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

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ClinicalTrials.gov Identifier: NCT02149524
Recruitment Status : Completed
First Posted : May 29, 2014
Results First Posted : October 24, 2018
Last Update Posted : October 24, 2018
Sponsor:
Information provided by (Responsible Party):
Samsung Bioepis Co., Ltd.

Tracking Information
First Submitted Date  ICMJE May 26, 2014
First Posted Date  ICMJE May 29, 2014
Results First Submitted Date  ICMJE March 14, 2018
Results First Posted Date  ICMJE October 24, 2018
Last Update Posted Date October 24, 2018
Actual Study Start Date  ICMJE April 2014
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 14, 2018)
The Pathologic Complete Response (pCR) Rate of the Primary Breast Tumour [ Time Frame: Week 24 ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 26, 2014)
The pathologic complete response (pCR) rate of the primary breast tumour [ Time Frame: Week 24 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 14, 2018)
  • Total Pathological Complete Response (tpCR) Rate [ Time Frame: Week 24 ]
  • Overall Clinical Response Rate (ORR) [ Time Frame: Week 24 ]
  • Event-free Survival (EFS) [ Time Frame: 1 month after last dose of investigational product ]
  • Overall Survival (OS) [ Time Frame: 1 month after the last administration of investigational product ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 26, 2014)
  • total pathological complete response (tpCR) rate [ Time Frame: Week 24 ]
  • Overall clinical response rate (ORR) [ Time Frame: Week 24 ]
  • Event-free survival (EFS) [ Time Frame: 1 month after last dose of investigational product ]
  • Overall survival (OS) [ Time Frame: 1 month after the last administration of investigational product ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Compare the Effect of SB3 and Herceptin® in Women With HER2 Positive Breast Cancer
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE HER2 Positive Early or Locally Advanced Breast Cancer
Intervention  ICMJE
  • Drug: Herceptin (trastuzuamb)
    Intravenous administration
    Other Name: Herceptin
  • Drug: SB3 (proposed trastuzumab biosimilar)
    Intravenous administration
Study Arms  ICMJE
  • Active Comparator: Herceptin (trastuzumab)
    Intravenous administration
    Intervention: Drug: Herceptin (trastuzuamb)
  • Experimental: SB3 (proposed trastuzumab biosimilar)
    Intravenous administration
    Intervention: Drug: SB3 (proposed trastuzumab biosimilar)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 22, 2018)
875
Original Estimated Enrollment  ICMJE
 (submitted: May 26, 2014)
498
Actual Study Completion Date  ICMJE February 2017
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Czechia
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT02149524
Other Study ID Numbers  ICMJE SB3-G31-BC
2013-004172-35 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Samsung Bioepis Co., Ltd.
Study Sponsor  ICMJE Samsung Bioepis Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Xavier Pivot CHU Besançon Hopital Jean Minjoz Service d'Oncologie Medicale
PRS Account Samsung Bioepis Co., Ltd.
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP