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

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ClinicalTrials.gov Identifier: NCT01352494
Recruitment Status : Unknown
Verified May 2011 by Korean Breast Cancer Study Group.
Recruitment status was:  Not yet recruiting
First Posted : May 12, 2011
Last Update Posted : May 27, 2011
Sponsor:
Information provided by:
Korean Breast Cancer Study Group

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Stage II Breast Cancer Stage III Drug: docetaxel Drug: gemcitabine Phase 2

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  (Clinical Trial)
Estimated Enrollment : 99 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : May 2011
Estimated Primary Completion Date : May 2013
Estimated Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

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 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®



Primary Outcome Measures :
  1. Complete remission rate was assessed by pathologic examination after surgery. [ Time Frame: 2 years ]

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


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Posted: May 12, 2011    Key Record Dates
Last Update Posted: May 27, 2011
Last Verified: May 2011

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
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators