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Neoadjuvant Chemotherapy With Docetaxel and Gemcitabine in Locally Advanced Breast Cancer (NeoTG)

Primary Purpose

Breast Cancer Stage II, Breast Cancer Stage III

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
docetaxel
gemcitabine
Sponsored by
Korean Breast Cancer Study Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer Stage II focused on measuring locally advanced breast cancer, docetaxel, gemcitabine

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Surgery, the Catholic university of Korea, St. Vincent's hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

docetaxel/gemcitabine

Arm Description

All the patients are locally advanced breast cancer. Patients with a measurable lesion at chest CT. (at least 1 measurable lesion)

Outcomes

Primary Outcome Measures

Complete remission rate was assessed by pathologic examination after surgery.

Secondary Outcome Measures

Type of surgery (Breast Conserving Rate)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
progression free survival
quality of life

Full Information

First Posted
May 9, 2011
Last Updated
May 25, 2011
Sponsor
Korean Breast Cancer Study Group
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1. Study Identification

Unique Protocol Identification Number
NCT01352494
Brief Title
Neoadjuvant Chemotherapy With Docetaxel and Gemcitabine in Locally Advanced Breast Cancer
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Unknown status
Study Start Date
May 2011 (undefined)
Primary Completion Date
May 2013 (Anticipated)
Study Completion Date
May 2015 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Korean Breast Cancer Study Group

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Stage II, Breast Cancer Stage III
Keywords
locally advanced breast cancer, docetaxel, gemcitabine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
99 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
docetaxel/gemcitabine
Arm Type
Experimental
Arm Description
All the patients are locally advanced breast cancer. Patients with a measurable lesion at chest CT. (at least 1 measurable lesion)
Intervention Type
Drug
Intervention Name(s)
docetaxel
Other Intervention Name(s)
Doxotel®
Intervention Description
docetaxel - 75 mg/m2, IV (in the vein), every 3 weeks, 4 cycles
Intervention Type
Drug
Intervention Name(s)
gemcitabine
Other Intervention Name(s)
Gemcibine®
Intervention Description
gemcitabine - 100 mg/m2, IV (in the vein) on day 1 and 8 day of each 28 day cycle, 4 cycles
Primary Outcome Measure Information:
Title
Complete remission rate was assessed by pathologic examination after surgery.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Type of surgery (Breast Conserving Rate)
Time Frame
6 month
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame
1 year
Title
progression free survival
Time Frame
2 years
Title
quality of life
Time Frame
2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ku Sang Kim, M.D.
Phone
82-31-219-5200
Email
ideakims@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Young Jin Suh, M.D. Ph.D
Organizational Affiliation
Department of Surgery, the Catholic university of Korea, St. Vincent's hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Surgery, the Catholic university of Korea, St. Vincent's hospital
City
Suwon
State/Province
Gyeonggi-do
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Young Jin Suh, M.D. Ph.D
Phone
82-31-249-7114
Email
youngjin.suh@gmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
29285038
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.
Results Reference
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Neoadjuvant Chemotherapy With Docetaxel and Gemcitabine in Locally Advanced Breast Cancer

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