Trial Outcomes & Findings for A Study to Compare the Effect of SB3 and Herceptin® in Women With HER2 Positive Breast Cancer (NCT NCT02149524)
NCT ID: NCT02149524
Last Updated: 2018-10-24
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
875 participants
Primary outcome timeframe
Week 24
Results posted on
2018-10-24
Participant Flow
Participant milestones
| Measure |
Herceptin (Trastuzumab)
Intravenous administration
Herceptin (trastuzuamb): Intravenous administration
|
SB3 (Proposed Trastuzumab Biosimilar)
Intravenous administration
SB3 (proposed trastuzumab biosimilar): Intravenous administration
|
|---|---|---|
|
Overall Study
STARTED
|
438
|
437
|
|
Overall Study
COMPLETED
|
384
|
380
|
|
Overall Study
NOT COMPLETED
|
54
|
57
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Age data for one subject is missing.
Baseline characteristics by cohort
| Measure |
Herceptin (Trastuzumab)
n=438 Participants
Intravenous administration
Herceptin (trastuzuamb): Intravenous administration
|
SB3 (Proposed Trastuzumab Biosimilar)
n=437 Participants
Intravenous administration
SB3 (proposed trastuzumab biosimilar): Intravenous administration
|
Total
n=875 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.6 years
STANDARD_DEVIATION 9.38 • n=437 Participants • Age data for one subject is missing.
|
49.5 years
STANDARD_DEVIATION 9.51 • n=437 Participants • Age data for one subject is missing.
|
49.6 years
STANDARD_DEVIATION 9.44 • n=874 Participants • Age data for one subject is missing.
|
|
Sex: Female, Male
Female
|
438 Participants
n=438 Participants
|
437 Participants
n=437 Participants
|
875 Participants
n=875 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=438 Participants
|
0 Participants
n=437 Participants
|
0 Participants
n=875 Participants
|
PRIMARY outcome
Timeframe: Week 24Population: Per-protocol set
Outcome measures
| Measure |
Herceptin (Trastuzumab)
n=398 Participants
Intravenous administration
Herceptin (trastuzuamb): Intravenous administration
|
SB3 (Proposed Trastuzumab Biosimilar)
n=402 Participants
Intravenous administration
SB3 (proposed trastuzumab biosimilar): Intravenous administration
|
|---|---|---|
|
The Pathologic Complete Response (pCR) Rate of the Primary Breast Tumour
|
42.0 percentage of responders
|
51.7 percentage of responders
|
SECONDARY outcome
Timeframe: Week 24Population: Per-protocol set
Outcome measures
| Measure |
Herceptin (Trastuzumab)
n=380 Participants
Intravenous administration
Herceptin (trastuzuamb): Intravenous administration
|
SB3 (Proposed Trastuzumab Biosimilar)
n=382 Participants
Intravenous administration
SB3 (proposed trastuzumab biosimilar): Intravenous administration
|
|---|---|---|
|
Total Pathological Complete Response (tpCR) Rate
|
35.8 percentage of responders
|
45.8 percentage of responders
|
SECONDARY outcome
Timeframe: Week 24Population: Per-protocol set
Outcome measures
| Measure |
Herceptin (Trastuzumab)
n=374 Participants
Intravenous administration
Herceptin (trastuzuamb): Intravenous administration
|
SB3 (Proposed Trastuzumab Biosimilar)
n=383 Participants
Intravenous administration
SB3 (proposed trastuzumab biosimilar): Intravenous administration
|
|---|---|---|
|
Overall Clinical Response Rate (ORR)
|
91.2 percentage of responders
|
96.3 percentage of responders
|
SECONDARY outcome
Timeframe: 1 month after last dose of investigational productPopulation: Per-protocol set
Outcome measures
| Measure |
Herceptin (Trastuzumab)
n=398 Participants
Intravenous administration
Herceptin (trastuzuamb): Intravenous administration
|
SB3 (Proposed Trastuzumab Biosimilar)
n=402 Participants
Intravenous administration
SB3 (proposed trastuzumab biosimilar): Intravenous administration
|
|---|---|---|
|
Event-free Survival (EFS)
|
92.7 percentage of subjects without event
|
93.8 percentage of subjects without event
|
SECONDARY outcome
Timeframe: 1 month after the last administration of investigational productPopulation: Per-protocol set
Outcome measures
| Measure |
Herceptin (Trastuzumab)
n=398 Participants
Intravenous administration
Herceptin (trastuzuamb): Intravenous administration
|
SB3 (Proposed Trastuzumab Biosimilar)
n=402 Participants
Intravenous administration
SB3 (proposed trastuzumab biosimilar): Intravenous administration
|
|---|---|---|
|
Overall Survival (OS)
|
99.5 percentage of subjects alive
|
100.0 percentage of subjects alive
|
Adverse Events
Herceptin (Trastuzumab)
