A Study to Compare the Effect of SB3 and Herceptin® in Women With HER2 Positive Breast Cancer

March 14, 2018 updated by: Samsung Bioepis Co., Ltd.

A Phase III Randomised, Double-Blind, Parallel Group, Multicentre Study to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenicity Between SB3 (Proposed Trastuzumab Biosimilar) and Herceptin® in Women With Newly Diagnosed HER2 Positive Early or Locally Advanced Breast Cancer in Neoadjuvant Setting

A Phase III Randomised, Double-Blind, Parallel Group, Multicentre Study to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenicity between SB3 (proposed trastuzumab biosimilar) and Herceptin® in Women with Newly Diagnosed HER2 Positive Early or Locally Advanced Breast Cancer in Neoadjuvant Setting

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

875

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Praha, Czechia
        • Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female aged 18-65 years
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

  • Non-metastatic, unilateral newly diagnosed primary breast cancer of clinical stage II to III including inflammatory breast cancer with:

    1. tumour size ≥ 2 cm
    2. histologically confirmed primary invasive carcinoma of the breast
    3. HER2-positivity confirmed by a central laboratory or an accredited local laboratory and defined as immunohistochemistry (IHC) 3+ or fluorescence in situ hybridisation (FISH)+
  • Known hormone receptor (oestrogen receptor and progesterone receptor) status
  • Baseline left ventricular ejection fraction (LVEF) ≥ 55% measured by echocardiography or multiple gated acquisition (MUGA) scan
  • Subjects must be able to provide informed consent, which must be obtained prior to any study related procedures

Exclusion Criteria:

  • Metastatic (stage IV) or bilateral or multifocal/multicentric breast cancer
  • History of any prior invasive breast carcinoma, except for subjects with a past history of ductal carcinoma in situ (DCIS) and/or lobular carcinoma in situ (LCIS) treated with surgery only
  • Past or current history of malignant neoplasms within 5 years prior to Randomisation, except for curatively treated carcinoma in situ of uterine cervix, basal cell carcinoma of the skin or squamous cell carcinoma of the skin (malignant neoplasms occurring more than 5 years prior to Randomisation are permitted if curatively treated with surgery only)
  • Previous history of radiation therapy, immunotherapy, chemotherapy or biotherapy (including prior HER2 directed therapy) Major surgery within 4 weeks prior to Randomisation and minor surgery within 2 weeks prior to Randomisation (major surgery is defined as surgery which requires general anaesthesia)

  • Serious cardiac illness that would preclude the use of trastuzumab such as:

    1. history of documented congestive heart failure (CHF) (New York Heart Association, NYHA, class II or greater heart disease)
    2. LVEF < 55% by echocardiography or MUGA scan
    3. angina pectoris requiring anti-anginal medication
    4. evidence of transmural infarction on electrocardiogram (ECG)
    5. uncontrolled hypertension (systolic > 180 mmHg and/or diastolic > 100 mmHg)
    6. clinically significant valvular heart disease
    7. high risk uncontrolled arrhythmias
  • Serious pulmonary illness enough to cause dyspnoea at rest or requiring supplementary oxygen therapy
  • Known history of hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV) infection
  • Other concurrent serious illnesses that may interfere with planned therapy including severe cardiovascular, pulmonary, metabolic or infectious conditions
  • Known hypersensitivity to the investigational product (IPs), non-IPs or any of the ingredients or excipients of the IPs or non-IPs
  • Known hypersensitivity to murine proteins
  • Known history of dihydropyrimidine dehydrogenase (DPD) deficiency
  • Pre-existing peripheral sensory or motor neuropathy ≥ grade 2, defined by National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.0
  • Pregnant or lactating women. A pregnancy test result is required for all women of childbearing potential including women who had menopause onset within 2 years prior to Randomisation. Women of childbearing potential must agree to use contraceptive methods (see section 7.4.2) during the study and 6 months after the last dose of IP
  • Concurrent hormonal therapy including birth control pills, ovarian hormone replacement for menopause, selective oestrogen receptor modulator (SERM) either for osteoporosis or breast cancer prevention
  • Subjects unwilling to follow the study requirements

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Herceptin (trastuzumab)
Intravenous administration
Drug: Herceptin (trastuzuamb)
Intravenous administration
Other Names:
  • Herceptin
EXPERIMENTAL: SB3 (proposed trastuzumab biosimilar)
Intravenous administration
Drug: SB3 (proposed trastuzumab biosimilar)
Intravenous administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The Pathologic Complete Response (pCR) Rate of the Primary Breast Tumour
Time Frame: Week 24
Week 24

Secondary Outcome Measures

Outcome Measure
Time Frame
Total Pathological Complete Response (tpCR) Rate
Time Frame: Week 24
Week 24
Overall Clinical Response Rate (ORR)
Time Frame: Week 24
Week 24
Event-free Survival (EFS)
Time Frame: 1 month after last dose of investigational product
1 month after last dose of investigational product
Overall Survival (OS)
Time Frame: 1 month after the last administration of investigational product
1 month after the last administration of investigational product

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Bioepis Co., Ltd.

Investigators

  • Principal Investigator: Xavier Pivot, CHU Besançon Hopital Jean Minjoz Service d'Oncologie Medicale

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2014

Primary Completion (ACTUAL)

March 1, 2016

Study Completion (ACTUAL)

February 1, 2017

Study Registration Dates

First Submitted

May 26, 2014

First Submitted That Met QC Criteria

May 26, 2014

First Posted (ESTIMATE)

May 29, 2014

Study Record Updates

Last Update Posted (ACTUAL)

October 24, 2018

Last Update Submitted That Met QC Criteria

March 14, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SB3-G31-BC
  • 2013-004172-35 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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