Active — Not RecruitingPhase 3

Trastuzumab Deruxtecan (DS-8201a) Versus Investigator's Choice for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed [DESTINY-Breast04]

United States557 participantsStarted 2018-12-27

Plain-language summary

This study will compare DS-8201a to physician choice standard treatment. Participants must have HER2-low breast cancer that has been treated before. Participants' cancer: * Cannot be removed by an operation * Has spread to other parts of the body

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Is unresectable or metastatic
✓. Has low-HER2 expression defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested)
✓. Is HR-positive or HR-negative
✓. Has progressed on, and would no longer benefit from, endocrine therapy
✓. Has been treated with 1 to 2 prior lines of chemotherapy/adjuvant in the recurrent or metastatic setting
✓. Was never previously HER2-positive (ICH 3+ or ISH+) on prior pathology testing (per American Society of Clinical Oncology-College of American Pathologists \[ASCO-CAP\] guidelines)
✓. assessment of HER2 status
✓. assessment of post-treatment status

What they're measuring

Progression-free Survival (PFS) Based on Blinded Independent Central Review (BICR) in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer

Timeframe: From the date of randomization to the earliest date of the first objective documentation of radiographic disease progression or death due to any cause, up to approximately 3 years

Trial details

NCT IDNCT03734029

SponsorDaiichi Sankyo

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-01-11

Results submitted2023-01-11

View on ClinicalTrials.gov More Breast Cancer trials