Trastuzumab Emtansine(T-DM1) After Trastuzumab Deruxtecan(T-DXd) in HER2-Positive Breast Cancer in Korea

NCT06928818 | Recruiting

• 1 other identifier: H-2412-069-1597
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective observational study of trastuzumab emtansine immediately after trastuzumab deruxtecan in patients with advanced HER2-positive breast cancer in Korea

Conditions

Cancer of Breast; Trastuzumab Emtansine; Trastuzumab Deruxtecan

Outcome Measures

Primary Outcomes (1)

• progression-free survival (PFS)

  PFS will be assessed by physicians as per routine clinical practice. CT and/or MRI scans will be at baseline and every 2-4 cycles at the treating physician's discretion, reflecting the observational study design.

  PFS is defined as the time from treatment initiation to the first occurrence of disease progression or death from any cause, whichever occurs first, assessed up to 12 months.

Secondary Outcomes (6)

• objective response rate (ORR)

  12-month

• 12-month survival rate

  12-month

• time-to-discontinuation (TTD)

  12-month

• time-to-next-line-treatment (TTNT)

  12-month

• Duration of therapy (DoT)

  12-month

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

* Signed Informed Consent Form, when the patient is alive and not lost to follow- up. * Age ≥ 19 years old. * Histologically or cytologically confirmed, HER2-positive advanced breast cancer which is either locally advanced precluding resection or metastatic. * Prior treatment with T-Dxd in the advanced setting * Intention to treat with T-DM1 as next therapy upon progression from T-Dxd Patients who meet any of the following criteria will be excluded from study entry: * Any systemic treatment, other than T-DM1, for breast cancer after T-Dxd (With an exception, endocrine agents not in combination with cytotoxics or antibody-drug conjugates will be permitted in the study) * Has been previously treated with T-DM1 for advanced breast cancer * Has been previously treated with 4 or more lines of therapy for advanced breast cancer

You may qualify if:

• HER2-positive, advanced (unresectable locally advanced or metastatic) breast cancer
• Prior treatment with trastuzumab deruxtecan(T-DXd) in the advanced setting
• Intention to treat with Trastuzumab Emtansine (T-DM1) as first therapy upon T-DXd progression

You may not qualify if:

• Any systemic treatment, other than T-DM1, for breast cancer after trastuzumab deruxtecan (As an exception, patients treated with endocrine agents, not in combination with cytotoxics or antibody-drug conjugates, will be permitted in the study)
• Has been previously treated with T-DM1 for advanced breast cancer
• Has been previously treated with 4 or more lines of therapy for advanced breast cancer
• Half (50%) or more patients will be those who were treated with second-line trastuzumab deruxtecan (i.e. patients at the later line will be capped).

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Kyung-Hun Lee, MD, PhD

CONTACT

82-2-2072-7207; kyunghunlee@snu.ac.kr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 31, 2025
• First Posted: April 15, 2025
• Study Start: February 26, 2025
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2029
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

KR (1)