NCT01432223

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for phase_2 breast-cancer

Timeline
Completed

Started Sep 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 8, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2011

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

April 22, 2015

Status Verified

April 1, 2015

Enrollment Period

2.2 years

First QC Date

September 8, 2011

Last Update Submit

April 21, 2015

Conditions

Breast CancerHER-2 Positive Breast CancerEffects of Chemotherapy

Keywords

TrastuzumabNeoadjuvant chemotherapyPrimary chemotherapy

Outcome Measures

Primary Outcomes (1)

  • To evaluate the pathological complete response rate

    1 year from last patient enrolled

Secondary Outcomes (5)

  • Disease free survival

    5 years from the last patient enrolled

  • Overall response rate

    After the protocol therapy

  • Pathological response rate

    After the protocol therapy

  • Breast-conserving surgery rate

    After the protocol therapy

  • Safety

    Within the protocol thepapy

Study Arms (1)

Nab-paclitaxel

EXPERIMENTAL

Nab-paclitaxel q3w 260mg/m2

Drug: Nab-paclitaxel

Interventions

Nab-paclitaxelDRUG

Nab-paclitaxel 260mg/m2 q3w

Also known as: Abraxane
Nab-paclitaxel

Eligibility Criteria

Age20 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Osaka Medical College

Takatsuki, Osaka, 5698686, Japan

Location

Related Publications (1)

  • Tanaka S, Iwamoto M, Kimura K, Matsunami N, Morishima H, Yoshidome K, Nomura T, Morimoto T, Yamamoto D, Tsubota Y, Kobayashi T, Uchiyama K. Phase II Study of Neoadjuvant Anthracycline-Based Regimens Combined With Nanoparticle Albumin-Bound Paclitaxel and Trastuzumab for Human Epidermal Growth Factor Receptor 2-Positive Operable Breast Cancer. Clin Breast Cancer. 2015 Jun;15(3):191-6. doi: 10.1016/j.clbc.2014.12.003. Epub 2014 Dec 24.

    PMID: 25579459RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

130-nm albumin-bound paclitaxelAlbumin-Bound Paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

PaclitaxelTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesAlbuminsProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Mitsuhiko Iwamoto, MD, PhD

    Osaka Medical College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

September 8, 2011

First Posted

September 12, 2011

Study Start

September 1, 2011

Primary Completion

November 1, 2013

Study Completion

May 1, 2014

Last Updated

April 22, 2015

Record last verified: 2015-04

Locations

JP(1)