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Recruiting

NCT Number: NCT05851677

Disitamab Vedotin (RC48-ADC) in Breast Cancer

To evaluate the efficacy and safety of Disitamab vedotin (RC48-ADC) in patients with breast cancer.

Recruiting

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Key information

Conditions

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

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

  • Histologically confirmed breast cancer;
  • Prior or current use of Disitamab vedotin (RC48-ADC);

Exclusion criteria

  • Participating in clinical trials involving Disitamab vedotin (RC48-ADC) or not.

Treatment and study plan

Disitamab Vedotin

Drug

recommended but not required regimen of 2.0mg/kg, iv, day1, every 2 weeks

Other names: RC48-ADC

Primary outcomes

  1. Progression-Free Survival

    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 Disitamab Vedotin 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 Disitamab vedotin to the end of the treatment (up to approximately 1 year)

    Adverse events during Disitamab Vedotin regimen 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

RenJi Hospital

Other

Registry information

Official study title

Disitamab Vedotin (RC48-ADC) in Patients With Breast Cancer: a Real-world Study

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
May 10, 2023
Registry last updated
Sep 17, 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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