Trastuzumab Deruxtecan in Advanced Breast Cancer

NCT07180264 | Recruiting DMC

• 1 other identifier: LY2025-137-B
• Study Type: observational
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the efficacy and safety of trastuzumab deruxtecan in advanced breast cancer patients.

Conditions

Advanced Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  The time from the date of starting trastuzumab deruxtecan to the date of disease progression as per RECIST version 1.1 or death from any cause, whichever occurs first.

  From the date of starting Disitamab vedotin to the date of first documentation of progression or death (up to approximately 1 years)

Secondary Outcomes (1)

• Adverse events

  From the date of starting trastuzumab deruxtecan to the end of the treatment (up to approximately 1 year)

Study Arms (1)

Trastuzumab deruxtecan

Trastuzumab deruxtecan, recommended dose 5.4mg/kg, every 21 days

Drug: Trastuzumab deruxtecan

Interventions

Trastuzumab deruxtecan DRUG

Trastuzumab deruxtecan is a combination of the targeted cancer drug trastuzumab (also known as Herceptin) and a chemotherapy drug called deruxtecan or DXd.

Trastuzumab deruxtecan

Eligibility Criteria

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

Study Population

Breast cancer patients meeting current guideline recommendations and planning to receive trastuzumab deruxtecan

You may qualify if:

• Aged ≥18 and older
• Breast cancer patients meeting current guideline recommendations and planning to receive trastuzumab deruxtecan
• ECOG 0-1

You may not qualify if:

• During pregnancy and lactation

Sponsors & Collaborators

• Wenjin Yin: lead

Study Sites (1)

Renji Hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, 200127, China

RECRUITING

MeSH Terms

Interventions

trastuzumab deruxtecan

Study Officials

• Wenjin Yin, M.D.

  Renji Hospital,School of Medicine, Shanghai Jiaotong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenjin Yin, M.D.

CONTACT

86(21)68385569; yinwenjin@renji.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy Chief of Breast Surgery Department

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: September 18, 2025
• Study Start: August 28, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2029
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)