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Neoadjuvant Ontruzant (SB3) in Patients With HER2-positive Early Breast Cancer: An Open-Label (NeoON)

NCT05036005 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2023-04-18

No results posted yet for this study

Summary

The treatment of patients with HER2 positive early breast cancer has continuously improved over the last decades. Up to now both, trastuzumab and pertuzumab are approved in combination with chemotherapy (CTX) not only for the adjuvant but also for the neoadjuvant treatment of early breast cancer patients. A high pCR rate in the neoadjuvant setting was shown in several trials and observational studies with CTX+ trastuzumab and with CTX+ pertuzumab. The efficacy is dependent on a variety of mechanisms including the blocking of the important PI3K/Akt and MAPK pathways, and ADCC (antibody dependent cellular toxicity).

Recently the biosimilar Ontruzant® (SB3) has been introduced into the treatment of HER2 positive breast cancer as a biosimilar. Efficacy and toxicity have been shown to be equivalent to the first approved antibody, however, data from the real-world setting have not been published like it has for the originally approved antibody. Therefore, the aim of this study is to establish safety and efficacy for Ontruzant® in the real world setting. Patients can be included if they are treated with Ontruzant® in the neoadjuvant setting. Additionally, the study will be accompanied by a comprehensive immune monitoring program and biomarker program to explore immune oncology potential for the neoadjuvant treatment.

Conditions

Interventions

DRUG

Ontruzant

All patients will receive an initial dose of Ontruzant® i.v. 8 mg/kg b.w in combination with standard chemotherapy with or without pertuzumab i.v. 480 mg followed by 5 cycles of Ontruzant® i.v. 6 mg/kg b.w. q21d in combination with standard chemotherapy with or without pertuzumab i.v. 420 mg. Addition of pertuzumab is at the discretion of investigator's decision.

DRUG

Chemotherapy

All patients will receive an initial dose of Ontruzant® i.v. 8 mg/kg b.w in combination with standard chemotherapy with or without pertuzumab i.v. 480 mg followed by 5 cycles of Ontruzant® i.v. 6 mg/kg b.w. q21d in combination with standard chemotherapy with or without pertuzumab i.v. 420 mg. Choice of chemotherapy is at the discretion of the investigator

DRUG

Pertuzumab

All patients will receive an initial dose of Ontruzant® i.v. 8 mg/kg b.w in combination with standard chemotherapy with or without pertuzumab i.v. 480 mg followed by 5 cycles of Ontruzant® i.v. 6 mg/kg b.w. q21d in combination with standard chemotherapy with or without pertuzumab i.v. 420 mg. Addition of pertuzumab is at the discretion of investigator's decision.

Sponsors & Collaborators

  • Samsung Bioepis Co., Ltd.

    collaborator INDUSTRY

  • Institut fuer Frauengesundheit

    lead OTHER

Principal Investigators

  • Diana Lüftner, MD, Prof. · Department for Hematology, Oncology and Tumor Immunology Charité Campus Benjamin Franklin, Berlin

  • Andreas Schneeweiss, MD, Prof. · National Center for Tumor Diseases (NCT), Head of Division Head of Division Gynecologic Oncology, Heidelberg University Hospital (UKHD)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-11
Primary Completion
2023-04-30
Completion
2023-07-31

Countries

  • Germany

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05036005 on ClinicalTrials.gov