Locally Advanced or Metastatic Breast Cancer
Conditions
Brief summary
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.
Interventions
DRUGHRS-8080 Tablet ; Dalpiciclib Isethionate
* HRS-8080 Tablet * Dalpiciclib Isethionate
DRUGFulvestrant injection ;Dalpiciclib Isethionate
* Fulvestrant injection * Dalpiciclib Isethionate
Sponsors
Shandong Suncadia Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Women aged 18 - 75 years old; 2. Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0 to 1; 3. Patients with histologically confirmed locally advanced or metastatic breast cancer; 4. Patients with prior adjuvant endocrine resistance following curative-intent surgery; 5. Menstrual status: postmenopausal, perimenopausal, or premenopausal; 6. Presence of evaluable lesions; 7. Organ function must meet required criteria.
Exclusion criteria
1. Patients with rapidly progressing disease, as judged by the investigator to be unsuitable for endocrine therapy; 2. Patients who have previously received fulvestrant or other novel SERMs (excluding tamoxifen and toremifene); 3. Patients with uncontrolled brain metastases, carcinomatous meningitis, or spinal cord compression; 4. Patients with a history of clinically significant cardiovascular disease; 5. Participants who have not recovered from adverse effects caused by prior therapies; 6. Participants with a history of another malignancy within the past 5 years or currently having another malignancy; 7. Known hypersensitivity to HRS-8080, fulvestrant, dalpiciclib, or any of their components, etc.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Investigator assessed Progression free survival (PFS) | 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
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival (PFS) evaluated by the blinded independent central review (BICR) | Up to 5 years | — |
| Overall response rate (ORR) | Up to 5 years | — |
| Clinical benefit rate (CBR) | Up to 5 years | — |
| Duration of response (DOR) | Up to 5 years | — |
| Overall survival (OS) | Up to 8 years | — |
| The incidence and severity of adverse events (AEs) | Up to 5 years | — |
| The incidence and severity of serious adverse events (SAEs) | Up to 5 years | — |
| 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 | Up to 5 years | — |
| Number of participants with clinical laboratory test abnormalities for haematology and biochemistry parameters over the course of the study | Up to 5 years | — |
| Heart rate (beats per minute) measured by 12-lead electrocardiography. | Up to 5 years | — |
| QT interval (ms) measured by 12-lead electrocardiography. | 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. 1. 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. 2. Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours. 3. Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4. Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5. Dead. |
| Plasma concentrations of HRS-8080 and dalpiciclib isethionate | Up to approximately 2 years | — |
Countries
China
Contacts
CONTACTZhan Zhang
Outcome results
None listed