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

Locally Advanced Breast Cancer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01660542
• Other study ID #: 4-2011-0068
• Status: Completed
• Phase: Phase 4
• First received: August 5, 2012
• Last updated: October 30, 2016
• Start date: April 2011
• Est. completion date: June 2015

Study information

• Verified date: October 2016
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 70 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Locally Advanced Breast Cancer

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Severance hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathologic Complete Response	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.	26 weeks after the first administration of neoadjuvant chemotherapy with doxorubicin/cyclophosphamide regimens	No