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

May 25, 2011 updated by: Korean Breast Cancer Study Group

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

99

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
quality of life
Time Frame: 2 years
2 years
progression free survival
Time Frame: 2 years
2 years
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame: 1 year
1 year
Type of surgery (Breast Conserving Rate)
Time Frame: 6 month
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Korean Breast Cancer Study Group

Investigators

  • Principal Investigator: Young Jin Suh, M.D. Ph.D, Department of Surgery, the Catholic university of Korea, St. Vincent's hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Anticipated)

May 1, 2013

Study Completion (Anticipated)

May 1, 2015

Study Registration Dates

First Submitted

May 9, 2011

First Submitted That Met QC Criteria

May 10, 2011

First Posted (Estimate)

May 12, 2011

Study Record Updates

Last Update Posted (Estimate)

May 27, 2011

Last Update Submitted That Met QC Criteria

May 25, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KBCSG009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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