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Life sciences · Phase 3 Trial
ClinicalTrials.gov · September 29, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 3 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT05132582). This is a study registration, not published results. Lead sponsor: Seagen, a wholly owned subsidiary of Pfizer. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 654 participants (ACTUAL). Conditions: HER2 Positive Breast Cancer. Interventions: DRUG: Tucatinib; DRUG: Trastuzumab; DRUG: Pertuzumab; DRUG: Combination product: Trastuzumab + Pertuzumab; DRUG: Placebo. Primary outcome measures: Progression-Free Survival (PFS) as Assessed by Investigator Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 , From randomization until the first documentation of PD or death from any cause or censoring date, whichever occurred first (maximum treatment exposure was of 41.3 months). Brief summary: This study is being done to see if tucatinib works better than placebo when given with other drugs to treat participants with HER2-positive breast cancer. A placebo is a pill that looks the same as tucatinib but has no medicine in it. This study will also test what side effects happen when participants take this combination of drugs. A side effect is anything a drug does to the body besides treating your disease. Participants will have cancer that has spread in the body near where it started (locally advanced) and cannot be removed (unresectable) or has spread through the body (metastatic). In this study, all participants will get either tucatinib or placebo. Participants will be assigned randomly to a group. This is a blinded study, so patients and their doctors will not know which group a participant is in. All participants will also get trastuzumab and pertuzumab. These are 2 drugs used to treat this type of cancer.