The safety and efficacy of this agent(s), or use in this setting, has not been established or is subject to confirmation. For an agent(s) whose safety and efficacy has not been established or confirmed, future regulatory approval or commercial availability is not guaranteed.
Active Not-enrolling
United States, Belgium, Germany, Italy, Japan, Korea, Republic of, Netherlands, Poland, Spain, United Kingdom
for more information at clinicaltrials.gov
EXPERIMENTAL: Tucatinib + Trastuzumab (+ Fulvestrant)
Tucatinib + trastuzumab (+ fulvestrant in hormone-receptor positive HER2-mutant breast cancer only)
DRUG: tucatinib
300 mg orally twice daily
DRUG: trastuzumab
Given into the vein (intravenously; IV). 8mg/kg IV on Cycle 1 Day 1, and 6mg/kg every 21 days starting on Cycle 2 Day 1
DRUG: fulvestrant
Given into the muscle (intramuscular; IM) once every 4 weeks starting from Cycle 1 Day 1, plus one dose on Cycle 1 Day 15. Only administered to participants with hormone-receptor positive breast cancer.
Inclusion Criteria
Confirmed objective response rate (cORR) per investigator assessment
cORR is defined as the proportion of participants with best overall response of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
From start of treatment up to approximately 2 years
Disease control rate (DCR) per investigator assessment
DCR is defined as the proportion of participants with confirmed CR, confirmed PR, or stable disease according to RECIST v1.1
From start of treatment up to approximately 2 years
Duration of response (DOR) per investigator assessment
DOR is defined as the time from first documentation of objective response of confirmed CR or confirmed PR to the first documentation of disease progression per RECIST v1.1 or death from any cause, whichever occurs first.
From start of treatment up to approximately 2 years
Progression-free survival (PFS) per investigator assessment
PFS is defined as the time from the date of treatment initiation to the date of disease progression according to RECIST v1.1 or death from any cause, whichever occurs first.
From start of treatment up to approximately 2 years
Overall survival (OS)
OS is defined as the time from treatment initiation to death due to any cause.
From start of treatment up to approximately 4 years
Incidence of adverse events (AEs)
Any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
From start of treatment up to approximately 2 years
Incidence of laboratory abnormalities
To be summarized using descriptive statistics.
From start of treatment up to approximately 2 years
Incidence of dose alterations
From start of treatment up to approximately 2 years
Maximum concentration (Cmax)
To be summarized using descriptive statistics.
Approximately 4 months, during first 6 cycles of treatment
Trough concentration (Ctrough)
To be summarized using descriptive statistics.
Approximately 4 months, during first 6 cycles of treatment
217
Sponsor: Seagen Inc.
Collaborator: None
For more information, call or email the Pfizer Clinical Trial Contact Center:
When calling, please reference this study number:
NCT# stands for National Clinical Trial number. This is a unique identification code given to each clinical trial registered on ClinicalTrials.gov. The format is "NCT" followed by an 8-digit number (for example, NCT00000419). Also called the ClinicalTrials.gov identifier.
NCT04579380
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