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

NCT02598310 | Terminated Phase 2 DMC

• 1 other identifier: OMC BC-04
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Pathological complete response rate

  Up to 12 weeks after the protocol therapy

Secondary Outcomes (5)

• 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

Study Arms (1)

nab-paclitaxel plus trastuzumab

EXPERIMENTAL

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; Drug: Trastuzumab

Interventions

nab-paclitaxel DRUG

nab-paclitaxel 260mg/m2 q3w

Also known as: Abraxane

nab-paclitaxel plus trastuzumab

Trastuzumab DRUG

trastuzumab 6 mg/kg (8 mg/kg as the loading dose)

Also known as: Herceptin

nab-paclitaxel plus trastuzumab

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Osaka Medical College: lead

Study Sites (1)

Osaka Medical College

Takatsuki, Osaka, 5698686, Japan

Location

Related Publications (1)

• 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.

  PMID: 30963212 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

130-nm albumin-bound paclitaxel; Albumin-Bound Paclitaxel; Trastuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins

Study Officials

• Mitsuhiko Iwamoto, MD, PhD

  Osaka Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: November 2, 2015
• First Posted: November 5, 2015
• Study Start: November 1, 2015
• Primary Completion: November 30, 2018
• Study Completion: November 30, 2018
• Last Updated: August 28, 2019

Record last verified: 2019-08

Locations

JP (1)