A Trial of HRS-6209 in Combination With Fulvestrant, Letrozole, HRS-8080, or HRS-1358 in Breast Cancer Patients

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorJiangsu HengRui Medicine Co., Ltd.

About this trial

The study is being conducted to evaluate the safety, PK and efficacy of HRS-6209 in Combination with Fulvestrant, Letrozole, HRS-8080, or HRS-1358 for advanced unresectable or metastatic breast cancer

Eligibility criteria

Qualifiers

Females aged 18-75 years (inclusive);

ECOG performance status (PS) score of 0-1;

Patients with histopathologically confirmed metastatic or unresectable locally advanced breast cancer, histopathologically confirmed ER-positive or PR-positive;

Having had bilateral oophorectomy, or aged ≥ 60 years old; or

Disqualifiers

With symptomatic visceral metastases deemed unfit for endocrine therapy by the investigator;

With active brain metastases, carcinomatous meningitis, spinal cord compression, or a history of primary tumors of the central nervous system;

History of clinically significant cardiovascular disease;

Abnormal ECG findings, which are judged by the investigator to be clinically significantand and need to intervene ;

Trial design

Treatments tested in this trial

  • HRS-6209 in Combination with Fulvestrant
  • HRS-6209 in Combination with HRS-1358
  • HRS-6209 in Combination with Letrozole
  • HRS-6209 in Combination with HRS-8080
  • HRS-6209 in Combination with HRS-1358

Treatment groups

528 Participants
are divided into 5 treatment groups