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Primary Chemotherapy With Anthracycline Followed by Nab-paclitaxel and Trastuzumab

This study has been completed.
Information provided by (Responsible Party):
Satoru Tanaka, Osaka Medical College Identifier:
First received: September 8, 2011
Last updated: April 21, 2015
Last verified: April 2015
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.

Condition Intervention Phase
Breast Cancer
HER-2 Positive Breast Cancer
Effects of Chemotherapy
Drug: Nab-paclitaxel
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Primary Chemotherapy With Anthracycline-based Regimen Followed by Nab-paclitaxel and Trastuzumab in Patients With HER2 Positive Breast Cancer

Resource links provided by NLM:

Further study details as provided by Osaka Medical College:

Primary Outcome Measures:
  • To evaluate the pathological complete response rate [ Time Frame: 1 year from last patient enrolled ]

Secondary Outcome Measures:
  • Disease free survival [ Time Frame: 5 years from the last patient enrolled ]
  • Overall response rate [ Time Frame: After the protocol therapy ]
  • Pathological response rate [ Time Frame: After the protocol therapy ]
  • Breast-conserving surgery rate [ Time Frame: After the protocol therapy ]
  • Safety [ Time Frame: Within the protocol thepapy ]

Enrollment: 46
Study Start Date: September 2011
Study Completion Date: May 2014
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nab-paclitaxel
Nab-paclitaxel q3w 260mg/m2
Drug: Nab-paclitaxel
Nab-paclitaxel 260mg/m2 q3w
Other Name: Abraxane

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.


Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01432223

Osaka Medical College
Takatsuki, Osaka, Japan, 5698686
Sponsors and Collaborators
Osaka Medical College
Principal Investigator: Mitsuhiko Iwamoto, MD, PhD Osaka Medical College
  More Information

Responsible Party: Satoru Tanaka, MD, PhD, Osaka Medical College Identifier: NCT01432223     History of Changes
Other Study ID Numbers: OMC-BC01
UMIN000006288 ( Registry Identifier: University hospital Medical Information Network )
Study First Received: September 8, 2011
Last Updated: April 21, 2015

Keywords provided by Osaka Medical College:
Neoadjuvant chemotherapy
Primary chemotherapy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action processed this record on April 28, 2017