Trial Outcomes & Findings for Safety and Efficacy of Trastuzumab BS (NCT NCT04181333)

Last Updated: 2026-04-14

Results Overview

An ADR was a treatment-related adverse event, and any untoward medical occurrence attributed to TRASTUZUMAB BS for Intravenous Infusion 60mg \[Pfizer\] and/or 150mg \[Pfizer\] in a participant who received this drug. A serious ADR was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; and congenital anomaly/birth defect. Relatedness to this drug was assessed.

Recruitment status

COMPLETED

Target enrollment

8 participants

Primary outcome timeframe

From Day 1 to 28 days after the last dose within 24 weeks; to the first dose after 24 weeks; or to the next treatment. If discontinued before 24 weeks, it was until 28 days after discontinuation or until the next treatment. Maximum duration was 28 weeks.

Results posted on

2026-04-14

Participant Flow

Participant milestones

Participant milestones
Measure	TRASTUZUMAB BS for Intravenous Infusion 60mg [Pfizer] and 150mg [Pfizer] (Trastuzumab Biosimilar 3) Participants who received TRASTUZUMAB BS for Intravenous Infusion 60mg \[Pfizer\] and/or 150mg \[Pfizer\], as indicated in the approved local product document, were observed for the period defined as follows: Given the first date of the administration as Day 1, the observation period was until 28 days after the date of the last dose within 24 weeks from Day 1; until the date of the first dose after 24 weeks from Day 1; or until the start of the next treatment, whichever came first. If the drug was discontinued before 24 weeks, the observation period was until 28 days after the date of discontinuation or until the start of the next treatment, whichever came first. The dosage can be adjusted as per physician's discretion.
Overall Study STARTED	8
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	TRASTUZUMAB BS for Intravenous Infusion 60mg [Pfizer] and 150mg [Pfizer] (Trastuzumab Biosimilar 3) Participants who received TRASTUZUMAB BS for Intravenous Infusion 60mg \[Pfizer\] and/or 150mg \[Pfizer\], as indicated in the approved local product document, were observed for the period defined as follows: Given the first date of the administration as Day 1, the observation period was until 28 days after the date of the last dose within 24 weeks from Day 1; until the date of the first dose after 24 weeks from Day 1; or until the start of the next treatment, whichever came first. If the drug was discontinued before 24 weeks, the observation period was until 28 days after the date of discontinuation or until the start of the next treatment, whichever came first. The dosage can be adjusted as per physician's discretion.
Overall Study No informed consent for publication of study results	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TRASTUZUMAB BS for Intravenous Infusion 60mg [Pfizer] and 150mg [Pfizer] (Trastuzumab Biosimilar 3) n=7 Participants Participants who received TRASTUZUMAB BS for Intravenous Infusion 60mg \[Pfizer\] and/or 150mg \[Pfizer\], as indicated in the approved local product document, were observed for the period defined as follows: Given the first date of the administration as Day 1, the observation period was until 28 days after the date of the last dose within 24 weeks from Day 1; until the date of the first dose after 24 weeks from Day 1; or until the start of the next treatment, whichever came first. If the drug was discontinued before 24 weeks, the observation period was until 28 days after the date of discontinuation or until the start of the next treatment, whichever came first. The dosage can be adjusted as per physician's discretion.
Age, Customized <15 years	0 Participants n=7 Participants
Age, Customized ≥15 and <65 years	0 Participants n=7 Participants
Age, Customized ≥65 years	7 Participants n=7 Participants
Sex: Female, Male Female	1 Participants n=7 Participants
Sex: Female, Male Male	6 Participants n=7 Participants

PRIMARY outcome

Timeframe: From Day 1 to 28 days after the last dose within 24 weeks; to the first dose after 24 weeks; or to the next treatment. If discontinued before 24 weeks, it was until 28 days after discontinuation or until the next treatment. Maximum duration was 28 weeks.

Population: The SAS comprised of participants who satisfied the inclusion criteria and had received TRASTUZUMAB BS for Intravenous Infusion 60mg \[Pfizer\] and/or 150mg \[Pfizer\]. Participants who did not provide informed consent was excluded.

