Neoadjuvant Chemotherapy With Docetaxel and Gemcitabine in Locally Advanced Breast Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Breast Cancer Stage II, Breast Cancer Stage III

Intervention / Treatment
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* Drug: docetaxel
* Drug: gemcitabine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: docetaxel/gemcitabine<br>All the patients are locally advanced breast cancer. Patients with a measurable lesion at chest CT. (at least 1 measurable lesion) | Drug: docetaxel<br>* docetaxel - 75 mg/m2, IV (in the vein), every 3 weeks, 4 cycles<br>* Other names: Doxotel®;Drug: gemcitabine<br>* gemcitabine - 100 mg/m2, IV (in the vein) on day 1 and 8 day of each 28 day cycle, 4 cycles<br>* Other names: Gemcibine®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete remission rate was assessed by pathologic examination after surgery. |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| quality of life |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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locally advanced breast cancer, docetaxel, gemcitabine