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

NCT01660542 | Completed Phase 4

• 1 other identifier: 4-2011-0068
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

doxorubicin/cyclophosphamide

EXPERIMENTAL

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

Drug: Neoadjuvant Chemotherapy with Docetaxel

Interventions

Neoadjuvant Chemotherapy with Docetaxel 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

doxorubicin/cyclophosphamide

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• patients with evidence of distant metastases
• patients with other previous malignancy except breast cancer
• pregnant (positive hCG test 1 week before registration) or lactating patient
• uncontrolled serious infection
• patients with psychiatric disease or epilepsy
• patients with clinically severe cardiac disease within 6 months such as atrial or ventricular arrhythmia, congestive heart failure, myocardial infarction, or unstable angina
• male breast cancer
• patients with poor general condition who are not able to understand or sign the written informed consent

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance hospital

Seoul, Seoul, 120-752, South Korea

Location

MeSH Terms

Interventions

Neoadjuvant Therapy; Docetaxel

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2012
• First Posted: August 8, 2012
• Study Start: April 1, 2011
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: November 1, 2016

Record last verified: 2016-10

Locations

KR (1)