NCT05571618

Brief Summary

To investigate the efficacy and safety of ADC rechallenge

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 5, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 7, 2022

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

October 21, 2024

Status Verified

October 1, 2024

Enrollment Period

2.3 years

First QC Date

October 5, 2022

Last Update Submit

October 17, 2024

Conditions

Breast Cancer

Keywords

Antibody-drug conjugatesMetastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • PFS

    Progression free survival

    6 weeks

Secondary Outcomes (5)

  • ORR

    6 weeks

  • CBR

    6 weeks

  • DoR

    6 weeks

  • Adverse events

    6 weeks

  • OS

    6 weeks

Study Arms (1)

Group1

Drug: ADC

Interventions

ADCDRUG

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

Group1

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with breast cancer (according to ICD-10) with confirmed metastasis, regardless of being de novo diagnosed or progressed from a non-metastatic stage.

You may qualify if:

  • 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.

You may not qualify if:

  • Medical history was incomplete

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 5, 2022

First Posted

October 7, 2022

Study Start

September 1, 2022

Primary Completion

January 1, 2025

Study Completion

March 1, 2025

Last Updated

October 21, 2024

Record last verified: 2024-10

Locations

CN(1)