Clinical trial NCT01352494: Neoadjuvant Chemotherapy With Docetaxel and Gemcitabine in Locally Advanced Breast Cancer
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Breast Cancer Stage II
Breast Cancer Stage III
Keywords: locally advanced breast cancer
docetaxel
gemcitabine
Lead sponsor: Korean Breast Cancer Study Group
Sponsor class: OTHER
First posted: 2011-05-12
Enrollment: 99
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Complete remission rate was assessed by pathologic examination after surgery.
timeFrame: 2 years
Secondary outcomes:
measure: Type of surgery (Breast Conserving Rate)
timeFrame: 6 month
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: 1 year
measure: progression free survival
timeFrame: 2 years
measure: quality of life
timeFrame: 2 years
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Department of Surgery, the Catholic university of Korea, St. Vincent's hospital
state: Gyeonggi-do
Study officials:
affiliation: Department of Surgery, the Catholic university of Korea, St. Vincent's hospital
name: Young Jin Suh, M.D. Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jeon YW, Kim TH, Youn HJ, Han S, Jung Y, Gwak G, Park YS, Kim JS, Suh YJ. A Multicenter Phase II Trial of Neoadjuvant Chemotherapy with Docetaxel and Gemcitabine in Locally Advanced Breast Cancer. J Breast Cancer. 2017 Dec;20(4):340-346. doi: 10.4048/jbc.2017.20.4.340. Epub 2017 Dec 19.