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

NCT02149524 | Completed Phase 3 Results DMC

• 2 other identifiers: SB3-G31-BC2013-004172-35
• Study Type: interventional
• Target: 875
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

HER2 Positive Early or Locally Advanced Breast Cancer

Keywords

HER2 Positive Breast Cancer; Trastuzumab; Biosimilar

Outcome Measures

Primary Outcomes (1)

• The Pathologic Complete Response (pCR) Rate of the Primary Breast Tumour

  Week 24

Secondary Outcomes (4)

• Total Pathological Complete Response (tpCR) Rate

  Week 24

• Overall Clinical Response Rate (ORR)

  Week 24

• Event-free Survival (EFS)

  1 month after last dose of investigational product

• Overall Survival (OS)

  1 month after the last administration of investigational product

Study Arms (2)

Herceptin (trastuzumab)

ACTIVE COMPARATOR

Intravenous administration

Drug: Herceptin (trastuzuamb)

SB3 (proposed trastuzumab biosimilar)

EXPERIMENTAL

Intravenous administration

Drug: SB3 (proposed trastuzumab biosimilar)

Interventions

Herceptin (trastuzuamb) DRUG

Intravenous administration

Also known as: Herceptin

Herceptin (trastuzumab)

SB3 (proposed trastuzumab biosimilar) DRUG

Intravenous administration

SB3 (proposed trastuzumab biosimilar)

Eligibility Criteria

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

You may qualify if:

• 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:
• tumour size ≥ 2 cm
• histologically confirmed primary invasive carcinoma of the breast
• 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

You may not qualify if:

• 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:
• history of documented congestive heart failure (CHF) (New York Heart Association, NYHA, class II or greater heart disease)
• LVEF \< 55% by echocardiography or MUGA scan
• angina pectoris requiring anti-anginal medication
• evidence of transmural infarction on electrocardiogram (ECG)
• uncontrolled hypertension (systolic \> 180 mmHg and/or diastolic \> 100 mmHg)
• clinically significant valvular heart disease
• 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

Sponsors & Collaborators

• Samsung Bioepis Co., Ltd.: lead

Study Sites (1)

Investigational Site

Prague, Czechia

Location

Related Publications (2)

• Pivot X, Bondarenko I, Nowecki Z, Dvorkin M, Trishkina E, Ahn JH, Im SA, Sarosiek T, Chatterjee S, Wojtukiewicz MZ, Shparyk Y, Moiseyenko V, Bello M 3rd, Semiglazov V, Lee Y, Lim J. A phase III study comparing SB3 (a proposed trastuzumab biosimilar) and trastuzumab reference product in HER2-positive early breast cancer treated with neoadjuvant-adjuvant treatment: Final safety, immunogenicity and survival results. Eur J Cancer. 2018 Apr;93:19-27. doi: 10.1016/j.ejca.2018.01.072. Epub 2018 Feb 12.

  PMID: 29448072 DERIVED

• Pivot X, Bondarenko I, Nowecki Z, Dvorkin M, Trishkina E, Ahn JH, Vinnyk Y, Im SA, Sarosiek T, Chatterjee S, Wojtukiewicz MZ, Moiseyenko V, Shparyk Y, Bello M 3rd, Semiglazov V, Song S, Lim J. Phase III, Randomized, Double-Blind Study Comparing the Efficacy, Safety, and Immunogenicity of SB3 (Trastuzumab Biosimilar) and Reference Trastuzumab in Patients Treated With Neoadjuvant Therapy for Human Epidermal Growth Factor Receptor 2-Positive Early Breast Cancer. J Clin Oncol. 2018 Apr 1;36(10):968-974. doi: 10.1200/JCO.2017.74.0126. Epub 2018 Jan 26.

  PMID: 29373094 DERIVED

MeSH Terms

Interventions

Trastuzumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Samsung Bioepis Co., Ltd.

sbregistry@samsung.com

Study Officials

• Xavier Pivot

  CHU Besançon Hopital Jean Minjoz Service d'Oncologie Medicale

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2014
• First Posted: May 29, 2014
• Study Start: April 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: February 1, 2017
• Last Updated: October 24, 2018
• Results First Posted: October 24, 2018

Record last verified: 2018-03

Locations

CZ (1)