Serious events: 58 serious events
Other events: 420 other events
Deaths: 5 deaths
SB3 (Proposed Trastuzumab Biosimilar)
Serious events: 56 serious events
Other events: 426 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Herceptin (Trastuzumab)
n=438 participants at risk
Intravenous administration
Herceptin (trastuzuamb): Intravenous administration
|
SB3 (Proposed Trastuzumab Biosimilar)
n=437 participants at risk
Intravenous administration
SB3 (proposed trastuzumab biosimilar): Intravenous administration
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.0%
13/438 • Number of events 14
|
2.3%
10/437 • Number of events 11
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.1%
5/438 • Number of events 5
|
1.6%
7/437 • Number of events 7
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/438
|
0.46%
2/437 • Number of events 3
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/438
|
0.23%
1/437 • Number of events 3
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.23%
1/438 • Number of events 1
|
0.00%
0/437
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.23%
1/438 • Number of events 1
|
0.00%
0/437
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/438
|
0.69%
3/437 • Number of events 3
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/438
|
0.23%
1/437 • Number of events 1
|
|
Cardiac disorders
Myocardial infarction
|
0.23%
1/438 • Number of events 1
|
0.00%
0/437
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/438
|
0.23%
1/437 • Number of events 1
|
|
Eye disorders
Retinal haemorrhage
|
0.23%
1/438 • Number of events 1
|
0.00%
0/437
|
|
Gastrointestinal disorders
Diarrhoea
|
0.68%
3/438 • Number of events 3
|
0.69%
3/437 • Number of events 5
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/438
|
0.46%
2/437 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/438
|
0.23%
1/437 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/438
|
0.23%
1/437 • Number of events 1
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/438
|
0.23%
1/437 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
0.46%
2/438 • Number of events 2
|
0.23%
1/437 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis
|
0.23%
1/438 • Number of events 1
|
0.00%
0/437
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.23%
1/438 • Number of events 1
|
0.00%
0/437
|
|
General disorders
Asthenia
|
0.00%
0/438
|
0.23%
1/437 • Number of events 1
|
|
General disorders
Extravasation
|
0.00%
0/438
|
0.23%
1/437 • Number of events 1
|
|
General disorders
Medical device complication
|
0.00%
0/438
|
0.23%
1/437 • Number of events 1
|
|
General disorders
Pyrexia
|
0.46%
2/438 • Number of events 2
|
0.23%
1/437 • Number of events 1
|
|
General disorders
Fatigue
|
0.23%
1/438 • Number of events 1
|
0.00%
0/437
|
|
General disorders
Sudden death
|
0.23%
1/438 • Number of events 1
|
0.00%
0/437
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/438
|
0.23%
1/437 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
0.00%
0/438
|
0.92%
4/437 • Number of events 5
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/438
|
0.46%
2/437 • Number of events 2
|
|
Infections and infestations
Bronchitis
|
0.00%
0/438
|
0.23%
1/437 • Number of events 1
|
|
Infections and infestations
Cellulitis
|
0.23%
1/438 • Number of events 1
|
0.23%
1/437 • Number of events 1
|
|
Infections and infestations
Furuncle
|
0.00%
0/438
|
0.23%
1/437 • Number of events 1
|
|
Infections and infestations
Gastroenteritis
|
0.23%
1/438 • Number of events 1
|
0.23%
1/437 • Number of events 1
|
|
Infections and infestations
Neutropenic sepsis
|
0.23%
1/438 • Number of events 1
|
0.23%
1/437 • Number of events 1
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/438
|
0.23%
1/437 • Number of events 1
|
|
Infections and infestations
Tuberculosis
|
0.00%
0/438
|
0.23%
1/437 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/438
|
0.23%
1/437 • Number of events 1
|
|
Infections and infestations
Bronchopneumonia
|
0.23%
1/438 • Number of events 1
|
0.00%
0/437
|
|
Infections and infestations
Dengue fever
|
0.46%
2/438 • Number of events 2
|
0.00%
0/437
|
|
Infections and infestations
Erysipelas
|
0.23%
1/438 • Number of events 1
|
0.00%
0/437
|
|
Infections and infestations
Influenza
|
0.46%
2/438 • Number of events 2
|
0.00%
0/437
|
|
Infections and infestations
Intraspinal abscess
|
0.23%
1/438 • Number of events 1
|
0.00%
0/437
|
|
Infections and infestations
Lobar pneumonia
|
0.23%
