Active — Not RecruitingPhase 3

Trastuzumab Deruxtecan (T-DXd) With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive Metastatic Breast Cancer (DESTINY-Breast09)

United States1,157 participantsStarted 2021-04-26

Plain-language summary

The study will evaluate the efficacy and safety of trastuzumab deruxtecan (also known as T-DXd, DS-8201a), either alone or in combination with pertuzumab, in treating patients with Human epidermal growth factor receptor 2 (HER2)-positive breast cancer as a first line of treatment in the metastatic setting.

Who can participate

Age range18 Years – 130 Years

SexALL

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Inclusion criteria

✓. is advanced or metastatic
✓. is locally assessed and prospectively centrally confirmed as HER2-positive (IHC3+ or ISH+)
✓. is documented by local testing as hormone receptor (HR)-positive or HR-negative disease in the metastatic setting

What they're measuring

Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) assessment

Timeframe: Until progression or death, assessed up to approximately 60 months

Trial details

NCT IDNCT04784715

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-07-06

View on ClinicalTrials.gov More Breast Cancer; HER2-positive; Metastatic trials