Status:
NOT_YET_RECRUITING
Sirolimus for Injection (Albumin-bound) Combined With Fulvestrant for HR+/HER2- Advanced/Metastatic Breast Cancer Patients Previously Treated With CDK4/6 Inhibitors
Lead Sponsor:
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Conditions:
HR+/HER2- Advanced/Metastatic Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
A randomized, double-blind, multicenter phase III clinical study to evaluate the efficacy and safety of sirolimus for injection (albumin-bound) combined with fulvestrant in patients with HR+ and HER2-...
Eligibility Criteria
Inclusion
- 1\. Aged 18 or above, regardless of gender; female patients must be postmenopausal, or premenopausal/perimenopausal.
- 2\. Pathologically confirmed HR+, HER2- breast cancer.
- 3\. Locally advanced or metastatic breast cancer, not suitable for curative surgery or radiotherapy, and no current clinical indication for chemotherapy.
- 4\. Previously received at least one, up to two lines of systemic therapy (including at least one line of endocrine therapy combined with CDK4/6 inhibitor therapy).
- 5\. At least one measurable lesion according to RECIST 1.1 criteria.
- 6\. Willing to provide tumor and/or blood samples for biomarker testing; if unable to provide, subject to investigator and sponsor evaluation for eligibility.
- 7\. ECOG performance status score of 0-1.
- 8\. Investigator-assessed life expectancy ≥6 months.
- 9\. Adequate organ and bone marrow function.
- 10\. Premenopausal female patients using LHRH agonists to suppress ovarian function must agree to use two acceptable forms of highly effective contraception during the study and for 2 years after stopping study treatment; female patients of childbearing potential must have a negative pregnancy blood test before starting study treatment and must not be breastfeeding.
- 11\. Male patients must agree to use barrier contraception (i.e., condoms) during the study and for 2 years after stopping study treatment; for men with future fertility plans, sperm freezing is recommended before starting study treatment.
- 12\. Participants must provide informed consent before the trial and voluntarily sign the written ICF.
Exclusion
- 1\. Previous pathological diagnosis of HER2-positive breast cancer.
- 2\. Patients judged by the investigator to be unsuitable for endocrine therapy.
- 3\. Patients who have previously received PI3K/AKT/mTOR inhibitors, fulvestrant, or other ER-targeted therapies (including oral SERDs, ER protein degraders PROTAC, etc.).
- 4\. Received chemotherapy, radiotherapy, biological therapy, targeted therapy, immunotherapy, or other anti-tumor treatments within 4 weeks before randomization.
- 5\. Received other unapproved investigational drugs within 4 weeks before randomization.
- 6\. Underwent major surgery within 4 weeks before randomization or has not fully recovered from any previous invasive procedures.
- 7\. Received systemic glucocorticoids (prednisone \>10 mg/day or equivalent) or other immunosuppressive treatments within 2 weeks before randomization.
- 8\. Had an infection within 2 weeks before randomization requiring systemic (oral or IV) anti-infective treatment (uncomplicated urinary tract infections or upper respiratory tract infections excluded).
- 9\. Received inactivated or live attenuated vaccines or COVID-19 vaccines within 4 weeks before randomization.
- 10\. Used strong inhibitors or inducers of CYP3A4 hepatic metabolic enzymes within 2 weeks before randomization or still need to continue using such drugs.
- 11\. Diagnosed with other malignancies within 5 years before randomization.
- 12\. Suffering from severe cardiovascular or cerebrovascular diseases.
- 13\. Adverse reactions from previous anti-tumor treatments have not recovered to CTCAE 5.0 grade ≤1.
- 14\. Active leptomeningeal disease or poorly controlled central nervous system metastases.
- 15\. Presence of pleural/abdominal effusion or pericardial effusion with clinical symptoms or requiring symptomatic treatment.
- 16\. Known bleeding tendency (constitution) or coagulation disorders.
- 17\. History of severe lung diseases such as interstitial lung disease and/or pneumonia, pulmonary hypertension, or radiation pneumonitis requiring glucocorticoid treatment.
- 18\. Known hypersensitivity or intolerance to any component of the study drug or its excipients, or LHRH agonists (if applicable).
- 19\. History of autoimmune diseases (except tuberous sclerosis), immunodeficiency diseases, including HIV-positive, or other acquired or congenital immunodeficiency diseases, or organ transplant history.
- 20\. Active HBV, HCV, syphilis, or tuberculosis infection.
- 21\. Other conditions judged by the investigator to be unsuitable for participation in this study.
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
312 Patients enrolled
Trial Details
Trial ID
NCT06929325
Start Date
April 1 2025
End Date
December 1 2027
Last Update
April 16 2025
Active Locations (1)
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1
Clinical Trials Information Group
Shijiazhuang, Hebei, China