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Recruiting NCT06974929

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

Phase I / Phase II Interventional Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HRS-6209 Capsules, Letrozole Tablets, HRS-2189 Tablets.
Who it may be relevant to
Registry conditions: Breast Cancer. Basic parameters: 18 years — 75 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

An Open-Label, Multicenter Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HRS-6209 Combination Therapy in Patients With Breast Cancer

Overview

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.

Interventions

  • Drug HRS-6209 Capsules
    Oral HRS-6209 capsules.
  • Drug Letrozole Tablets
    Oral Letrozole tablets.
  • Drug HRS-2189 Tablets
    HRS-2189 tablets.

Primary outcome measures

  • Dose-limiting toxicity (DLT) [Time frame: 28 days after the first dose.]
  • Maximum tolerated dose (MTD) [Time frame: 28 days after the first dose.]
  • Recommended phase II dose (RP2D) [Time frame: 28 days after the first dose.]
  • Adverse events (AEs) [Time frame: About 1 year.]
  • Serious adverse events (SAEs) [Time frame: About 1 year.]
  • Objective response rate (ORR) [Time frame: About 1 year.]
Secondary outcome measures (4)
  • Best overall response (BOR) [Time frame: About 1 year.]
  • Duration of response (DoR) [Time frame: About 1 year.]
  • Clinical benefit rate (CBR) [Time frame: About 1 year.]
  • Progression-free survival (PFS) [Time frame: About 1 year.]

Eligibility criteria

Inclusion criteria

  • 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.
  • At baseline, there must be at least one measurable, extracranial lesion that meets RECIST v1.1 criteria.
  • Expected survival > 3 months.
  • Women of childbearing potential must agree to use highly effective contraceptive measures during the study treatment and for 6 months after the end of treatment. Women of childbearing potential must have a negative serum HCG test within 7 days prior to study enrollment and must not be breastfeeding.
  • Voluntarily agree to participate in this clinical trial, willing and able to comply with the study visits and procedures, understand the study procedures, and have signed the informed consent form.

Exclusion criteria

  • 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.
  • The subjects were in acute infection or active tuberculosis and needed drug treatment.
  • The patients received surgery, chemotherapy, immunotherapy and macromolecular targeted therapy within 4 weeks before the first medication.
  • Pregnant and lactating women, or intending to become pregnant during the study.
  • There was a clear history of neurological or mental disorders and the subjects had a history of psychotropic drug abuse or drug abuse.
  • In the course of this study, it is expected to receive other anti-tumor treatments or drugs.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Tianjin Medical University Cancer Institute and Hospital — Tianjin

Identifiers

NCT: NCT06974929 · HRS-6209-203

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