RC48-ADC in Breast Cancer

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05851677
• Other study ID #: LY2023-062-B
• Status: Recruiting
• Start date: June 1, 2023
• Est. completion date: August 2027

Study information

• Verified date: November 2023
• Source: RenJi Hospital
• Contact: Wenjin Yin, M.D.
• Phone: 86(21)68385569
• Email: yinwenjin[@]renji.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: August 2027
• Est. primary completion date: March 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Disitamab vedotin
recommended but not required regimen of 2.0mg/kg, iv, day1, every 2 weeks

Locations

Country	Name	City	State
China	Renji Hospital, School of Medicine, Shanghai Jiaotong University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-Free Survival	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.	From the date of starting Disitamab vedotin to the date of first documentation of progression or death (up to approximately 1 years)
Secondary	Adverse events	Adverse events during Disitamab Vedotin regimen will be assessed according to the NCI CTCAE v5.0.	From the date of starting Disitamab vedotin to the end of the treatment (up to approximately 1 year)