A Clinical Trial of Docetaxel and Oxaliplatin in Patients With Recurrent or Metastatic Breast Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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Recent therapeutic developments, such as the introduction of new cytotoxic agents (taxanes, platinum, liposomal anthracyclines, etc) have resulted in constant improvements in treatment efficacy and consequently in recurrent or metastatic outcome. This single arm, multicenter phase II study was designed to evaluate the response rate, toxicity, progression free survival of docetaxel and oxaliplatin in patients with recurrence or metastatic breast cancer.

Official Title
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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

Conditions
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Recurrent Breast Cancer, Metastatic Breast Cancer

Intervention / Treatment
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* Drug: docetaxel/ oxaliplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women aged : 20 70 years WHO (ECOG) performance status 0-2 Patients with measurable lesion assessed by imaging using the RECIST (Response Evaluation Criteria In Solid Tumor) guideline patients had previously not received chemotherapy of recurrent or metastatic lesion. Have given written informed consent and are available for prolonged follow-up Exclusion Criteria: Patients with previous chemotherapy for recurrent breast cancer Breast cancer recurrence within 12 months after taxane treatment Her-2/neu expression breast cancer 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. Brain metastasis uncontrolled infection, medically uncontrollable heart disease other serious medical illness or prior malignancies Pregnant or lactating women were excluded.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: docetaxel/ oxaliplatin<br>All the patients are recurrent or metastatic breast cancer. Patients with a measurable lesion. | Drug: docetaxel/ oxaliplatin<br>* docetaxel - 75 mg/m2 with D5W250ml IV (in the vein)over 1 hr, every 3 weeks oxaliplatine - 70 mg/m2 with D5W250ml IV (in the vein)over 2 hrs, every 3 weeks<br>* Other names: oxalitin®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall response rate |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression free survival |  | 2 years | 
| toxicity |  | 2 years | 
| quality of life |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent breast cancer, metastatic breast cancer, docetaxel, oxaliplatin