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NCT07389733RecruitingPhase 1/2

A Study of HRS-6208 in Combination With HRS-8080, or Fulvestrant, or Letrozole, With or Without HRS-6209 in Patients With Advanced Unresectable or Metastatic Breast Cancer

Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HRS-6208 in Combination With HRS-8080 ± HRS-6209, or in Combination With Fulvestrant ± HRS-6209, or in Combination With Letrozole ± HRS-6209 in Patients With Advanced Unresectable or Metastatic Breast Cancer: an Open Label, Multicenter, Phase Ib/II Study

Source: ClinicalTrials.gov · Last updated 3 Apr 2026

Brief summary (registry, in English)

This study aims to evaluate the safety, tolerability, efficacy and pharmacokinetics of HRS-6208 in combination with HRS-8080 ± HRS-6209, or in combination with fulvestrant ± HRS-6209, or in combination with letrozole ± HRS-6209 in patients with advanced unresectable or metastatic breast cancer.

Status (registry)
Recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
180 (estimated)
First submitted
29 Jan 2026
Start date
27 Mar 2026
Primary completion date
31 Dec 2028
Lead sponsor
Shandong Suncadia Medicine Co., Ltd.
NCT number
NCT07389733

What you commit to

  • Study type: Interventional · Phase 1/2
  • Planned participants: 180
  • From 27 Mar 2026 to the primary completion date, 31 Dec 2028
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Within 5 years prior to the first dose of study medication, the occurrence of other malignancies, except for fully treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, and post-radical surgery thyroid papillary carcinoma;
  • Adverse events caused by previous anti-tumor treatment have not been resolved;
  • Participants with one of multiple factors affecting oral medication;
  • Significant clinically meaningful bleeding within 3 months prior to the first dose of study medication;
  • History of active tuberculosis infection within 1 year prior to enrollment, or history of active tuberculosis infection more than 1 year ago without standard treatment;
  • Washout period of prior drug or treatment did not meet protocol requirements before the first dose of study medication;
  • Prior use of prohibited drugs specified in the protocol;
  • Is pregnant or breastfeeding or planning to become pregnant within 2 years after the last dose of study medication;

Other illness

  • Active brain metastasis, carcinomatous meningitis, spinal cord compression, or history of primary central nervous system tumors;
  • History of severe cardiovascular and cerebrovascular diseases;
  • Presence of severe infections;
  • Active autoimmune diseases, history of immune deficiency, history of autoimmune diseases, or history of diseases or syndromes requiring systemic steroid hormone or immunosuppressive drug treatment, or acquired conditions (HIV infection), congenital immune deficiency diseases, or history of organ transplantation;
  • Active untreated hepatitis;
  • History of clear neurological or psychiatric disorders, and participants with a history of psychiatric drug abuse or drug addiction;
  • Allergic reactions to any study drug or excipients;

Other

  • Severe bone damage caused by tumor bone metastasis as determined by the investigator;
  • Factors confirmed by the investigator as unsuitable for participation in this clinical study.

Who the study is looking for

  • Female, aged 18-75 (inclusive);
  • ECOG score 0-1;
  • Estimated survival time ≥ 12 weeks;
  • Possessing adequate bone marrow and organ function;
  • Participants of reproductive/childbearing potential must agree to take adequate and effective contraceptive measures from the time they sign the informed consent form, during the study treatment period, and up to 2 years after the last use of the trial medication;
  • Participants must provide informed consent for this study before the trial and voluntarily sign a written informed consent form.

Age in the registry: 18 years to 75 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
West China Hospital,Sichuan University
Coordinator of this site? Confirm its status
ChengduChinaRecruiting
The Second Affiliated Hospital of Dalian Medical University
Coordinator of this site? Confirm its status
DalianChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.