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Completed

NCT Number: NCT01432223

Primary Chemotherapy With Anthracycline Followed by Nab-paclitaxel and Trastuzumab

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.

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Key information

Age range

20 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Osaka Medical College

Takatsuki, Osaka, 5698686, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nab-paclitaxel

Drug

Nab-paclitaxel 260mg/m2 q3w

Other names: Abraxane

Primary outcomes

  1. To evaluate the pathological complete response rate

    Time frame: 1 year from last patient enrolled

Secondary outcomes

  1. Disease free survival

    Time frame: 5 years from the last patient enrolled

  2. Overall response rate

    Time frame: After the protocol therapy

  3. Pathological response rate

    Time frame: After the protocol therapy

  4. Breast-conserving surgery rate

    Time frame: After the protocol therapy

  5. Safety

    Time frame: Within the protocol thepapy

Sponsors and collaborators

Lead sponsor

Osaka Medical College

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Sep 12, 2011
Registry last updated
Apr 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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