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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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KCT |
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Last refreshed on:
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27 April 2013 |
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Main ID: |
KCT0000312 |
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Date of registration:
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05/01/2012 |
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Primary sponsor: |
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Public title:
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An Open-label, Multi-center Phase II Trial to evaluate the efficacy and Safety of Combination Chemotherapy With DoceTaxel and Gemcitabine
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Scientific title:
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An Open-label, Multi-center Phase II Trial to evaluate the efficacy and Safety of Combination Chemotherapy With DoceTaxel and Gemcitabine |
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Date of first enrolment:
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2011-12-08 |
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Target sample size:
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99 |
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Recruitment status: |
Recruiting |
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URL:
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http://cris.nih.go.kr/cris/en/search/search_result_st01.jsp?seq=1714 |
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Study type:
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Interventional Study |
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Study design:
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Primary Purpose : Treatment, Intervention Model : Single Group, Blinding/Masking : Open, Allocation : Not Applicable
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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Young-Jin
Suh |
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Address:
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Telephone:
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Email:
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Affiliation:
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The Catholic University St. Vincent's Hospital |
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Name:
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Young-Jin
Suh |
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Address:
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Telephone:
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Email:
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Affiliation:
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The Catholic University St. Vincent's Hospital |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1.pathologically proved breast cancer
2. no distant metastasis confirmed pathologically or radiologically
3. 20-70 years old female
4. ECOG performance: 0~2
5. No previous anti-cancer treatment
6. more than one lesion measurable by chest CT
7. Ample bone marrow, liver, kidney function within 2 weeks
8. Mentally sound person understanding her rights to ban the clinical trial and protocol/ ICF.
Exclusion criteria: 1. distant metastasis from breast cancer
2. HER-2 (+)
3. active cancer otherwise breast cancer (except cervix CIS or basal/squamous cell carcinoma which are properly treated)
4. Pregnancy, during lactation
5. Within 6 months, clinically significant heart problems
6. Uncontrollable systemic infection
7. male
Age minimum:
20(Year)
Age maximum:
70(Year)
Gender:
female
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Health Condition(s) or Problem(s) studied
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Neoplasms
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Intervention(s)
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Drug : objects: stage 2~3 locally advanced breast cancer (female)
chemotherapeytic agents: docetaxel(doxotel: 75mg/m2 at day 1 q 3wk) and gemcitabine(gemcibine: 1,000 mg/m2 at day 1 & 8 q 3wk)
administration: intravenous
F/U; q 2 cycles, total 4 cycles followed by curative intent operation
single group clinical study/ no control group
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Primary Outcome(s)
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pathologic complete remission
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Secondary Outcome(s)
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clinical remission rate,
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breast conserving rate
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toxicity
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Secondary ID(s)
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NCT01352494
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Source(s) of Monetary Support
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