Clinical trial · Interventional
A Clinical Trial of Docetaxel and Oxaliplatin in Patients With Recurrent or Metastatic Breast Cancer
An Open-label, Multi-center Phase II Trial to Evaluate the Efficacy and Safety of Combination Chemotherapy With DoceTaxel(Detaxel) and Oxaliplatin(Oxalitin)in Recurrent or Metastatic Breast Cancer
NCT01351597CI-TRIAL-00004799STORMunknownPhase 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)
The purpose of this study is to evaluate the overall response rate, toxicity, progression free survival and quality of life of chemotherapy with docetaxel and oxaliplatin in recurrent or metastatic breast cancer.
Conditions
Conditions (2)
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 |
| Recurrent Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| docetaxel/ oxaliplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- docetaxel/ oxaliplatin
- description
- All the patients are recurrent or metastatic breast cancer. Patients with a measurable lesion.
- interventionNames
- Drug: docetaxel/ oxaliplatin
Primary outcomes (1)
- measure
- overall response rate
- timeFrame
- 2 years
Secondary outcomes (3)
- measure
- progression free survival
- timeFrame
- 2 years
- measure
- toxicity
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Women aged : 20\~70 years 2. WHO (ECOG) performance status 0-2 3. Patients with measurable lesion assessed by imaging using the RECIST (Response Evaluation Criteria In Solid Tumor) guideline 4. patients had previously not received chemotherapy of recurrent or metastatic lesion. 5. Have given written informed consent and are available for prolonged follow-up Exclusion Criteria: 1. Patients with previous chemotherapy for recurrent breast cancer 2. Breast cancer recurrence within 12 months after taxane treatment 3. Her-2/neu expression breast cancer 4. Patients with malignancies (other than breast cancer) within the last 5 years, except for adequately treated in situ carcinoma of the cervix or basal cell, squamous cell carcinoma of the skin. 5. Brain metastasis 6. uncontrolled infection, medically uncontrollable heart disease 7. other serious medical illness or prior malignancies 8. Pregnant or lactating women were excluded.
References
Publications (0)
Data not yet available
No reference posted for this study.