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Primary Chemotherapy With Anthracycline Followed by Nab-paclitaxel and Trastuzumab

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01432223
First Posted: September 12, 2011
Last Update Posted: April 22, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Satoru Tanaka, Osaka Medical College
  Purpose
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: None (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 Satoru Tanaka, 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.

  Eligibility

Information from the National Library of Medicine

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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01432223


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

Publications:
Responsible Party: Satoru Tanaka, MD, PhD, Osaka Medical College
ClinicalTrials.gov Identifier: NCT01432223     History of Changes
Other Study ID Numbers: OMC-BC01
UMIN000006288 ( Registry Identifier: University hospital Medical Information Network )
First Submitted: September 8, 2011
First Posted: September 12, 2011
Last Update Posted: April 22, 2015
Last Verified: April 2015

Keywords provided by Satoru Tanaka, Osaka Medical College:
Trastuzumab
Neoadjuvant chemotherapy
Primary chemotherapy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Trastuzumab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action