The Clinical Study of the Efficacy and Safety of Trop2-ADC Monotherapy or Combination Immunotherapy Strategy in the Treatment of Advanced Triple-negative Breast Cancer.

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University

About this trial

This is a prospective, multicenter, randomized controlled study aimed at evaluating the efficacy and safety of Trop2-ADC monotherapy or immune combination strategy in the treatment of advanced triple-negative breast cancer.

Eligibility criteria

Qualifiers

1) adult female patients (aged 18-70 years) with metastatic triple negative breast cancer confirmed by pathology or imaging;

2) no more than two previous lines of therapy for metastatic disease;

3) ECOG performance status ≤2 and expected survival time ≥ 3 months;

4) At least one measurable lesion on imaging within 2 weeks before enrollment; Or simple bone metastases;

Disqualifiers

1) patients with a known allergy to the active ingredient or other ingredient of the study drug.

2) patients with known resistance to trop2-ADC drugs. 、

3) receiving radiotherapy, chemotherapy, or endocrine therapy within 4 weeks before enrollment, or participating in any interventional drug clinical trial;

4) pregnant or lactating women or women of childbearing age who refused to use effective contraception during the study period.

Trial design

Treatments tested in this trial

  • trop2-ADC
  • ADC +anti-angiogenic drug
  • ADC + PD1 monoclonal antibody +anti-angiogenic drug

Treatment groups

60 Participants
are divided into 3 treatment groups