Study of SHR-A1921 Combined Adebrelimab in HR-positive, HER2-negative Advanced Breast Cancer

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorFudan University

About this trial

Our study is aimed to evaluate the efficacy and safety of novel ADC named SHR-A1921 combined with Adebrelimab in endocrine therapy-failed HR (Hormone Receptor)-positive, HER2-negative advanced breast cancer.

Eligibility criteria

Qualifiers

18 years to 75 years old, female patients with breast cancer;

ECOG PS Score: 0~1;

Histologically or cytologically confirmed HR-positive, HER2-negative advanced or metastatic breast cancer;

PD-L1 positive;

Disqualifiers

Has leptomeningeal metastasis confirmed by MRI or lumbar puncture;

Has CNS metastasis confirmed by radiology, except following conditions: ①asymptomatic brain metastasis that is not required to radiotherapy or surgery immediately; ②prior local therapy (e.g. radiotherapy or surgery) for brain or dural metastasis, of which stable disease lasting at least 4 weeks confirmed by radiography, and symptomatic therapy (e.g. hormone, mannitol, bevacizumab) has been stopped beyond 2 weeks with no clinical symptom;

Prior anti-TROP-2 treatment;

Has received or been receiving PD-(L)1 inhibitors and/or ADC containing a topoisomerase inhibitor-like payload;

Trial design

Treatments tested in this trial

  • SHR-A1921
  • Adebrelimab

Treatment groups

32 Participants
are divided into 1 treatment group

Sponsors and collaborators