HER2 Positive Early or Locally Advanced Breast CancerPhase 3NCT02149524
A Study to Compare the Effect of SB3 and Herceptin® in Women With HER2 Positive Breast Cancer
A Phase 3 study testing Herceptin (trastuzuamb) and SB3 (proposed trastuzumab biosimilar) in people with HER2 Positive Early or Locally Advanced Breast Cancer, run by Samsung Bioepis Co., Ltd. at 1 site in Czechia.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- HER2 Positive Early or Locally Advanced Breast Cancer
- What is being tested?
- Herceptin (trastuzuamb) and SB3 (proposed trastuzumab biosimilar)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 875 participants
- Where
- 1 siteCzechia
- Study dates
- Apr 2014to Feb 2017
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)+
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- 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
Who cannot join
- 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)
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- 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
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Herceptin (trastuzuamb), SB3 (proposed trastuzumab biosimilar)
- Keywords
- HER2 Positive Breast Cancer, Trastuzumab, Biosimilar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Herceptin (trastuzuamb)Drug
Also called Herceptin
Intravenous administration
SB3 (proposed trastuzumab biosimilar)Drug
Intravenous administration
| Study group | Role | What they receive |
|---|---|---|
| Herceptin (trastuzumab) | Active comparator | Intravenous administration Receives: Drug: Herceptin (trastuzuamb) |
| SB3 (proposed trastuzumab biosimilar) | Experimental | Intravenous administration Receives: Drug: SB3 (proposed trastuzumab biosimilar) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Pathologic Complete Response (pCR) Rate of the Primary Breast Tumour
Measured: Week 24
Secondary outcomes (4)
Total Pathological Complete Response (tpCR) Rate
Measured: Week 24
Overall Clinical Response Rate (ORR)
Measured: Week 24
Event-free Survival (EFS)
Measured: 1 month after last dose of investigational product
Overall Survival (OS)
Measured: 1 month after the last administration of investigational product
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2014 (estimated)
- Study startApr 2014
- Primary completionMar 2016
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HER2 Positive Early or Locally Advanced Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 875 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Bioepis Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xavier Pivot, Principal investigator, CHU Besançon Hopital Jean Minjoz Service d'Oncologie Medicale
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02149524
- Sponsor's protocol ID
- SB3-G31-BC
- Other IDs
- 2013-004172-35
- Status last verified
- Mar 2018
- First submitted
- 26 May 2014
- Last updated
- 24 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 29448072Pivot 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.
PubMed 29373094
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02149524
- Acronym / sponsor ID
- SB3-G31-BC
- Keywords
- HER2 Positive Breast Cancer, Trastuzumab, Biosimilar
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 875 participants (actual)
- Lead sponsor
- Samsung Bioepis Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2014 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 29 May 2014 (estimated)
- Results
- Posted 24 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Herceptin (trastuzumab) | Active comparator | Drug: Herceptin (trastuzuamb)Intravenous administration |
| SB3 (proposed trastuzumab biosimilar) | Experimental | Drug: SB3 (proposed trastuzumab biosimilar)Intravenous administration |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- 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
Key exclusion criteria (22 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Herceptin (trastuzuamb)Also: HerceptinIntravenous administration | Drug | Herceptin (trastuzumab) |
| SB3 (proposed trastuzumab biosimilar)Intravenous administration | Drug | SB3 (proposed trastuzumab biosimilar) |
Primary outcome
The Pathologic Complete Response (pCR) Rate of the Primary Breast Tumour
Time frame: Week 24
4 secondary outcomes
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29448072Pivot 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.
- Derived from this study: PubMed 29373094Pivot 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xavier Pivot principal investigator
CHU Besançon Hopital Jean Minjoz Service d'Oncologie Medicale
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Herceptin (trastuzuamb) and SB3 (proposed trastuzumab biosimilar) in people with HER2 Positive Early or Locally Advanced Breast Cancer, run by Samsung Bioepis Co., Ltd. at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Pathologic Complete Response (pCR) Rate of the Primary Breast Tumour (time frame: Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02149524, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2018.