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NCT Number: NCT06974929

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

Location status: Recruiting

Location contact

Jihui Hao

CONTACT

[email protected]

+86-022-23340123

Jihui Hao

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HRS-6209 Capsules

Drug

Oral HRS-6209 capsules.

Letrozole tablets

Drug

Oral Letrozole tablets.

HRS-2189 Tablets

Drug

HRS-2189 tablets.

Primary outcomes

  1. Dose-limiting toxicity (DLT)

    Time frame: 28 days after the first dose.

  2. Maximum tolerated dose (MTD)

    Time frame: 28 days after the first dose.

  3. Recommended phase II dose (RP2D)

    Time frame: 28 days after the first dose.

  4. Adverse events (AEs)

    Time frame: About 1 year.

  5. Serious adverse events (SAEs)

    Time frame: About 1 year.

  6. Objective response rate (ORR)

    Time frame: About 1 year.

Secondary outcomes

  1. Best overall response (BOR)

    Time frame: About 1 year.

  2. Duration of response (DoR)

    Time frame: About 1 year.

  3. Clinical benefit rate (CBR)

    Time frame: About 1 year.

  4. Progression-free survival (PFS)

    Time frame: About 1 year.

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 16, 2025
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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