A Study of SHR-A1811 and Fulvestrant, With or Without HS-10352, in Locally Advanced or Metastatic Breast Cancer Patients

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorHenan Cancer Hospital

About this trial

This study is being conducted to evaluate the efficacy and safety of SHR-A1811 and Fulvestrant in Combination with or without HS-10352 in locally advanced or metastatic breast cancer patients. Subjects will receive SHR-A1811 and Fulvestrant in Combination with or without HS-10352.

Eligibility criteria

Qualifiers

Female patients aged ≥18 years and ≤75 years;

ECOG Performance Status of 0 -2;

Locally advanced/metastatic breast cancer not amenable to curative therapy

Disease progression during treatment or within 12 months of completing adjuvant therapy ;

Disqualifiers

Breast cancer that has not been histologically confirmed;

Inflammatory breast cancer;

Participants ineligible for endocrine therapy due to any disease burden, as judged by the investigator;

Meningeal metastasis or active parenchymal brain metastasis;

Trial design

Treatments tested in this trial

  • SHR-A1811+ Fulvestrant
  • SHR-A1811+ Fulvestrant+HS-10352

Treatment groups

52 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators