A Multi-center Phase II Trial to Evaluate the Efficacy and Safety of Neoadjuvant Chemotherapy With DoceTaxel(Doxotel) and Gemcitabine(Gemcibine)in Locally Advanced Breast Cancer
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Enrollment
- 99
- Locations
- 1
- Primary Endpoint
- Complete remission rate was assessed by pathologic examination after surgery.
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 70 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Women aged : 20~70 years
- •World Health Organization (WHO) (Eastern Cooperative Oncology Group [ECOG]) performance status 0-2
- •Patients with measurable lesion assessed by imaging using the RECIST (Response Evaluation Criteria In Solid Tumor) guideline
- •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.
Arms & Interventions
docetaxel/gemcitabine
All the patients are locally advanced breast cancer. Patients with a measurable lesion at chest CT. (at least 1 measurable lesion)
Intervention: docetaxel (Drug)
docetaxel/gemcitabine
All the patients are locally advanced breast cancer. Patients with a measurable lesion at chest CT. (at least 1 measurable lesion)
Intervention: gemcitabine (Drug)
Outcomes
Primary Outcomes
Complete remission rate was assessed by pathologic examination after surgery.
Time Frame: 2 years
Secondary Outcomes
- quality of life(2 years)
- Type of surgery (Breast Conserving Rate)(6 month)
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(1 year)
- progression free survival(2 years)