An Open-label, Multi-center Phase Ⅳ Trial to Evaluate the Efficacy and Safety of Sequential Neoadjuvant Chemotherapy With Docetaxel(Monotaxel®) After Doxorubicin Plus Cyclophosphamide Combination Chemotherapy in Locally Advanced Breast Cancer

This study is currently recruiting participants.

Verified February 2013 by Yonsei University

Sponsor:

Information provided by (Responsible Party):

Yonsei University

ClinicalTrials.gov Identifier:

NCT01660542

First received: August 5, 2012

Last updated: February 26, 2013

Last verified: February 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	August 5, 2012
Last Updated Date	February 26, 2013
Start Date ^ICMJE	May 2011
Estimated Primary Completion Date	May 2016 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 7, 2012)	Pathologic Complete Response [ Time Frame: 26 weeks after the first administration of neoadjuvant chemotherapy with doxorubicin/cyclophosphamide regimens ] [ Designated as safety issue: No ] Pathologic complete response is defined as the disappearance of all invasive cancer in the postsurgical breast and lymph node specimens after completion of neoadjuvant chemotherapy. Only residual intraductal carcinoma in the postsurgical breast specimen after neoadjuvant chemotherapy is also considered as the achievement of pathologic complete response.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01660542 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	An Open-label, Multi-center Phase Ⅳ Trial to Evaluate the Efficacy and Safety of Sequential Neoadjuvant Chemotherapy With Docetaxel(Monotaxel®) After Doxorubicin Plus Cyclophosphamide Combination Chemotherapy in Locally Advanced Breast Cancer
Official Title ^ICMJE	Not Provided
Brief Summary	This is a multicenter, open-label, phase IV trial to assess the efficacy and safety of sequential neoadjuvant chemotherapy with 4 cycles of doxorubicin/cyclophosphamide followed by 4 cycles of docetaxel(Monotaxel®) in patients with breast cancer of ≥5cm in size or cytologically confirmed axillary lymph nodes metastasis.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Locally Advanced Breast Cancer
Intervention ^ICMJE	Drug: Neoadjuvant Chemotherapy with Docetaxel Doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m2 (day 1), IV (in the vein), every 21 days, a total of 4 cycles -> Docetaxel 100 mg/m2 (day 1) IV, every 21 days, a total of 4 cycles
Study Arm (s)	Experimental: doxorubicin/cyclophosphamide Neoadjuvant Chemotherapy with Docetaxel(Monotaxel®) after Doxorubicin plus Cyclophosphamide Intervention: Drug: Neoadjuvant Chemotherapy with Docetaxel
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	95
Estimated Completion Date	May 2016
Estimated Primary Completion Date	May 2016 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Patients with histologically proven invasive breast cancer - the primary tumor size is at least 5cm or cytologically proven axillary node metastasis no evidence of systemic metastasis pathologically or radiologically age at the time of diagnosis between 20 and 70 years patients with previously untreated primary breast cancer including chemotherapy general performance status with ECOG 0-2 sufficient hematopoietic function (absolute neutrophil count of ≥ 1,500/mm3, platelet count of ≥ 100,000/mm3, and hemoglobin of ≥ 10 g/dL) sufficient renal function (serum creatinine level of ≤ 1.5 mg/dL) sufficient liver function (total serum bilirubin level ≤ 1.5 times the upper normal limit; serum AST and ALT levels ≤ 1.5 times the upper normal limit; and serum alkaline phosphatase level ≤ 1.5 times the upper normal limit) sufficient cardiac function (normal electrocardiography within 1 month or LVEF>50% by echocardiography or MUGA scan within 3 months) patients who agree to enroll this clinical trial and sign the written informed consent voluntarily Exclusion Criteria: patients with evidence of distant metastases patients with other previous malignancy except breast cancer pregnant (positive hCG test 1 week before registration) or lactating patient uncontrolled serious infection patients with psychiatric disease or epilepsy patients with clinically severe cardiac disease within 6 months such as atrial or ventricular arrhythmia, congestive heart failure, myocardial infarction, or unstable angina male breast cancer patients with poor general condition who are not able to understand or sign the written informed consent
Gender	Female
Ages	20 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Korea, Republic of

Administrative Information
NCT Number ^ICMJE	NCT01660542
Other Study ID Numbers ^ICMJE	4-2011-0068
Has Data Monitoring Committee	No
Responsible Party	Yonsei University
Study Sponsor ^ICMJE	Yonsei University
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Yonsei University
Verification Date	February 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top