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 2014 by Yonsei University
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01660542
First received: August 5, 2012
Last updated: February 17, 2014
Last verified: February 2014

August 5, 2012
February 17, 2014
May 2011
May 2016   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01660542 on ClinicalTrials.gov Archive Site
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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
Not Provided

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.

Not Provided
Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Locally Advanced Breast Cancer
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
Experimental: doxorubicin/cyclophosphamide
Neoadjuvant Chemotherapy with Docetaxel(Monotaxel®) after Doxorubicin plus Cyclophosphamide
Intervention: Drug: Neoadjuvant Chemotherapy with Docetaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
95
May 2016
May 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Patients with histologically proven invasive breast cancer - the primary tumor size is at least 5cm or cytologically proven axillary node metastasis
  2. no evidence of systemic metastasis pathologically or radiologically
  3. age at the time of diagnosis between 20 and 70 years
  4. patients with previously untreated primary breast cancer including chemotherapy
  5. general performance status with ECOG 0-2
  6. sufficient hematopoietic function (absolute neutrophil count of ≥ 1,500/mm3, platelet count of ≥ 100,000/mm3, and hemoglobin of ≥ 10 g/dL)
  7. sufficient renal function (serum creatinine level of ≤ 1.5 mg/dL)
  8. 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)
  9. sufficient cardiac function (normal electrocardiography within 1 month or LVEF>50% by echocardiography or MUGA scan within 3 months)
  10. patients who agree to enroll this clinical trial and sign the written informed consent voluntarily

Exclusion Criteria:

  1. patients with evidence of distant metastases
  2. patients with other previous malignancy except breast cancer
  3. pregnant (positive hCG test 1 week before registration) or lactating patient
  4. uncontrolled serious infection
  5. patients with psychiatric disease or epilepsy
  6. patients with clinically severe cardiac disease within 6 months such as atrial or ventricular arrhythmia, congestive heart failure, myocardial infarction, or unstable angina
  7. male breast cancer
  8. patients with poor general condition who are not able to understand or sign the written informed consent
Female
20 Years to 70 Years
No
Not Provided
Korea, Republic of
 
NCT01660542
4-2011-0068
No
Yonsei University
Yonsei University
Not Provided
Not Provided
Yonsei University
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP