Primary Chemotherapy With Anthracycline Followed by Nab-paclitaxel and Trastuzumab

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Satoru Tanaka, Osaka Medical College
ClinicalTrials.gov Identifier:
NCT01432223
First received: September 8, 2011
Last updated: January 28, 2014
Last verified: January 2014
  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: Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Disease free survival [ Time Frame: 5 years from the last patient enrolled ] [ Designated as safety issue: No ]
  • Overall response rate [ Time Frame: After the protocol therapy ] [ Designated as safety issue: No ]
  • Pathological response rate [ Time Frame: After the protocol therapy ] [ Designated as safety issue: No ]
  • Breast-conserving surgery rate [ Time Frame: After the protocol therapy ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: Within the protocol thepapy ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 45
Study Start Date: September 2011
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (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

Ages Eligible for Study:   20 Years to 70 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Satoru Tanaka, MD, PhD, Osaka Medical College
ClinicalTrials.gov Identifier: NCT01432223     History of Changes
Other Study ID Numbers: OMC-BC01, UMIN000006288
Study First Received: September 8, 2011
Last Updated: January 28, 2014
Health Authority: Japan: Institutional Review Board

Keywords provided by Osaka Medical College:
Trastuzumab
Neoadjuvant chemotherapy
Primary chemotherapy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Trastuzumab
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 14, 2014