NCT06447623 Apatinib Combined With cdk4/6i in First-line Treatment for HR+/HER2- SNF4 Subtype Breast Cancer
| NCT ID | NCT06447623 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Fudan University |
| Condition | Advanced Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 184 participants |
| Start Date | 2024-02-01 |
| Primary Completion | 2027-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 184 participants in total. It began in 2024-02-01 with a primary completion date of 2027-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a randomized, controlled, open-label, phase III study to explore the efficacy and safety of Apatinib in combination with standard first-line endocrine therapy for the HR+/ HER2-SNF4 subtype of advanced breast cancer. The study was used to explore the efficacy of Apatinib in combination with standard endocrine therapy.
Eligibility Criteria
Inclusion Criteria: * Inclusion Criteria: * Patients need to meet all of the following conditions * Patients must be ≥18 and ≤ 75 years of age; * Pathologically confirmed breast cancer is HR+/HER2- breast cancer (IHC ER \>10%, or/and PR\>10%, HER 0 OR +, if HER2++, FISH negative); * SNF4 subtype definition: SNF4 subtype confirmed by digital pathology of H\&E sections; * Locally advanced breast cancer (radical local therapy is not possible) or metastatic breast cancer (without using adjuvant CDK4/6 inhibitors in the past, or one year after adjuvant CDK4/6 inhibitor therapy has ended); * No prior therapy (chemotherapy, targeted therapy, etc.) for advanced or metastatic breast cancer; * Patients with at least one measurable lesion that has not previously received radiation therapy and can be evaluated repeatedly according to RECIST 1.1; * The functions of the main organs are basically normal, and the following conditions are met: 1. Blood routine examination standards should meet: HB≥90g/L (no blood transfusion within 14 days); ANC≥1.5×109/L; PLT≥75×109/L; 2. Biochemical examination shall meet the following standards: TBIL≤1.5×ULN (upper limit of normal value); ALT and AST≤3 x ULN; In case of liver metastasis, ALT and AST≤5×ULN; Serum Cr ≤1.5×ULN, endogenous creatinine clearance \> 50ml/min (Cockcroft-Gault formula); * ECOG performance status 0 or 1; The expected survival is more than 3 months; * Fertile female is required to use a medically approved contraceptive during study treatment and for at least 3 months after the last use of the study drug; * Patients voluntarily join the study, sign the informed consent, have good compliance, and cooperate with follow-up. Exclusion Criteria: * Patients with any of the following conditions were excluded from the study * