NCT07382687
Not yet recruiting
Phase 3
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
Overview
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Fudan University
- Enrollment
- 248
- Locations
- 1
- Primary Endpoint
- Progression Free Survival(PFS) Based on Investigator Assessment
Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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;
- •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;
- •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;
- •Subjects voluntarily join this study, sign the informed consent form, have good compliance and cooperate with follow-up
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);
- •Significant comorbidities, including mental illnesses that the investigator believes may adversely affect the patient's participation in the study;
- •Patients with a history of gastrointestinal bleeding within the past 6 months or a clear tendency for gastrointestinal bleeding, such as esophageal varices with bleeding risk, localized active ulcer lesions, and occult blood in stool ≥ (++), are not eligible for enrollment; if occult blood in stool is (+), gastroscopy is required;
Arms & Interventions
Control
Active Comparator
SHR-A1811
Intervention: SHR-A1811 (Drug)
Experimental
Experimental
Famitinib+SHR-A1811
Intervention: Famitinib+SHR-A1811 (Drug)
Outcomes
Primary Outcomes
Progression Free Survival(PFS) Based on Investigator Assessment
Time Frame: 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
Secondary Outcomes
- Overall survival (OS)(From the date of randomization up to the date of death due to any cause, up to approximately 3 years)
- Objective response rate (ORR)(From screening and every 6 weeks up to withdrawal of subject consent, progressive disease (PD), or unacceptable toxicity, up to approximately 3 years)
- Clinical benefit rate(CBR)(From screening and every 6 weeks up to withdrawal of subject consent, progressive disease (PD), or unacceptable toxicity, up to approximately 3 years)
- Duration of Response(DOR)(From the date of the first documented objective response (CR or PR) to the first documented disease progression or death, whichever occurs first, up to approximately 3 years)
- Time to Response(TTR)(from randomization to the achievement of first objective response, up to approximately 3 years)
- Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events(TESAEs)(From first dose of study drug (Day 1) up to approximately 3 years)
Investigators
Zhimin Shao
Director of General Surgery of Fudan Shanghai Cancer Center
Fudan University
Study Sites (1)
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