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Neoadjuvant Nab-PTX and Trastuzumab for ER Negative and HER2 Positive Breast Cancer

Primary Purpose

Breast Cancer, Estrogen Receptor Negative Neoplasm, HER-2 Positive Breast Cancer

Status
Terminated
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
nab-paclitaxel
Trastuzumab
Sponsored by
Osaka Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Histologically confirmed invasive breast cancer
  2. Tumor size of 3cm or less and N0
  3. Hormone receptors have been identified as negative
  4. HER2 positive confirmed by IHC 3+ or FISH+
  5. LVEF > 50% by echocardiogram or MUGA
  6. Adequate EKG
  7. No prior treatment for breast cancer
  8. PS 0-1
  9. 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
  10. Written informed consent

Exclusion Criteria:

  1. With history of hypersensitivity reaction for important drug in this study
  2. With history of invasive breast cancer
  3. Bilateral invasive breast cancer
  4. Patients with medical conditions that renders them intolerant to primary chemotherapy and related treatment, including infection, diarrhea, intestinal paralysis, severe Diabetes Mellitus
  5. Positive for HBs antigen or HCV antibody
  6. With history of congestive heart failure, uncontrolled or symptomatic angina pectoris, arrhythmia or myocardial infarction, poorly controlled hypertension
  7. With severe edema
  8. With severe peripheral neuropathy
  9. With severe psychiatric disorder
  10. Pregnant or nursing women
  11. The case that is judged to be unsuitable for this study by physician

Sites / Locations

  • Osaka Medical College

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

nab-paclitaxel plus trastuzumab

Arm Description

Four cycles of nab-PTX 260 mg/m2 with trastuzumab 6 mg/kg (8 mg/kg as the loading dose). One year of adjuvant trastuzumab will be administrated. Anthracycline regimens may be administered by physician's choice for the case expected to have a high risk of recurrence based on the pathological findings of surgical specimen. Adjuvant endocrine therapy may be administrated for the case with weakly hormone-sensitive (1-9% of positive cells) tumor.

Outcomes

Primary Outcome Measures

Pathological complete response rate

Secondary Outcome Measures

Disease free survival
Objective response rate
Pathological response rate
Breast-conserving surgery rate
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Full Information

First Posted
November 2, 2015
Last Updated
August 26, 2019
Sponsor
Osaka Medical College
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1. Study Identification

Unique Protocol Identification Number
NCT02598310
Brief Title
Neoadjuvant Nab-PTX and Trastuzumab for ER Negative and HER2 Positive Breast Cancer
Official Title
Phase II Study of Neoadjuvant Nab-paclitaxel (PTX) and Trastuzumab for ER Negative and HER2 Positive Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Terminated
Study Start Date
November 2015 (Actual)
Primary Completion Date
November 30, 2018 (Actual)
Study Completion Date
November 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Osaka Medical College

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy and safety of nab-PTX and trastuzumab for ER negative and HER2 positive operable (tumor size of 3cm or less and N0) breast cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Estrogen Receptor Negative Neoplasm, HER-2 Positive Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
nab-paclitaxel plus trastuzumab
Arm Type
Experimental
Arm Description
Four cycles of nab-PTX 260 mg/m2 with trastuzumab 6 mg/kg (8 mg/kg as the loading dose). One year of adjuvant trastuzumab will be administrated. Anthracycline regimens may be administered by physician's choice for the case expected to have a high risk of recurrence based on the pathological findings of surgical specimen. Adjuvant endocrine therapy may be administrated for the case with weakly hormone-sensitive (1-9% of positive cells) tumor.
Intervention Type
Drug
Intervention Name(s)
nab-paclitaxel
Other Intervention Name(s)
Abraxane
Intervention Description
nab-paclitaxel 260mg/m2 q3w
Intervention Type
Drug
Intervention Name(s)
Trastuzumab
Other Intervention Name(s)
Herceptin
Intervention Description
trastuzumab 6 mg/kg (8 mg/kg as the loading dose)
Primary Outcome Measure Information:
Title
Pathological complete response rate
Time Frame
Up to 12 weeks after the protocol therapy
Secondary Outcome Measure Information:
Title
Disease free survival
Time Frame
Five years after the last patient enrolled
Title
Objective response rate
Time Frame
Up to 6 weeks after the protocol therapy
Title
Pathological response rate
Time Frame
Up to 12 weeks after the protocol therapy
Title
Breast-conserving surgery rate
Time Frame
Up to 6 weeks after the protocol therapy
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame
Up to 6 weeks after the protocol therapy

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed invasive breast cancer Tumor size of 3cm or less and N0 Hormone receptors have been identified as negative 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 or HCV antibody 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 The case that is judged to be unsuitable for this study by physician
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mitsuhiko Iwamoto, MD, PhD
Organizational Affiliation
Osaka Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Osaka Medical College
City
Takatsuki
State/Province
Osaka
ZIP/Postal Code
5698686
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
30963212
Citation
Tanaka S, Matsunami N, Morishima H, Oda N, Takashima T, Noda S, Kashiwagi S, Tauchi Y, Asano Y, Kimura K, Fujioka H, Terasawa R, Kawaguchi K, Ikari A, Morimoto T, Michishita S, Kobayashi T, Sakane J, Nitta T, Sato N, Hokimoto N, Nishida Y, Iwamoto M. De-escalated neoadjuvant therapy with nanoparticle albumin-bound paclitaxel and trastuzumab for low-risk pure HER2 breast cancer. Cancer Chemother Pharmacol. 2019 Jun;83(6):1099-1104. doi: 10.1007/s00280-019-03836-z. Epub 2019 Apr 8.
Results Reference
derived

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Neoadjuvant Nab-PTX and Trastuzumab for ER Negative and HER2 Positive Breast Cancer

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