Outcome measures

Outcome measures
Measure	TRASTUZUMAB BS for Intravenous Infusion 60mg [Pfizer] and 150mg [Pfizer] (Trastuzumab Biosimilar 3) n=7 Participants Participants who received TRASTUZUMAB BS for Intravenous Infusion 60mg \[Pfizer\] and/or 150mg \[Pfizer\], as indicated in the approved local product document, were observed for the period defined as follows: Given the first date of the administration as Day 1, the observation period was until 28 days after the date of the last dose within 24 weeks from Day 1; until the date of the first dose after 24 weeks from Day 1; or until the start of the next treatment, whichever came first. If the drug was discontinued before 24 weeks, the observation period was until 28 days after the date of discontinuation or until the start of the next treatment, whichever came first. The dosage can be adjusted as per physician's discretion.
The Incidence of Adverse Drug Reactions (ADRs) Serious ADR	0 Participants
The Incidence of Adverse Drug Reactions (ADRs) ADR	4 Participants

SECONDARY outcome

Timeframe: From Day 1 to 28 days after the last dose within 24 weeks from Day 1; to the first dose after 24 weeks; or to the next treatment. If discontinued, it ends at the time of discontinuation. Maximum duration was 28 weeks.

Population: The efficacy analysis set was defined as the population of participants in the SAS, excluding those who met any one of the following conditions: disease not under investigation or no effectiveness information. No participants were excluded from the SAS.

The physician in charge evaluated the effectiveness of this drug based on the best overall response \[complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), inevaluable (NE) or Non-CR/Non-PD\] using the effectiveness assessment items in the RECIST Version 1.1 at the end of the observation period or at discontinuation. The physician identified target lesions and non-target lesions in the classification of tumor lesions at the start of administration of this drug, and confirmed the presence or absence of new lesions in addition to the results of assessment of tumor response in each tumor lesion during the observation period, and then evaluated overall response. The total proportion of participants with CR + PR was evaluated as an overall response (OR) rate along with a 95% confidence interval.

Outcome measures

Outcome measures
Measure	TRASTUZUMAB BS for Intravenous Infusion 60mg [Pfizer] and 150mg [Pfizer] (Trastuzumab Biosimilar 3) n=7 Participants Participants who received TRASTUZUMAB BS for Intravenous Infusion 60mg \[Pfizer\] and/or 150mg \[Pfizer\], as indicated in the approved local product document, were observed for the period defined as follows: Given the first date of the administration as Day 1, the observation period was until 28 days after the date of the last dose within 24 weeks from Day 1; until the date of the first dose after 24 weeks from Day 1; or until the start of the next treatment, whichever came first. If the drug was discontinued before 24 weeks, the observation period was until 28 days after the date of discontinuation or until the start of the next treatment, whichever came first. The dosage can be adjusted as per physician's discretion.
Response Rate According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1	85.7 Percentage of Participants Interval 42.1 to 99.6

Adverse Events

TRASTUZUMAB BS for Intravenous Infusion 60mg [Pfizer] and 150mg [Pfizer] (Trastuzumab Biosimilar 3)

Serious events: 3 serious events

Other events: 6 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	TRASTUZUMAB BS for Intravenous Infusion 60mg [Pfizer] and 150mg [Pfizer] (Trastuzumab Biosimilar 3) n=7 participants at risk Participants who received TRASTUZUMAB BS for Intravenous Infusion 60mg \[Pfizer\] and/or 150mg \[Pfizer\], as indicated in the approved local product document, were observed for the period defined as follows: Given the first date of the administration as Day 1, the observation period was until 28 days after the date of the last dose within 24 weeks from Day 1; until the date of the first dose after 24 weeks from Day 1; or until the start of the next treatment, whichever came first. If the drug was discontinued before 24 weeks, the observation period was until 28 days after the date of discontinuation or until the start of the next treatment, whichever came first. The dosage can be adjusted as per physician's discretion.
Gastrointestinal disorders Mechanical ileus	14.3% 1/7 • From Day 1 to 28 days after the last dose within 24 weeks from Day 1; to the first dose after 24 weeks; or to the next treatment. If discontinued before 24 weeks, it was until 28 days after discontinuation or until the next treatment. Maximum duration was 28 weeks. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
General disorders Sudden death	14.3% 1/7 • From Day 1 to 28 days after the last dose within 24 weeks from Day 1; to the first dose after 24 weeks; or to the next treatment. If discontinued before 24 weeks, it was until 28 days after discontinuation or until the next treatment. Maximum duration was 28 weeks. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm malignant	14.3% 1/7 • From Day 1 to 28 days after the last dose within 24 weeks from Day 1; to the first dose after 24 weeks; or to the next treatment. If discontinued before 24 weeks, it was until 28 days after discontinuation or until the next treatment. Maximum duration was 28 weeks. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.

