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

Phase II Study of Neoadjuvant Nab-paclitaxel (PTX) and Trastuzumab for ER Negative and HER2 Positive Breast Cancer

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.

Study Overview

• Status: Terminated
• Conditions: Breast Cancer; HER-2 Positive Breast Cancer; Estrogen Receptor Negative Neoplasm
• Intervention / Treatment: Drug: nab-paclitaxel; Drug: Trastuzumab

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• Japan
  • Osaka
    • Takatsuki, Osaka, Japan, 5698686
      • Osaka Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: nab-paclitaxel plus trastuzumab; 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.

Drug: nab-paclitaxel; nab-paclitaxel 260mg/m2 q3w; Other Names: Abraxane; Drug: Trastuzumab; trastuzumab 6 mg/kg (8 mg/kg as the loading dose); Other Names: Herceptin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pathological complete response rate	Up to 12 weeks after the protocol therapy

Secondary Outcome Measures

Outcome Measure	Time Frame
Disease free survival	Five years after the last patient enrolled
Objective response rate	Up to 6 weeks after the protocol therapy
Pathological response rate	Up to 12 weeks after the protocol therapy
Breast-conserving surgery rate	Up to 6 weeks after the protocol therapy
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	Up to 6 weeks after the protocol therapy

Collaborators and Investigators

• Sponsor: Osaka Medical College
• Investigators: Principal Investigator: Mitsuhiko Iwamoto, MD, PhD, Osaka Medical College

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2015
• Primary Completion (Actual): November 30, 2018
• Study Completion (Actual): November 30, 2018

Study Registration Dates

• First Submitted: November 2, 2015
• First Submitted That Met QC Criteria: November 4, 2015
• First Posted (Estimate): November 5, 2015

Study Record Updates

• Last Update Posted (Actual): August 28, 2019
• Last Update Submitted That Met QC Criteria: August 26, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Antineoplastic Agents, Immunological; Paclitaxel; Trastuzumab
• Other Study ID Numbers: OMC BC-04 (Other Identifier: Osaka Medical College)