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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2011 by Korean Breast Cancer Study Group
Sponsor:
Information provided by:
Korean Breast Cancer Study Group
ClinicalTrials.gov Identifier:
NCT01352494
First received: May 9, 2011
Last updated: May 25, 2011
Last verified: May 2011
  Purpose

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.


Condition Intervention Phase
Breast Cancer Stage II
Breast Cancer Stage III
Drug: docetaxel
Drug: gemcitabine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Korean Breast Cancer Study Group:

Primary Outcome Measures:
  • Complete remission rate was assessed by pathologic examination after surgery. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Type of surgery (Breast Conserving Rate) [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • progression free survival [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • quality of life [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 99
Study Start Date: May 2011
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Gemcibine®

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

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01352494

Contacts
Contact: Ku Sang Kim, M.D. 82-31-219-5200 ideakims@gmail.com

Locations
Korea, Republic of
Department of Surgery, the Catholic university of Korea, St. Vincent's hospital Recruiting
Suwon, Gyeonggi-do, Korea, Republic of
Contact: Young Jin Suh, M.D. Ph.D    82-31-249-7114    youngjin.suh@gmail.com   
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Young Jin Suh, Department of Surgery, the Catholic university of Korea, St. Vincent's hospital
ClinicalTrials.gov Identifier: NCT01352494     History of Changes
Other Study ID Numbers: KBCSG009
Study First Received: May 9, 2011
Last Updated: May 25, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by Korean Breast Cancer Study Group:
locally advanced breast cancer
docetaxel
gemcitabine

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Gemcitabine
Docetaxel
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on October 01, 2014