Neoadjuvant Chemotherapy With Docetaxel and Gemcitabine in Locally Advanced Breast Cancer

Phase 2

• Conditions: Breast Cancer Stage II; Breast Cancer Stage III
• Interventions: Drug: docetaxel; Drug: gemcitabine

• Registration Number: NCT01352494
• Lead Sponsor: Korean Breast Cancer Study Group

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2011-05
• Study Start: 2011-05
• Study First Submitted: 2011-05-09
• Study First Submitted QC: 2011-05-10
• Study First Posted: 2011-05-12
• Last Update Submitted: 2011-05-25
• Last Update Posted: 2011-05-27
• Primary Completion: 2013-05
• Study Completion: 2015-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 99

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
docetaxel/gemcitabine	docetaxel	All the patients are locally advanced breast cancer. Patients with a measurable lesion at chest CT. (at least 1 measurable lesion)
docetaxel/gemcitabine	gemcitabine	All the patients are locally advanced breast cancer. Patients with a measurable lesion at chest CT. (at least 1 measurable lesion)

Primary Outcome Measures

Name	Time	Method
Complete remission rate was assessed by pathologic examination after surgery.	2 years

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Surgery, the Catholic university of Korea, St. Vincent's hospital; 🇰🇷 Suwon, Gyeonggi-do, Korea, Republic of