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.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HRS-8080 Tablet ; Dalpiciclib Isethionate, Fulvestrant injection ;Dalpiciclib Isethionate.
- Who it may be relevant to
- Registry conditions: Locally Advanced or Metastatic Breast Cancer. Basic parameters: 18 years — 75 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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.
Overview
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
- Drug HRS-8080 Tablet ; Dalpiciclib Isethionate
* HRS-8080 Tablet * Dalpiciclib Isethionate - Drug Fulvestrant injection ;Dalpiciclib Isethionate
* Fulvestrant injection * Dalpiciclib Isethionate
Primary outcome measures
- Investigator assessed Progression free survival (PFS) [Time frame: Up to 5 years.]
Secondary outcome measures (12)
- Progression free survival (PFS) evaluated by the blinded independent central review (BICR) [Time frame: Up to 5 years]
- Overall response rate (ORR) [Time frame: Up to 5 years]
- Clinical benefit rate (CBR) [Time frame: Up to 5 years]
- Duration of response (DOR) [Time frame: Up to 5 years]
- Overall survival (OS) [Time frame: Up to 8 years]
- The incidence and severity of adverse events (AEs) [Time frame: Up to 5 years]
- The incidence and severity of serious adverse events (SAEs) [Time frame: 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 [Time frame: Up to 5 years]
- 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]
- Heart rate (beats per minute) measured by 12-lead electrocardiography. [Time frame: Up to 5 years]
- QT interval (ms) measured by 12-lead electrocardiography. [Time frame: Up to 5 years]
- Plasma concentrations of HRS-8080 and dalpiciclib isethionate [Time frame: Up to approximately 2 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Chinese PLA General Hospital Fifth Medical Center — Beijing
Identifiers
NCT: NCT07354022 · HRS-8080-301