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A real-world prospective observational study of T-DM1 in patients with HER2-positive advanced breast cancer

A real-world prospective observational study of T-DM1 in patients with HER2-positive advanced breast cancer

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300077438
Enrollment
Unknown
Registered
2023-11-08
Start date
2023-11-13
Completion date
Unknown
Last updated
2023-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

breast cancer

Interventions

Observation Group:NA

Sponsors

Army Medical Center of PLA
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Voluntarily join the study, sign informed consent, have good compliance and be willing to cooperate with follow-up; 2. Tumor biopsy confirmed HER2-positive breast cancer; 3. HER2-positive, unresectable locally advanced or metastatic breast cancer previously treated with anti-HER2 drugs and purple shirtanes. Patients include: prior treatment for locally advanced or metastatic disease or disease recurrence during completion of adjuvant therapy or within six months; 4. Plan to receive T-DM1 treatment; 5. ECOG score 0-1; 6. Female, older than 18 years old; 7. Willing to undergo tumor evaluation and blood sample collection during the study.

Exclusion criteria

Exclusion criteria: 1. Failure to sign informed consent; 2. Pregnant or lactating women; 3. The patient has severe concomitant medical conditions, or any other condition in which the investigator believes that the patient is not suitable to participate in this study.

Design outcomes

Primary

MeasureTime frame
Real-world progression-free survival (rwPFS);

Secondary

MeasureTime frame
Objective Response Rate (ORR);Disease Control Rate (DCR);Time to stop treatment (TTD);Duration of mitigation (DoR);

Countries

China

Contacts

Public ContactYan Xu

Army Medical Center of PLA

690476535@qq.com+86 159 2310 0038

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026