Other adverse events

Other adverse events
Measure	TRASTUZUMAB BS for Intravenous Infusion 60mg [Pfizer] and 150mg [Pfizer] (Trastuzumab Biosimilar 3) n=7 participants at risk Participants who received TRASTUZUMAB BS for Intravenous Infusion 60mg \[Pfizer\] and/or 150mg \[Pfizer\], as indicated in the approved local product document, were observed for the period defined as follows: Given the first date of the administration as Day 1, the observation period was until 28 days after the date of the last dose within 24 weeks from Day 1; until the date of the first dose after 24 weeks from Day 1; or until the start of the next treatment, whichever came first. If the drug was discontinued before 24 weeks, the observation period was until 28 days after the date of discontinuation or until the start of the next treatment, whichever came first. The dosage can be adjusted as per physician's discretion.
Blood and lymphatic system disorders Neutropenia	14.3% 1/7 • From Day 1 to 28 days after the last dose within 24 weeks from Day 1; to the first dose after 24 weeks; or to the next treatment. If discontinued before 24 weeks, it was until 28 days after discontinuation or until the next treatment. Maximum duration was 28 weeks. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Blood and lymphatic system disorders Thrombocytopenia	14.3% 1/7 • From Day 1 to 28 days after the last dose within 24 weeks from Day 1; to the first dose after 24 weeks; or to the next treatment. If discontinued before 24 weeks, it was until 28 days after discontinuation or until the next treatment. Maximum duration was 28 weeks. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
General disorders Chills	14.3% 1/7 • From Day 1 to 28 days after the last dose within 24 weeks from Day 1; to the first dose after 24 weeks; or to the next treatment. If discontinued before 24 weeks, it was until 28 days after discontinuation or until the next treatment. Maximum duration was 28 weeks. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
General disorders Pyrexia	14.3% 1/7 • From Day 1 to 28 days after the last dose within 24 weeks from Day 1; to the first dose after 24 weeks; or to the next treatment. If discontinued before 24 weeks, it was until 28 days after discontinuation or until the next treatment. Maximum duration was 28 weeks. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Injury, poisoning and procedural complications Infusion related reaction	14.3% 1/7 • From Day 1 to 28 days after the last dose within 24 weeks from Day 1; to the first dose after 24 weeks; or to the next treatment. If discontinued before 24 weeks, it was until 28 days after discontinuation or until the next treatment. Maximum duration was 28 weeks. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Renal and urinary disorders Renal impairment	14.3% 1/7 • From Day 1 to 28 days after the last dose within 24 weeks from Day 1; to the first dose after 24 weeks; or to the next treatment. If discontinued before 24 weeks, it was until 28 days after discontinuation or until the next treatment. Maximum duration was 28 weeks. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Respiratory, thoracic and mediastinal disorders Hypoxia	14.3% 1/7 • From Day 1 to 28 days after the last dose within 24 weeks from Day 1; to the first dose after 24 weeks; or to the next treatment. If discontinued before 24 weeks, it was until 28 days after discontinuation or until the next treatment. Maximum duration was 28 weeks. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Respiratory, thoracic and mediastinal disorders Pulmonary artery thrombosis	14.3% 1/7 • From Day 1 to 28 days after the last dose within 24 weeks from Day 1; to the first dose after 24 weeks; or to the next treatment. If discontinued before 24 weeks, it was until 28 days after discontinuation or until the next treatment. Maximum duration was 28 weeks. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Vascular disorders Hypertension	14.3% 1/7 • From Day 1 to 28 days after the last dose within 24 weeks from Day 1; to the first dose after 24 weeks; or to the next treatment. If discontinued before 24 weeks, it was until 28 days after discontinuation or until the next treatment. Maximum duration was 28 weeks. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER