Primary Chemotherapy With Anthracycline Followed by Nab-paclitaxel and Trastuzumab

This study is currently recruiting participants.

Verified September 2011 by Osaka Medical College

Sponsor:

Information provided by (Responsible Party):

Satoru Tanaka, Osaka Medical College

ClinicalTrials.gov Identifier:

NCT01432223

First received: September 8, 2011

Last updated: September 9, 2011

Last verified: September 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

September 8, 2011

Last Updated Date

September 9, 2011

Start Date ^ICMJE

September 2011

Estimated Primary Completion Date

August 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To evaluate the pathological complete response rate [ Time Frame: 1 year from last patient enrolled ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01432223 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To evaluate the overall response rate [ Time Frame: 1 year from last patient enrolled ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Primary Chemotherapy With Anthracycline Followed by Nab-paclitaxel and Trastuzumab

Official Title ^ICMJE

Phase II Study of Primary Chemotherapy With Anthracycline-based Regimen Followed by Nab-paclitaxel and Trastuzumab in Patients With HER2 Positive Breast Cancer

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 Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Breast Cancer
HER-2 Positive Breast Cancer
Effects of Chemotherapy

Intervention ^ICMJE

Drug: Nab-paclitaxel

Nab-paclitaxel 260mg/m2 q3w

Other Name: Abraxane

Study Arm (s)

Experimental: Nab-paclitaxel

Intervention: Drug: Nab-paclitaxel

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

August 2014

Estimated Primary Completion Date

August 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

20 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Satoru Tanaka, MD, PhD		sur112@poh.osaka-med.ac.jp
Contact: Mitsuhiko Iwamoto, MD, PhD		sur067@poh.osaka-med.ac.jp

Location Countries ^ICMJE

Japan

Administrative Information

NCT Number ^ICMJE

NCT01432223

Other Study ID Numbers ^ICMJE

OMC-BC01, UMIN000006288

Has Data Monitoring Committee

Yes

Responsible Party

Satoru Tanaka, Osaka Medical College

Study Sponsor ^ICMJE

Osaka Medical College

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Mitsuhiko Iwamoto, MD, PhD

Osaka Medical College

Information Provided By

Osaka Medical College

Verification Date

September 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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