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. (see Contacts and Locations)
Verified February 2014 by Yonsei University
Information provided by (Responsible Party):
Yonsei University Identifier:
First received: August 5, 2012
Last updated: February 17, 2014
Last verified: February 2014
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.

Condition Intervention Phase
Locally Advanced Breast Cancer
Drug: Neoadjuvant Chemotherapy with Docetaxel
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • 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.

Estimated Enrollment: 95
Study Start Date: May 2011
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: doxorubicin/cyclophosphamide
Neoadjuvant Chemotherapy with Docetaxel(Monotaxel®) after Doxorubicin plus Cyclophosphamide
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


Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01660542

Korea, Republic of
Severance hospital Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Se Ho Park, MD    82-2-2228-2134   
Principal Investigator: Byeong-Woo Park, MD, PhD         
Sponsors and Collaborators
Yonsei University
  More Information

No publications provided

Responsible Party: Yonsei University Identifier: NCT01660542     History of Changes
Other Study ID Numbers: 4-2011-0068 
Study First Received: August 5, 2012
Last Updated: February 17, 2014
Health Authority: South Korea: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms by Site
Skin Diseases
Liposomal doxorubicin
Alkylating Agents
Antibiotics, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Tubulin Modulators processed this record on February 11, 2016