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OpenTrials
Active, Not Recruiting

NCT Number: NCT05571618

The Rechallenge of ADCs in MBC Patients

To investigate the efficacy and safety of ADC rechallenge

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ADC

Drug

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

Primary outcomes

  1. PFS

    Time frame: 6 weeks

    Progression free survival

Secondary outcomes

  1. ORR

    Time frame: 6 weeks

    Objective Response Rate

  2. CBR

    Time frame: 6 weeks

    Clinical Benefit Rate

  3. DoR

    Time frame: 6 weeks

    Duration of Response

  4. Adverse events

    Time frame: 6 weeks

    Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

  5. OS

    Time frame: 6 weeks

    Overall Survival

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Oct 7, 2022
Registry last updated
Oct 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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