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

NCT ID: NCT01660542

Last Updated: 2016-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2015-06-30

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.

Conditions

Locally Advanced Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

doxorubicin/cyclophosphamide

Neoadjuvant Chemotherapy with Docetaxel(Monotaxel®) after Doxorubicin plus Cyclophosphamide

Group Type: EXPERIMENTAL

Neoadjuvant Chemotherapy with Docetaxel

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Severance hospital

Seoul, Seoul, South Korea

Countries

South Korea

Other Identifiers

4-2011-0068

Identifier Type: -

Identifier Source: org_study_id