Overview

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

Status:
Unknown status
Trial end date:
2013-09-01
Target enrollment:
0
Participant gender:
Female
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Korean Breast Cancer Study Group
Treatments:
Docetaxel
Oxaliplatin
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.