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

March 30, 2026 updated by: Shandong Suncadia Medicine Co., Ltd.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Liaoning
      • Dalian, Liaoning, China, 116031
        • Recruiting
        • The Second Affiliated Hospital of Dalian Medical University
        • Principal Investigator:
          • Man Li
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China, 610044
        • Recruiting
        • West China Hospital, Sichuan University
        • Principal Investigator:
          • Ping Feng
        • Principal Investigator:
          • Ting Luo
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Female, aged 18-75 (inclusive);
  2. ECOG score 0-1;
  3. Estimated survival time ≥ 12 weeks;
  4. Possessing adequate bone marrow and organ function;
  5. 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;
  6. Participants must provide informed consent for this study before the trial and voluntarily sign a written informed consent form.

Exclusion Criteria:

  1. 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;
  2. Active brain metastasis, carcinomatous meningitis, spinal cord compression, or history of primary central nervous system tumors;
  3. Severe bone damage caused by tumor bone metastasis as determined by the investigator;
  4. Adverse events caused by previous anti-tumor treatment have not been resolved;
  5. Participants with one of multiple factors affecting oral medication;
  6. History of severe cardiovascular and cerebrovascular diseases;
  7. Presence of severe infections;
  8. Significant clinically meaningful bleeding within 3 months prior to the first dose of study medication;
  9. 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;
  10. Active untreated hepatitis;
  11. 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;
  12. Washout period of prior drug or treatment did not meet protocol requirements before the first dose of study medication;
  13. Prior use of prohibited drugs specified in the protocol;
  14. Is pregnant or breastfeeding or planning to become pregnant within 2 years after the last dose of study medication;
  15. History of clear neurological or psychiatric disorders, and participants with a history of psychiatric drug abuse or drug addiction;
  16. Allergic reactions to any study drug or excipients;
  17. Factors confirmed by the investigator as unsuitable for participation in this clinical study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm A: HRS-6208 + HRS-8080 ± HRS-6209
HRS-6208 + HRS-8080 ± HRS-6209.
Drug: HRS-6208 Capsule
HRS-6208 capsule.
Drug: HRS-6209 Capsule
HRS-6209 capsule.
Drug: HRS-8080 Tablet
HRS-8080 tablet.
Experimental: Arm B: HRS-6208 + Fulvestrant ± HRS-6209
HRS-6208 + Fulvestrant ± HRS-6209.
Drug: Fulvestrant injection
Fulvestrant injection.
Drug: HRS-6208 Capsule
HRS-6208 capsule.
Drug: HRS-6209 Capsule
HRS-6209 capsule.
Experimental: Arm C: HRS-6208 + Letrozole ± HRS-6209
HRS-6208 + Letrozole ± HRS-6209.
Drug: Letrozole tablets
Letrozole tablets.
Drug: HRS-6208 Capsule
HRS-6208 capsule.
Drug: HRS-6209 Capsule
HRS-6209 capsule.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Dose-limiting toxicity (DLT)
Time Frame: The DLT will be evaluated for the last participant in each dose group 28 days after the first dose.
The DLT will be evaluated for the last participant in each dose group 28 days after the first dose.
Recommended phase II dose (RP2D)
Time Frame: The evaluation of RP2D will be completed approximately one year later than DLT evaluation.
The evaluation of RP2D will be completed approximately one year later than DLT evaluation.
Incidence and severity of adverse events (AEs)
Time Frame: Each individual participant will be followed for approximately 8 months, and the entire study process will last for approximately 36 months.
Each individual participant will be followed for approximately 8 months, and the entire study process will last for approximately 36 months.
Objective response rate (ORR)
Time Frame: For a single subject, the duration will be approximately 8 months, while the entire research process will last for 36 months.
For a single subject, the duration will be approximately 8 months, while the entire research process will last for 36 months.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Disease control rate (DCR)
Time Frame: The duration for a single subject will be approximately 8 months, and the entire research process will last for 36 months.
The duration for a single subject will be approximately 8 months, and the entire research process will last for 36 months.
Duration of response (DoR)
Time Frame: The duration for a single subject will be approximately 8 months, and the entire research process will last for 36 months.
The duration for a single subject will be approximately 8 months, and the entire research process will last for 36 months.
Progression-free survival (PFS)
Time Frame: The duration for a single subject will be approximately 8 months, and the entire research process will last for 36 months.
The duration for a single subject will be approximately 8 months, and the entire research process will last for 36 months.
Overall survival (OS)
Time Frame: The duration for a single subject will be approximately 8 months, and the entire research process will last for 36 months.
The duration for a single subject will be approximately 8 months, and the entire research process will last for 36 months.
The blood drug concentration of HRS-6208
Time Frame: The duration for a single subject will be approximately 8 months, and the entire research process will last for 36 months.
The duration for a single subject will be approximately 8 months, and the entire research process will last for 36 months.
The blood drug concentration of HRS-8080
Time Frame: The duration for a single subject will be approximately 8 months, and the entire research process will last for 36 months.
The duration for a single subject will be approximately 8 months, and the entire research process will last for 36 months.
The blood drug concentration of HRS-6209
Time Frame: The duration for a single subject will be approximately 8 months, and the entire research process will last for 36 months.
The duration for a single subject will be approximately 8 months, and the entire research process will last for 36 months.
The blood drug concentration of Letrozole
Time Frame: The duration for a single subject will be approximately 8 months, and the entire research process will last for 36 months.
The duration for a single subject will be approximately 8 months, and the entire research process will last for 36 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shandong Suncadia Medicine Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 27, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 29, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 5, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HRS-6208-201-BC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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