Health Trials

About this trial

This multi-center observational prospective study will collect real-world clinical and patient-reported outcome data from eligible patients with unresectable or metastatic HER2+ breast cancer who have received one or more prior anti-HER2-based regimens or patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+, ISH-) breast cancer who have received at least a prior systemic therapy in the metastatic setting, or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy.

Eligibility criteria

Qualifiers

≥18 years of age at time of consent.

Pathologically documented breast cancer that is unresectable or metastatic.

Cohort A: Patients with confirmed HER2+ (IHC 3+ or IHC2+, ISH+); and patients have received one or more prior anti-HER2-based regimens; and patients should have received no more than 2 lines therapy in the metastatic settings.

Decision to newly initiate T-DXd or just have started the first dose no longer than 14 days after the index date per approved label in China.

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Trastuzumab deruxtecan

Treatment groups

800 Participants
are divided into 2 treatment groups

Locations

54
Beijing GoBroad Hospital102206, Beijing China
China-Japan Friendship Hospital100029, Beijing China
Peking University First Hospital100034, Beijing China
Peking University Shougang Hospital100144, Beijing China

Sponsors and collaborators

Daiichi Sankyo

Lead sponsor

Source ClinicalTrials.gov