The Rechallenge of ADCs in MBC Patients

Active, not recruiting

• Conditions: Breast Cancer
• Interventions: Drug: ADC

• Registration Number: NCT05571618
• Lead Sponsor: Fudan University

Brief Summary

To investigate the efficacy and safety of ADC rechallenge

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-01
• Study First Submitted: 2022-10-05
• Study First Submitted QC: 2022-10-05
• Study First Posted: 2022-10-07
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-17
• Last Update Posted: 2024-10-21
• Primary Completion: 2025-01-01
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• age > 18 years old.
• Diagnosed with Metastatic Breast Cancer.
• Patients with prior exposure to ADC (either in the adjuvant setting or metastatic disease are allowed).
• Patients plan to or have received ADCs for the second or more time.
• Complete medical history was available.

Exclusion Criteria

• Medical history was incomplete

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group1	ADC	-

Primary Outcome Measures

Name	Time	Method
PFS	6 weeks	Progression free survival

Secondary Outcome Measures

Name	Time	Method
ORR	6 weeks	Objective Response Rate
CBR	6 weeks	Clinical Benefit Rate
Adverse events	6 weeks	Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
DoR	6 weeks	Duration of Response
OS	6 weeks	Overall Survival

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China