Neoadjuvant Chemotherapy With Docetaxel and Gemcitabine in Locally Advanced Breast Cancer

Breast Cancer Stage II Clinical Trial

— NeoTG  

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01352494
• Other study ID #: KBCSG009
• Status: Unknown status
• Phase: Phase 2
• First received: May 9, 2011
• Last updated: May 25, 2011
• Start date: May 2011
• Est. completion date: May 2015

Study information

• Verified date: May 2011
• Source: Korean Breast Cancer Study Group
• Contact: Ku Sang Kim, M.D.
• Phone: 82-31-219-5200
• Email: ideakims[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 99
• Est. completion date: May 2015
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer Stage II
• Breast Cancer Stage III
• Breast Neoplasms

Intervention

Drug:
• docetaxel
docetaxel - 75 mg/m2, IV (in the vein), every 3 weeks, 4 cycles
• gemcitabine
gemcitabine - 100 mg/m2, IV (in the vein) on day 1 and 8 day of each 28 day cycle, 4 cycles

Locations

Country	Name	City	State
Korea, Republic of	Department of Surgery, the Catholic university of Korea, St. Vincent's hospital	Suwon	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Korean Breast Cancer Study Group

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete remission rate was assessed by pathologic examination after surgery.		2 years
Secondary	Type of surgery (Breast Conserving Rate)		6 month
Secondary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability		1 year
Secondary	progression free survival		2 years
Secondary	quality of life		2 years