1/438 • Number of events 1
|
0.00%
0/437
|
|
Infections and infestations
Neutropenic infection
|
0.23%
1/438 • Number of events 1
|
0.00%
0/437
|
|
Infections and infestations
Postoperative wound infection
|
0.23%
1/438 • Number of events 1
|
0.00%
0/437
|
|
Infections and infestations
Wound infection
|
0.23%
1/438 • Number of events 2
|
0.00%
0/437
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/438
|
0.23%
1/437 • Number of events 1
|
|
Injury, poisoning and procedural complications
Radiation necrosis
|
0.00%
0/438
|
0.23%
1/437 • Number of events 1
|
|
Injury, poisoning and procedural complications
Radiation pneumonitis
|
0.00%
0/438
|
0.23%
1/437 • Number of events 1
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.23%
1/438 • Number of events 1
|
0.00%
0/437
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.46%
2/438 • Number of events 2
|
0.00%
0/437
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.23%
1/438 • Number of events 1
|
0.00%
0/437
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.46%
2/438 • Number of events 2
|
0.00%
0/437
|
|
Injury, poisoning and procedural complications
Radiation mucositis
|
0.23%
1/438 • Number of events 1
|
0.00%
0/437
|
|
Investigations
Neutrophil count decreased
|
0.91%
4/438 • Number of events 7
|
1.8%
8/437 • Number of events 20
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.23%
1/438 • Number of events 1
|
0.23%
1/437 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.23%
1/438 • Number of events 1
|
0.23%
1/437 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.23%
1/438 • Number of events 1
|
0.23%
1/437 • Number of events 1
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.23%
1/438 • Number of events 1
|
0.00%
0/437
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/438
|
0.46%
2/437 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.23%
1/438 • Number of events 1
|
0.00%
0/437
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/438
|
0.23%
1/437 • Number of events 1
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.23%
1/438 • Number of events 1
|
0.00%
0/437
|
|
Nervous system disorders
Convulsion
|
0.46%
2/438 • Number of events 2
|
0.00%
0/437
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.23%
1/438 • Number of events 1
|
0.00%
0/437
|
|
Nervous system disorders
Ischaemic stroke
|
0.23%
1/438 • Number of events 1
|
0.00%
0/437
|
|
Nervous system disorders
Transient ischaemic attack
|
0.23%
1/438 • Number of events 1
|
0.00%
0/437
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/438
|
0.23%
1/437 • Number of events 1
|
|
Psychiatric disorders
Hallucination, auditory
|
0.00%
0/438
|
0.23%
1/437 • Number of events 1
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/438
|
0.23%
1/437 • Number of events 1
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/438
|
0.23%
1/437 • Number of events 1
|
|
Reproductive system and breast disorders
Ovarian hyperstimulation syndrome
|
0.00%
0/438
|
0.23%
1/437 • Number of events 1
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.23%
1/438 • Number of events 1
|
0.00%
0/437
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/438
|
0.23%
1/437 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.00%
0/438
|
0.23%
1/437 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.46%
2/438 • Number of events 2
|
0.23%
1/437 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.23%
1/438 • Number of events 1
|
0.00%
0/437
|
|
Vascular disorders
Hypertension
|
0.00%
0/438
|
0.23%
1/437 • Number of events 1
|
|
Vascular disorders
Hypotension
|
0.23%
1/438 • Number of events 1
|
0.00%
0/437
|
Other adverse events
| Measure |
Herceptin (Trastuzumab)
n=438 participants at risk
Intravenous administration
Herceptin (trastuzuamb): Intravenous administration
|
SB3 (Proposed Trastuzumab Biosimilar)
n=437 participants at risk
Intravenous administration
SB3 (proposed trastuzumab biosimilar): Intravenous administration
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
63.9%
280/438 • Number of events 634
|
67.0%
293/437 • Number of events 654
|
|
Blood and lymphatic system disorders
Leukopenia
|
25.8%
113/438 • Number of events 237
|
28.6%
125/437 • Number of events 259
|
|
Blood and lymphatic system disorders
Anaemia
|
21.7%
95/438 • Number of events 198
|
22.0%
96/437 • Number of events 180
|
|
Gastrointestinal disorders
Nausea
|
30.8%
135/438 • Number of events 388
|
32.7%
143/437 • Number of events 362
