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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02149524
• Date of registration: 26/05/2014
• Prospective Registration: No
• Primary sponsor: Samsung Bioepis Co., Ltd.
• Public title: A Study to Compare the Effect of SB3 and Herceptin® in Women With HER2 Positive Breast Cancer
• Scientific 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
• Date of first enrolment: April 2014
• Target sample size: 875
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02149524
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

Czech Republic, Czechia

Contacts

• Name: Xavier Pivot
• Affiliation: CHU Besançon Hopital Jean Minjoz Service d'Oncologie Medicale

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Female

Health Condition(s) or Problem(s) studied

HER2 Positive Early or Locally Advanced Breast Cancer

Intervention(s)

Drug: Herceptin (trastuzuamb)

Drug: SB3 (proposed trastuzumab biosimilar)

Primary Outcome(s)

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

Secondary Outcome(s)

Total Pathological Complete Response (tpCR) Rate [Time Frame: Week 24]

Event-free Survival (EFS) [Time Frame: 1 month after last dose of investigational product]

Overall Clinical Response Rate (ORR) [Time Frame: Week 24]

Overall Survival (OS) [Time Frame: 1 month after the last administration of investigational product]

Secondary ID(s)

SB3-G31-BC

2013-004172-35

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 24/10/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02149524