Primary Chemotherapy With Anthracycline Followed by Nab-paclitaxel and Trastuzumab

Phase 2

Completed

• Conditions: Breast Cancer; HER-2 Positive Breast Cancer; Effects of Chemotherapy
• Interventions: Drug: Nab-paclitaxel

• Registration Number: NCT01432223
• Lead Sponsor: Osaka Medical College

Brief Summary

The purpose of this study is to evaluate the efficacy in terms of the pathological complete response (pCR) rate and the efficacy to preoperative administration of Anthracycline-based regimen followed by Nab-paclitaxel and Trastuzumab in patients with HER2 positive operable breast cancer.

Detailed Description

Four cycles of anthracycline-based regimen followed by four cycles of Nab-paclitaxel and Trastuzumab are administrated.

Anthracycline-based regimen (d1, q3w):

EC (Epirubicin 90mg/m2 and Cyclophosphamide 600mg/m2) AC (Doxorubicin 60mg/m2 and Cyclophosphamide 600mg/m2) FEC (Fluorouracil 500mg/m2, Epirubicin 100mg/m2 and Cyclophosphamide 500mg/m2)

Nab-paclitaxel 260mg/m2 (d1, q3w)

Trastuzumab (d1, q3w) is given at a dose of 8 mg/kg IV on day 1 of the first treatment cycle over 90 min, and subsequently given at a dose of 6 mg/kg over 30 min.

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-09-08
• Study First Submitted QC: 2011-09-09
• Study First Posted: 2011-09-12
• Primary Completion: 2013-11
• Study Completion: 2014-05
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-21
• Last Update Posted: 2015-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 46

Inclusion Criteria

• Histologically confirmed invasive breast cancer
• T1c-3 N0-2a
• Confirmed of hormonal receptor status
• HER2 positive confirmed by IHC 3+ or FISH+
• LVEF > 50% by echocardiogram or MUGA
• Adequate EKG
• No prior treatment for breast cancer
• PS 0-1
• Required baseline laboratory data WBC > 4,000/mm3 and Neut > 2,000/mm3 PLT > 100,000/mm3 Hb > 9.0g/dl AST and ALT < ULNx2.5 T-Bil < 1.5mg/dl Serum creatinin < 1.5mg/dl
• Written informed consent

Exclusion Criteria

• With history of hypersensitivity reaction for important drug in this study
• With history of invasive breast cancer
• Bilateral invasive breast cancer
• Patients with medical conditions that renders them intolerant to primary chemotherapy and related treatment, including infection, diarrhea, intestinal paralysis, severe Diabetes Mellitus
• Positive for HBs antigen and with history of HVB
• With history of congestive heart failure, uncontrolled or symptomatic angina pectoris, arrhythmia or myocardial infarction, poorly controlled hypertension
• With severe edema
• With severe peripheral neuropathy
• With severe psychiatric disorder
• Pregnant or nursing women
• Cases who physician judged improper to entry this trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nab-paclitaxel	Nab-paclitaxel	Nab-paclitaxel q3w 260mg/m2

Primary Outcome Measures

Name	Time	Method
To evaluate the pathological complete response rate	1 year from last patient enrolled

Secondary Outcome Measures

Name	Time	Method
Overall response rate	After the protocol therapy
Disease free survival	5 years from the last patient enrolled
Breast-conserving surgery rate	After the protocol therapy
Safety	Within the protocol thepapy
Pathological response rate	After the protocol therapy

Trial Locations

Locations (1)

Osaka Medical College; 🇯🇵 Takatsuki, Osaka, Japan