A Clinical Trial of Docetaxel and Oxaliplatin in Patients With Recurrent or Metastatic Breast Cancer
Recurrent Breast Cancer - Metastatic Breast Cancer
Conditions: official terms
Breast Neoplasms
Conditions: Keywords
recurrent breast cancer, metastatic breast cancer, docetaxel, oxaliplatin
Study Type
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Name: docetaxel/ oxaliplatin
Type: Drug
Overall Status
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
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 70 Years
Minimum Age: 20 Years
Gender: Female
Criteria: 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.
Department of Surgery, Breast Cancer Center, Inje University Paik Hospital
Seoul, Korea, Republic of
Status: Recruiting
Contact: Sehwan Han, MD. PhD. - 82-2-950-1018 - hanse@paik.ac.kr
Start Date
April 2011
Completion Date
September 2013
Korean Breast Cancer Study Group
Korean Breast Cancer Study Group
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page