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

Phase 4

Completed

• Conditions: Locally Advanced Breast Cancer
• Interventions: Drug: Neoadjuvant Chemotherapy with Docetaxel

• Registration Number: NCT01660542
• Lead Sponsor: Yonsei University

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 available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2012-08-05
• Study First Submitted QC: 2012-08-07
• Study First Posted: 2012-08-08
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-30
• Last Update Posted: 2016-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 96

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
doxorubicin/cyclophosphamide	Neoadjuvant Chemotherapy with Docetaxel	Neoadjuvant Chemotherapy with Docetaxel(Monotaxel®) after Doxorubicin plus Cyclophosphamide

Primary Outcome Measures

Name	Time	Method
Pathologic Complete Response	26 weeks after the first administration of neoadjuvant chemotherapy with doxorubicin/cyclophosphamide regimens	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.

Trial Locations

Locations (1)

Severance hospital; 🇰🇷 Seoul, Korea, Republic of