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Famitinib Combined With SHR-A1811, Versus SHR-A1811 for CDK4/6 Inhibitors-resistent Advanced HR+/HER2- Breast Cancer With SNF4 Subtype

A Phase 3, Multicenter, Randomized, Open-label, Active-controlled Trial of Famitinib Combined With SHR-A1811, Versus SHR-A1811 for CDK4/6 Inhibitors-resistent Advanced HR+/HER2- Breast Cancer With SNF4 Subtype

NCT07382687•Fudan University

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 70 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•1. Women aged 18-70 years old;
•2. 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 \[FISH/CISH- and IHC+/++ or IHC 0 but with ≤10% of tumor cells showing incomplete and weak cell membrane staining\]);
•3. SNF4 subtype definition: SNF4 subtype confirmed by digital pathology of H\&E sections and artificial intelligence;
•4. Locally advanced breast cancer (unresectable locally) or recurrent and metastatic breast cancer;
•5. 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;
•6. 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;
•7. 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;
•8. ECOG score ≤2, and expected survival ≥3 months;
•9. Female subjects who are capable of bearing children need to adopt a medically approved contraceptive measure during the study treatment period and for at least 3 months after the last use of study medication;
•10. Subjects voluntarily join this study, sign the informed consent form, have good compliance and cooperate with follow-up

Exclusion Criteria

•1. Uncontrolled central nervous system metastasis (referring to symptoms or the need for corticosteroids or mannitol to control symptoms);
•2. Left ventricular ejection fraction (LVEF) \<50% (as determined by echocardiography);
•3. 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;
•4. 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;
•5. 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;
•6. 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;
•7. Pregnant or lactating patients;
•8. 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);
•9. Significant comorbidities, including mental illnesses that the investigator believes may adversely affect the patient's participation in the study;
•11. Patients who have experienced abdominal fistula, gastrointestinal perforation, or abdominal abscess within 28 days before participating in this study;
+9 more criteria

Locations (1)

Breast cancer institute of Fudan University Cancer Hospital

Shanghai, China

Key Dates

Start Date

February 26, 2026

Primary Completion Date

December 31, 2028

Completion Date

December 31, 2029

Last Updated

February 3, 2026

Enrollment

248

ESTIMATED participants

Conditions

Breast Cancer

Interventions

SHR-A1811

DRUG

Famitinib+SHR-A1811

DRUG

Contacts

Zhimin Shao

CONTACT

+8808 +86-021-64175590 zhimingshao@yahoo.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 3, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Famitinib Combined With SHR-A1811, Versus SHR-A1811 for CDK4/6 Inhibitors-resistent Advanced HR+/HER2- Breast Cancer With SNF4 Subtype

Inclusion Criteria

Exclusion Criteria

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