Famitinib Combined With SHR-A1811, Versus SHR-A1811 for CDK4/6 Inhibitors-resistent Advanced HR+/… (NCT07382687) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Famitinib Combined With SHR-A1811, Versus SHR-A1811 for CDK4/6 Inhibitors-resistent Advanced HR+/HER2- Breast Cancer With SNF4 Subtype
China248 participantsStarted 2026-02-26
Plain-language summary
This study is a prospective, open-label, multicenter, randomized controlled Phase III clinical trial. This study aims to investigate the efficacy and safety of Famitinib combination with SHR-A1811 in CDK4/6 inhibitors-resistent advanced HR+/HER2- breast cancer with SNF4 subtype.
Who can participate
Age range
18 Years – 70 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Women aged 18-70 years old;
. Histologically confirmed HR+/HER2- invasive breast cancer (specific definition: ER \>10% of tumor cells positive by immunohistochemistry is defined as ER positive, PR \>10% of tumor cells positive by immunohistochemistry is defined as PR positive, ER and/or PR positive is defined as HR positive; HER2 low expression or ultra-low expression \[FISH/CISH- and IHC+/++ or IHC 0 but with ≤10% of tumor cells showing incomplete and weak cell membrane staining\]);
. SNF4 subtype definition: SNF4 subtype confirmed by digital pathology of H\&E sections and artificial intelligence;
. Locally advanced breast cancer (unresectable locally) or recurrent and metastatic breast cancer;
. Have used CDK4/6 inhibitors in the recurrent and metastatic stage, or have relapsed and metastasized within 1 year of adjuvant CDK4/6 inhibitor use;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Progression Free Survival(PFS) Based on Investigator Assessment
Timeframe: From the date of randomization to the earliest date of the first objective documentation of radiographic disease progression or death due to any cause, up to approximately 3 years
. At least one measurable lesion according to RECIST 1.1 criteria (≥20 mm by conventional CT scan, ≥10 mm by spiral CT scan, and the measurable lesion has not received radiotherapy), or in the absence of measurable lesions, have non-measurable osteolytic or mixed (osteolytic + osteoblastic) bone lesions;
. Basic normal major organ function, meeting the following conditions: (a) Blood routine examination standards need to meet: HB ≥90 g/L (no blood transfusion within 14 days); ANC ≥1.5×109/L; PLT ≥75×109/L;(b) Biochemical examination needs to meet the following standards: TBIL ≤1.5×ULN (upper limit of normal value); ALT and AST ≤3×ULN; if there is liver metastasis, ALT and AST ≤5×ULN; serum Cr ≤1.5×ULN, endogenous creatinine clearance rate \>50 ml/min (Cockcroft-Gault formula);(c) Electrocardiogram: Fridericia's corrected QT interval (QTcF) \< 450 ms for men and \< 470 ms for women;
. ECOG score ≤2, and expected survival ≥3 months;
Exclusion criteria
. Uncontrolled central nervous system metastasis (referring to symptoms or the need for corticosteroids or mannitol to control symptoms);
. Left ventricular ejection fraction (LVEF) \<50% (as determined by echocardiography);
. History of any of the following cardiac diseases: (1) angina pectoris; (2) clinically significant arrhythmia requiring medication; (3) myocardial infarction; (4) heart failure; (5) any other cardiac disease deemed unsuitable for participation in this trial by the investigator;
. previously suffered from clinically significant pulmonary diseases, including but not limited to interstitial pneumonia, pneumonia, pulmonary fibrosis, and radiation pneumonia (excluding radiation changes that do not require corrective treatment), or have been found to have suspected such diseases during screening period examinations;
. Individuals who have received radiotherapy, chemotherapy, surgical treatment (excluding minor outpatient surgeries such as placement of vascular access) or other targeted and immunotherapy treatments for advanced HR+/HER2- breast cancer within 3 weeks prior to the first administration of study drugs;
. Individuals who have ongoing ≥ Grade 1 adverse reactions due to previous treatments. Exceptions to this include hair loss or conditions that the investigator deems should not be excluded. Such cases should be clearly documented in the investigator's notes;
. Pregnant or lactating patients;
. Individuals who have had malignant tumors within the past three years (excluding cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);