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The Rechallenge of ADCs in MBC Patients

A Multicenter, Real-world Study of the Efficacy and Safety of Antibody-drug Conjugates (ADCs) Rechallenge in Patients with Prior Exposure to ADCs Metastatic Breast Cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05571618
Enrollment
100
Registered
2022-10-07
Start date
2022-09-01
Completion date
2025-03-01
Last updated
2024-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Antibody-drug conjugates, Metastatic Breast Cancer

Brief summary

To investigate the efficacy and safety of ADC rechallenge

Interventions

DRUGADC

Patients with prior exposure to ADC (either in the adjuvant setting or metastatic disease are allowed).

Sponsors

Fudan University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
PFS6 weeksProgression free survival

Secondary

MeasureTime frameDescription
ORR6 weeksObjective Response Rate
CBR6 weeksClinical Benefit Rate
DoR6 weeksDuration of Response
Adverse events6 weeksNumber of participants with treatment-related adverse events as assessed by CTCAE v5.0
OS6 weeksOverall Survival

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026