A Clinical Study of HRS-6209 Combined With Other Treatment Regimens in Patients With Breast Cancer

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

About this trial

This is a study to evaluate the safety, tolerability, and pharmacokinetic characteristics of HRS-6209 combined with other treatment regimens in breast cancer patients, and preliminarily observe its anti-tumor efficacy.

Eligibility criteria

Qualifiers

Women aged 18-75 years.

ECOG performance status 0-1.

Menopausal status.

Evidence of radiographic disease progression during or after the last systemic anti-tumor therapy prior to the first study drug administration.

Disqualifiers

Symptomatic visceral metastasis and other conditions, and the researcher judged that endocrine therapy was not suitable for use.

History of clinically serious cardiovascular disease.

The ECG examination was abnormal.

Patients with clinically significant endometrial abnormalities, including but not limited to endometrial hyperplasia and dysfunctional uterine bleeding.

Trial design

Treatments tested in this trial

  • HRS-6209 Capsules
  • Letrozole Tablets
  • HRS-2189 Tablets

Treatment groups

80 Participants
are divided into 2 treatment groups