Disitamab Vedotin (RC48-ADC) in Breast Cancer

NCT ID: NCT05851677

Last Updated: 2025-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-01

Study Completion Date

2027-08-31

Brief Summary

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

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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RC48-ADC

RC48-ADC for breast cancer

Disitamab vedotin

Intervention Type DRUG

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

Interventions

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Disitamab vedotin

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

Intervention Type DRUG

Other Intervention Names

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RC48-ADC

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RenJi Hospital

OTHER

Sponsor Role lead

Responsible Party

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Wenjin Yin

Deputy Chief of Breast Surgery Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wenjin Yin, M.D.

Role: PRINCIPAL_INVESTIGATOR

Renji Hospital,School of Medicine, Shanghai Jiaotong University

Locations

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Renji Hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wenjin Yin, M.D.

Role: CONTACT

86(21)68385569

Facility Contacts

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Wenjin Yin

Role: primary

86(21)68385569

Other Identifiers

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LY2023-062-B

Identifier Type: -

Identifier Source: org_study_id

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