Clinical trial · Interventional
A Trial Comparing Docetaxel Plus Fulvestrant With Docetaxel in Metastatic Breast Cancer
A Prospective Single-center Randomized Phase 2 Trial Comparing Docetaxel Plus Fulvestrant With Docetaxel in Postmenopausal, Hormone-receptor Positive and HER2-negative Metastatic Breast Cancer
NCT02137083CI-TRIAL-00031309completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
Comparing Docetaxel Plus Fulvestrant With Docetaxel in Patients With Metastatic 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 |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel | Drug | Docetaxel | ALIAS |
| Fulvestrant | Drug | Fulvestrant | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Docetaxel Plus Fulvestrant
- description
- Docetaxel:75mg/m2 D2 every 21 days Fulvestrant:500mg D1, D15, D29, D57, every 28 days later
- interventionNames
- Drug: Docetaxel
- Drug: Fulvestrant
- type
- ACTIVE_COMPARATOR
- label
- Docetaxel
- description
- Docetaxel:75mg/m2 D2 every 21 days
- interventionNames
- Drug: Docetaxel
Primary outcomes (1)
- measure
- Progression Free Survival
- timeFrame
- 6 weeks
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Postmenopausal female between 18 and 70 years old * ECOG performance status of ≤ 1 * Life expectancy more than 3 months * Histologically confirmed metastatic breast cancer * ER and\&or PR pqositive, HER2-negative * Disease progression during adjuvant or first-line endocrine therapy, or endocrine naive but unsuitable for endocrine therapy alone * No pretreated chemotherapy for metastatic disease * Have at least one target lesion according to RECIST 1.1 * No therapy (chemotherapy, endocrine therapy, target therapy and operation) within 4 weeks before enrollment * Hemoglobin ≥ 90 g/L, Absolute Neutrophil Count ≥ 1.5×10\^9/L, Platelet Count ≥ 75×10\^9/L, Serum Bilirubin ≤ 1.5×ULN, ALT and AST ≤ 1.5×ULN, Serum Creatinine ≤ 1×ULN, Endogenous Creatinine Clearance\>50ml/min Exclusion Criteria: * Pregnant or lactating women * Evidence of CNS metastasis * Seriously uncontrolled infection * History of another malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix * Pretreated with Fulvestrant * Pretreated with two or more lines of endocrine therapy
References
Publications (0)
Data not yet available
No reference posted for this study.