapy may kill more tumor cells. PURPOSE: Randomized phase III trial to compare the effectiveness of epirubicin and tamoxifen with or without docetaxel in treating postmenopausal women who have breast cancer that has spread to the lymph nodes.
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| docetaxel | Drug | Docetaxel | ALIAS |
| epirubicin hydrochloride | Drug | Epirubicin | ALIAS |
| tamoxifen citrate | Drug | Tamoxifen | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Disease-free survival
- measure
- Overall survival
- measure
- Incidence of thromboembolic events during the first 9 months after randomization
Secondary outcomes (2)
- measure
- Tolerability
- measure
- Quality of life
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically proven node-positive breast cancer * Postmenopausal * Last menstrual period more than 12 months before initial surgery OR * Any age with prior bilateral oophorectomy OR * Age 50 or over with prior hysterectomy without oophorectomy (unrelated to malignancy) * No distant metastases * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * See Disease Characteristics Sex: * Female Menopausal status: * See Disease Characteristics Performance status: * WHO (ECOG) 0-1 Life expectancy: * Not specified Hematopoietic: * WBC at least 3,000/mm3 OR * Absolute neutrophil count at least 1,500/mm3 * Platelet count at least 100,000/mm3 Hepatic: * Bilirubin normal * SGOT and SGPT no greater than 1.5 times normal * Alkaline phosphatase no greater than 1.5 times normal Renal: * Creatinine less than 1.5 times normal Cardiovascular: * No history of significant angina, congestive heart failure, or myocardial infarction within the past year * No clinically significant arrhythmias or uncontrolled hypertension * LVEF normal by MUGA, LV gated scan, or echocardiogram Other: * No other concurrent serious illness * No other prior or concurrent malignancy except adequately treated squamous cell or basal cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Not specified Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * See Disease Characteristics
References
Publications (0)
Data not yet available