|
|
Gastrointestinal disorders
Diarrhoea
|
14.8%
65/438 • Number of events 90
|
20.8%
91/437 • Number of events 143
|
|
Gastrointestinal disorders
Vomiting
|
11.4%
50/438 • Number of events 87
|
14.0%
61/437 • Number of events 110
|
|
Gastrointestinal disorders
Stomatitis
|
11.6%
51/438 • Number of events 88
|
14.0%
61/437 • Number of events 107
|
|
Gastrointestinal disorders
Dyspepsia
|
5.0%
22/438 • Number of events 27
|
5.9%
26/437 • Number of events 39
|
|
General disorders
Fatigue
|
18.0%
79/438 • Number of events 182
|
20.1%
88/437 • Number of events 186
|
|
General disorders
Asthenia
|
12.6%
55/438 • Number of events 162
|
13.0%
57/437 • Number of events 145
|
|
General disorders
Pyrexia
|
8.4%
37/438 • Number of events 48
|
8.9%
39/437 • Number of events 50
|
|
General disorders
Oedema peripheral
|
7.1%
31/438 • Number of events 34
|
4.1%
18/437 • Number of events 27
|
|
Infections and infestations
Upper respiratory tract infection
|
9.1%
40/438 • Number of events 64
|
10.1%
44/437 • Number of events 66
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
8.7%
38/438 • Number of events 47
|
11.0%
48/437 • Number of events 48
|
|
Injury, poisoning and procedural complications
Procedural pain
|
12.1%
53/438 • Number of events 54
|
8.9%
39/437 • Number of events 41
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
9.6%
42/438 • Number of events 62
|
8.5%
37/437 • Number of events 53
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
4.8%
21/438 • Number of events 21
|
6.2%
27/437 • Number of events 27
|
|
Investigations
Alanine aminotransferase increased
|
18.9%
83/438 • Number of events 150
|
19.2%
84/437 • Number of events 150
|
|
Investigations
Aspartate aminotransferase increased
|
14.4%
63/438 • Number of events 110
|
15.6%
68/437 • Number of events 102
|
|
Investigations
Neutrophil count decreased
|
12.1%
53/438 • Number of events 162
|
12.1%
53/437 • Number of events 124
|
|
Investigations
White blood cell count decreased
|
7.3%
32/438 • Number of events 71
|
5.7%
25/437 • Number of events 69
|
|
Investigations
Blood alkaline phosphatase increased
|
6.6%
29/438 • Number of events 43
|
5.0%
22/437 • Number of events 40
|
|
Metabolism and nutrition disorders
Decreased appetite
|
9.4%
41/438 • Number of events 103
|
9.2%
40/437 • Number of events 78
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
15.1%
66/438 • Number of events 138
|
14.4%
63/437 • Number of events 148
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.7%
47/438 • Number of events 70
|
11.0%
48/437 • Number of events 74
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
4.6%
20/438 • Number of events 21
|
6.2%
27/437 • Number of events 33
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.5%
24/438 • Number of events 39
|
5.3%
23/437 • Number of events 39
|
|
Nervous system disorders
Headache
|
7.3%
32/438 • Number of events 51
|
7.1%
31/437 • Number of events 55
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.3%
23/438 • Number of events 40
|
6.9%
30/437 • Number of events 42
|
|
Nervous system disorders
Neuropathy peripheral
|
2.7%
12/438 • Number of events 12
|
5.0%
22/437 • Number of events 24
|
|
Psychiatric disorders
Insomnia
|
5.0%
22/438 • Number of events 31
|
5.0%
22/437 • Number of events 32
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.2%
27/438 • Number of events 34
|
9.4%
41/437 • Number of events 46
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
4.3%
19/438 • Number of events 22
|
5.7%
25/437 • Number of events 28
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
64.6%
283/438 • Number of events 324
|
68.4%
299/437 • Number of events 349
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.3%
45/438 • Number of events 62
|
10.8%
47/437 • Number of events 61
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
5.3%
23/438 • Number of events 23
|
5.0%
22/437 • Number of events 23
|
|
Vascular disorders
Lymphorrhoea
|
6.8%
30/438 • Number of events 51
|
7.3%
32/437 • Number of events 58
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee At least sixty (60) days prior to submitting or presenting a manuscript or other materials relating to the Study to a publisher, reviewer, or other outside persons, the Site shall provide to Sponsor a copy of all such manuscripts and materials, and allow Sponsor sixty (60) days to review and comment on them.
- Publication restrictions are in place
Restriction type: OTHER