Neoadjuvant Chemotherapy With Docetaxel and Gemcitabine in Locally Advanced Breast Cancer
Conditions
Breast Cancer Stage II - Breast Cancer Stage III
Conditions: official terms
Breast Neoplasms
Conditions: Keywords
locally advanced breast cancer, docetaxel, gemcitabine
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: docetaxel Type: Drug
Name: gemcitabine Type: Drug
Overall Status
Not yet recruiting
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.
Detailed Description
Neoadjuvant chemotherapy is now standard for patients with locally advanced breast cancer, and this method of treatment has been extended to patients with earlier disease without affecting the treatment outcome. This single arm, multicenter phase II study was designed to evaluate the response rate, toxicity, progression free survival and tumor control rate of docetaxel and gemcitabine in the neoadjuvant setting with locally advanced 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. 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.
Location
Department of Surgery, the Catholic university of Korea, St. Vincent's hospital
Suwon, Gyeonggi-do, Korea, Republic of
Status: Recruiting
Contact: Young Jin Suh, M.D. Ph.D - 82-31-249-7114 - youngjin.suh@gmail.com
Start Date
May 2011
Completion Date
May 2015
Sponsors
Korean Breast Cancer Study Group
Source
Korean Breast Cancer Study Group
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page