Overview

Neoadjuvant Chemotherapy With Docetaxel and Gemcitabine in Locally Advanced Breast Cancer

Status:
Unknown status
Trial end date:
2015-05-01
Target enrollment:
0
Participant gender:
Female
Summary
The purpose of this study is to assess the response of docetaxel and gemcitabine in the neoadjuvant setting in women with locally advanced breast cancer.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Korean Breast Cancer Study Group
Treatments:
Docetaxel
Gemcitabine
Criteria
Inclusion Criteria:

1. Women aged : 20~70 years

2. World Health Organization (WHO) (Eastern Cooperative Oncology Group [ECOG])
performance status 0-2

3. Patients with measurable lesion assessed by imaging using the RECIST (Response
Evaluation Criteria In Solid Tumor) guideline

4. 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.