Neoadjuvant Chemotherapy With Docetaxel and Gemcitabine in Locally Advanced Breast Cancer (NeoTG)
This study is not yet open for participant recruitment.
Verified May 2011 by Korean Breast Cancer Study Group
Sponsor:
Korean Breast Cancer Study Group
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
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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:
- 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.
Contacts and Locations
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 |
ClinicalTrials.gov processed this record on May 23, 2013