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NCT Number: NCT07354022

A Study to Evluate Efficacy and Safety of HRS-8080 Combined With Dalpiciclib in Patients With Advanced or Metastatic Breast Cancer Resistant to Adjuvant Endocrine Therapy.

The study is being conducted to evaluate the efficacy and safety of HRS-8080 combined with dalpiciclib versus fulvestrant combined with dalpiciclib in patients with locally advanced/metastatic breast cancer who had developed drug resistance to prior adjuvant endocrine therapy.

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Key information

Conditions

Locally Advanced or Metastatic Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Chinese PLA General Hospital Fifth Medical Center

Beijing, Beijing Municipality, 100000, China

Location status: Recruiting

Location contact

Zefei Jiang

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 old;
  • Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0 to 1;
  • Patients with histologically confirmed locally advanced or metastatic breast cancer;
  • Patients with prior adjuvant endocrine resistance following curative-intent surgery;
  • Menstrual status: postmenopausal, perimenopausal, or premenopausal;
  • Presence of evaluable lesions;
  • Organ function must meet required criteria.

Exclusion criteria

  • Patients with rapidly progressing disease, as judged by the investigator to be unsuitable for endocrine therapy;
  • Patients who have previously received fulvestrant or other novel SERMs (excluding tamoxifen and toremifene);
  • Patients with uncontrolled brain metastases, carcinomatous meningitis, or spinal cord compression;
  • Patients with a history of clinically significant cardiovascular disease;
  • Participants who have not recovered from adverse effects caused by prior therapies;
  • Participants with a history of another malignancy within the past 5 years or currently having another malignancy;
  • Known hypersensitivity to HRS-8080, fulvestrant, dalpiciclib, or any of their components, etc.

Treatment and study plan

HRS-8080 Tablet ; Dalpiciclib Isethionate

Drug
  • HRS-8080 Tablet
  • Dalpiciclib Isethionate

Fulvestrant injection ;Dalpiciclib Isethionate

Drug
  • Fulvestrant injection
  • Dalpiciclib Isethionate

Primary outcomes

  1. Investigator assessed Progression free survival (PFS)

    Time frame: Up to 5 years.

    PFS is defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1), or death from any cause during the study.

Secondary outcomes

  1. Progression free survival (PFS) evaluated by the blinded independent central review (BICR)

    Time frame: Up to 5 years

  2. Overall response rate (ORR)

    Time frame: Up to 5 years

  3. Clinical benefit rate (CBR)

    Time frame: Up to 5 years

  4. Duration of response (DOR)

    Time frame: Up to 5 years

  5. Overall survival (OS)

    Time frame: Up to 8 years

  6. The incidence and severity of adverse events (AEs)

    Time frame: Up to 5 years

  7. The incidence and severity of serious adverse events (SAEs)

    Time frame: Up to 5 years

  8. Number of participants with vital sign abnormalities over the course of the study. Vital signs include respiratory rate, pulse rate, systolic and diastolic blood pressure, and temperature

    Time frame: Up to 5 years

  9. Number of participants with clinical laboratory test abnormalities for haematology and biochemistry parameters over the course of the study

    Time frame: Up to 5 years

  10. Heart rate (beats per minute) measured by 12-lead electrocardiography.

    Time frame: Up to 5 years

  11. QT interval (ms) measured by 12-lead electrocardiography.

    Time frame: Up to 5 years

    Eastern Cooperative Oncology Group (ECOG) performance status. ECOG performance status was measured on a 6 point grade scale.

    0: Fully active, able to carry on all pre-disease performance without restriction.

    • Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.
    • Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours.
    • Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.
    • Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.
    • Dead.

  12. Plasma concentrations of HRS-8080 and dalpiciclib isethionate

    Time frame: Up to approximately 2 years

Study contacts

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

Zhan Zhang

CONTACT

[email protected]

+86 17721286165

Sponsors and collaborators

Lead sponsor

Shandong Suncadia Medicine Co., Ltd.

Industry

Registry information

Official study title

A Multicenter, Open-label, Randomized Controlled Phase III Clinical Study Evaluating the Efficacy and Safety of HRS-8080 Combined With Dalpiciclib Versus Fulvestrant Combined With Dalpiciclib in Patients With Locally Advanced or Metastatic Breast Cancer Resistant to Adjuvant Endocrine Therapy.

Important dates

Study start
2026
Primary completion
2028
Study completion
2031
First posted
Jan 21, 2026
Registry last updated
Jun 2, 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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