Trial Outcomes & Findings for Efficacy and Safety of Trastuzumab Biosimilar (Herzuma®) Plus Treatment of Physician's Choice (TPC) in Patients With HER-2 Positive Metastatic Breast Cancer (NCT NCT03755141)

Results Overview

defined as the time from study entry until the first observation of existing disease progression according to the above schedule or death due to any cause.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

109 participants

Primary outcome timeframe

6 months after last patient enrollment

Results posted on

2025-07-22

Participant Flow

Participant milestones

Participant milestones
Measure	Herzuma Herzuma + TPC Herzuma: Herzuma + Treatment of Physician's Choice
Overall Study STARTED	109
Overall Study COMPLETED	109
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy and Safety of Trastuzumab Biosimilar (Herzuma®) Plus Treatment of Physician's Choice (TPC) in Patients With HER-2 Positive Metastatic Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Herzuma n=109 Participants Herzuma + TPC Herzuma: Herzuma + Treatment of Physician's Choice
Age, Continuous	55 years n=5 Participants
Sex: Female, Male Female	109 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	109 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment South Korea	109 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months after last patient enrollment

defined as the time from study entry until the first observation of existing disease progression according to the above schedule or death due to any cause.

Outcome measures

Outcome measures
Measure	Herzuma n=109 Participants Herzuma + TPC Herzuma: Herzuma + Treatment of Physician's Choice
Progression Free Survival	4.6 months Interval 2.8 to 7.2

Adverse Events

Herzuma

Serious events: 42 serious events

Other events: 29 other events

Deaths: 37 deaths

Serious adverse events

Serious adverse events
Measure	Herzuma n=109 participants at risk Herzuma + TPC Herzuma: Herzuma + Treatment of Physician's Choice
Cardiac disorders cardiac event	0.92% 1/109 • 6 months
Blood and lymphatic system disorders hematologic event	35.8% 39/109 • 6 months
Gastrointestinal disorders non-hematologic event	1.8% 2/109 • 6 months

Other adverse events

Other adverse events
Measure	Herzuma n=109 participants at risk Herzuma + TPC Herzuma: Herzuma + Treatment of Physician's Choice
Blood and lymphatic system disorders hematologic event	15.6% 17/109 • 6 months
Gastrointestinal disorders non-hematologic event	9.2% 10/109 • 6 months
Cardiac disorders cardiac event	1.8% 2/109 • 6 months

Additional Information

In Hae Park

Korea university Guro hospital

Phone: +82-2-2626-3172

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place