NCT07035353

A Real-world Clinical Study of T-DXd for the Treatment of Chinese Patients With HER2 Overexpressing and HER2 Underexpressing Advanced Breast Cancer

A Clinical Study Evaluating the Efficacy and Safety of Real-world T-DXd in Treating Chinese Patients With HER2 Overexpression and HER2 Underexpression Advanced Breast Cancer

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study is an open, prospective study to collect data on the efficacy and safety of T-DXd (DS8201) in Chinese patients with HER2 overexpressing and HER2 underexpressing advanced breast cancer in actual clinical practice in China. Cohort A: HER2 overexpressing patients with advanced breast cancer Cohort B: HER2 underexpressing patients with advanced breast cancer A total of 400 subjects will be enrolled in the program, with 200 enrolled in Cohort A and 200 enrolled in Cohort B. The study will be conducted by a physician in accordance with current clinical practice. The treatment plan will be recommended to the subjects by the treating physician based on the current clinical practice guidelines in conjunction with the clinical practice, and the patient's decision to be treated with T-DXd (DS8201) should precede enrollment in this study. Because of the non-interventional nature of this study, this study does not alter or interfere with clinician treatment decisions, and the actual medical practice of patients. Inclusion in the study after the first treatment with the drug is based on inclusion/exclusion criteria. Subject enrollment in this study should be within 2 months of the subject's first dose of medication and prior to the first efficacy assessment. Demographic data, past medical and treatment history, ECOG score, vital signs + physical examination, laboratory tests, objective tumor evaluation, coadministration/concomitant therapy, adverse events, time to progression/death, and subsequent antitumor therapy were collected at baseline, during treatment, and at subsequent follow-up. Imaging evaluation was performed according to RECIST 1.1 criteria. Adverse events evaluation criteria were based on NCI-CTCAE version 5.0.

Conditions

• HER2 Overexpression
• Advanced Stage Breast Cancer
• Low Expression of HER2

Interventions

Type	Name	Description
DRUG	T-DXd (DS8201) 5.4 mg/kg, IVD, 1 cycle every 21 days.	The treatment plan will be recommended to the subject by the treating physician in accordance with current clinical practice guidelines and clinical practice, and the patient's decision to receive T-DXd (DS8201) should precede enrollment in this study. The strategy for administering a particular treatment to a subject is not determined a priori by the trial protocol, but should be in accordance with current clinical practice. Because of the non-interventional nature of this study, this study does not alter or interfere with the patient's actual current medical practice.

Timeline

• Start date: 2025-06-30
• Primary completion: 2028-05-01
• Completion: 2035-05-01
• First posted: 2025-06-25
• Last updated: 2025-06-25