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Recruiting

NCT Number: NCT07180264

Trastuzumab Deruxtecan in Advanced Breast Cancer

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

Recruiting

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Key information

Conditions

Advanced Breast Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Renji Hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, 200127, China

Location status: Recruiting

Location contact

Wenjin Yin

CONTACT

[email protected]

86(21)68385569

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • During pregnancy and lactation

Treatment and study plan

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.

Primary outcomes

  1. Progression-Free Survival (PFS)

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

    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.

Secondary outcomes

  1. Adverse events

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

    Adverse events during trastuzumab deruxtecan will be assessed according to the NCI CTCAE v5.0.

Study contacts

Contact information is provided by the study sponsor or research team.

Wenjin Yin, M.D.

CONTACT

[email protected]

86(21)68385569

Sponsors and collaborators

Lead sponsor

Wenjin Yin

Other

Registry information

Official study title

Trastuzumab Deruxtecan in Patients With Advanced Breast Cancer: a Real-world Study

Important dates

Study start
2025
Primary completion
2027
Study completion
2029
First posted
Sep 18, 2025
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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