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Clinical Trials in China / NCT06957379
Active, not recruiting Phase 2

Sirolimus for Injection (Albumin-bound) in Combination With Endocrine Therapy for HR+/HER2- Advanced/Metastatic Breast Cancer Patients Who Have Failed Standard Therapy

NCT06957379 · tracked via the Priya Life Science China tracker
Sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Phase
Phase 2
Started
2024-02-29
Last updated
2025-05-04

Condition(s) studied

HR+/HER2- Advanced/Metastatic Breast Cancer

Investigational drug(s) / intervention(s)

LetrozoleAnastrozoleExemestaneFulvestrantSirolimus for Injection (Albumin-bound)

Letrozole: Oral administration at a dose of 2.5 mg once daily for a 4-week cycle

Anastrozole: Oral administration at a dose of 1 mg once daily for a 4-week cycle

Exemestane: Oral administration at a dose of 25 mg once daily with a meal every 4 weeks

Fulvestrant: Fulvestrant: IM injection, 500 mg, on day 1 and day 15 of Cycle 1, and then on day 1 of each cycle thereafter, 4 weeks per treatment cycle

Sirolimus for Injection (Albumin-bound): IV infusion, every 2 weeks, 4 weeks per treatment cycle

Study summary

This study is a multicenter, open, non-randomized phase II clinical trial consisting of a safety introduction phase followed by a single-arm phase 2 phase. This phase II trial enrolled patients with HR+/HER2- advanced breast cancer who had failed aromatase inhibitor (AI)/fulvestrant ± CDK4/6i. Pts failing prior AI ± CDK4/6i received nab-Sirolimus + fulvestrant, while those failing fulvestrant ± CDK4/6i received nab-Sirolimus + AI.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * 1\. Aged 18 or above, regardless of gender; female patients must be postmenopausal, or premenopausal/perimenopausal. * 2\. Pathologically confirmed HR+, HER2- breast cancer. * 3\. Patients who have failed prior treatment with AI or fulvestrant with or without CDK4/6 inhibitors. * 4\. No more than 3 lines of chemotherapy for inoperable locally advanced or metastatic disease. * 5\. At least one measurable lesion according to RECIST 1.1 criteria. Patients with bone lesions only may be eligible. * 6\. ECOG performance status score of 0-1. * 7\. Investigator-assessed life expectancy ≥3 months. * 8\. Adequate organ and bone marrow function. * 9\. Baseline fasting serum triglyceride \<300mg/dL or 3.42mmol/L, fasting serum cholesterol \<350mg/dL or 9.07mmol/L * 10\. The baseline fasting plasma glucose (FPG) ˂ 7.8 mmol/L and glycosylated hemoglobin (HbA1c) ˂ 8% * 11\. 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 6 months after stopping study treatment; female patients of childbearing potential must have a negative pregnancy test before starting study treatment and must not be breastfeeding. * 12\. Male patients must agree to use barrier contraception (i.e., condoms) during the study and for 6 months after stopping study treatment; for men with future fertility plans, sperm freezing is recommended before starting study treatment. * 13\. Participants must provide informed consent before the trial and voluntarily sign the written ICF. Exclusion Criteria: * 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. * 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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Cancer Hospital, Chinese Academy of Medical Sciences Beijing Beijing Municipality

More CSPC ZhongQi Pharmaceutical Technology Co., Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06957379 on ClinicalTrials.gov ↗ ← All trials in China