Registered outcomes16

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 16 of 16

List	Outcome	Time frame	Description
Primary	Progression Free Survival (PFS) in HER2 IHC 1+/2+/3+ population	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years.	Defined as the time from the date of randomization until first documentation of disease progression, as determined by investigator assessment based on RECIST 1.1, or death due to any cause, whichever occurs first.
Secondary	Progression Free Survival (PFS) in HER2 IHC 2+/3+ population	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years.	Defined as the time from the date of randomization until first documentation of disease progression, as determined by investigator assessment based on RECIST 1.1, or death due to any cause, whichever occurs first
Secondary	Objective Response Rate (ORR) by investigator in HER2 2+/3+ population	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years.	Defined as the proportion of patients who have best overall response of either complete response (CR) or partial response (PR), as investigator assessment based on RECIST 1.1
Secondary	Objective Response Rate (ORR) by investigator in HER2 1+/2+/3+ population	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years.	Defined as the proportion of patients who have best overall response of either complete response (CR) or partial response (PR), as investigator assessment based on RECIST 1.1
Secondary	Disease control rate (DCR) by investigator in HER2 2+/3+ population	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years.	Defined as the proportion of patients who have best overall response of CR, PR, or stable disease (SD) by investigator assessment per RECIST 1.1 . SD must be achieved at ≥ 7 weeks after randomization to be considered best overall response.
Secondary	Disease control rate (DCR) by investigator in HER2 1+/2+/3+ population	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years.	Defined as the proportion of patients who have best overall response of CR, PR, or stable disease (SD) by investigator assessment per RECIST 1.1 . SD must be achieved at ≥ 7 weeks after randomization to be considered best overall response.
Secondary	Clinical benefit rate (CBR) by investigator in HER2 2+/3+ population	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years.	Defined as the proportion of patients who have best overall response of CR, PR, or stable disease (SD) by investigator assessment per RECIST 1.1 . (duration of SD ≥ 23 weeks after randomization)
Secondary	Clinical benefit rate (CBR) by investigator in HER2 1+/2+/3+ population	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years.	Defined as the proportion of patients who have best overall response of CR, PR, or stable disease (SD) by investigator assessment per RECIST 1.1 . (duration of SD ≥ 23 weeks after randomization)
Secondary	Duration of Response Rate (DoR) by investigator in HER2 2+/3+ population	From the time of first documentation of CR or PR until the time of first documentation of subsequent PD or death from any cause, whichever came first, assessed up to 5 years.	Measured from the time of initial response until documented tumor progression.
Secondary	Duration of Response Rate (DoR) by investigator in HER2 1+/2+/3+ population	From the time of first documentation of CR or PR until the time of first documentation of subsequent PD or death from any cause, whichever came first, assessed up to 5 years.	Measured from the time of initial response until documented tumor progression.
Secondary	Time to first subsequent treatment (TFST) Time to second Subsequent Treatment (TSST) in HER2 2+/3+ population	From the date of randomization to date of the first and second subsequent anticancer therapy or death, whichever came first, assessed up to 5 years.	Defined as the time from the date of randomization to date of the first and second subsequent anticancer therapy or death.
Secondary	Time to first subsequent treatment (TFST) Time to second Subsequent Treatment (TSST) in HER2 1+/2+/3+ population	From the date of randomization to date of the first and second subsequent anticancer therapy or death, whichever came first, assessed up to 5 years.	Defined as the time from the date of randomization to date of the first and second subsequent anticancer therapy or death.
Secondary	Progression free survival 2 (PFS2) measured by investigator in HER2 1+/2+/3+ population	the time from treatment randomization to the earlier date of assessment of progression on the next anticancer therapy following study treatment or death by any cause, whichever came first, assessed up to 5 years.	Defined by the time from initial randomization to the second objective disease progression (ie, after the first subsequent therapy) or death.
Secondary	OS in the HER2 IHC 2+/3+ population	the time from the date of inclusion until death due to any cause, assessed up to 5 years.	Measured as the time from the date of randomization to the date of death
Secondary	OS in the HER2 IHC 1+/2+/3+ population	the time from the date of inclusion until death due to any cause, assessed up to 5 years.	Measured as the time from the date of randomization to the date of death
Secondary	Response rate of subsequent therapies	From the start date of subsequent anticancer therapy until death due to any cause or study termination, assessed up to 5 years.	Defined as the proportion of patients who have best overall response of either complete response (CR) or partial response (PR), as investigator assessment based on RECIST 1.1

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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