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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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.

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

Condition or disease Intervention/treatment Phase
HER2 Positive Early or Locally Advanced Breast Cancer Drug: Herceptin (trastuzuamb) Drug: SB3 (proposed trastuzumab biosimilar) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 875 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : April 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Trastuzumab

Arm Intervention/treatment
Active Comparator: Herceptin (trastuzumab)
Intravenous administration
Drug: Herceptin (trastuzuamb)
Intravenous administration
Other Name: Herceptin

Experimental: SB3 (proposed trastuzumab biosimilar)
Intravenous administration
Drug: SB3 (proposed trastuzumab biosimilar)
Intravenous administration




Primary Outcome Measures :
  1. The Pathologic Complete Response (pCR) Rate of the Primary Breast Tumour [ Time Frame: Week 24 ]

Secondary Outcome Measures :
  1. Total Pathological Complete Response (tpCR) Rate [ Time Frame: Week 24 ]
  2. Overall Clinical Response Rate (ORR) [ Time Frame: Week 24 ]
  3. Event-free Survival (EFS) [ Time Frame: 1 month after last dose of investigational product ]
  4. Overall Survival (OS) [ Time Frame: 1 month after the last administration of investigational product ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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:

    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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02149524


Locations
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Czechia
Investigational Site
Praha, Czechia
Sponsors and Collaborators
Samsung Bioepis Co., Ltd.
Investigators
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Principal Investigator: Xavier Pivot CHU Besançon Hopital Jean Minjoz Service d'Oncologie Medicale

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Samsung Bioepis Co., Ltd.
ClinicalTrials.gov Identifier: NCT02149524     History of Changes
Other Study ID Numbers: SB3-G31-BC
2013-004172-35 ( EudraCT Number )
First Posted: May 29, 2014    Key Record Dates
Results First Posted: October 24, 2018
Last Update Posted: October 24, 2018
Last Verified: March 2018

Keywords provided by Samsung Bioepis Co., Ltd.:
HER2 Positive Breast Cancer
Trastuzumab
Biosimilar

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Trastuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents