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

Samsung Bioepis Co., Ltd.1 site in 1 country875 target enrollmentApril 2014

ConditionsHER2 Positive Early or Locally Advanced Breast Cancer

InterventionsHerceptin (trastuzuamb)SB3 (proposed trastuzumab biosimilar)

DrugsHerceptin (trastuzuamb)SB3 (proposed trastuzumab biosimilar)

Overview

Phase: Phase 3
Intervention: Herceptin (trastuzuamb)
Conditions: HER2 Positive Early or Locally Advanced Breast Cancer
Sponsor: Samsung Bioepis Co., Ltd.
Enrollment: 875
Locations: 1
Primary Endpoint: The Pathologic Complete Response (pCR) Rate of the Primary Breast Tumour
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

April 2014

End Date

February 2017

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Samsung Bioepis Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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:
•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

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:
•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)

Arms & Interventions

Herceptin (trastuzumab)

Intravenous administration

Intervention: Herceptin (trastuzuamb)

SB3 (proposed trastuzumab biosimilar)

Intravenous administration

Intervention: SB3 (proposed trastuzumab biosimilar)

Outcomes

Primary Outcomes

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

Time Frame: Week 24

Secondary Outcomes

Overall Clinical Response Rate (ORR)(Week 24)
Total Pathological Complete Response (tpCR) Rate(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)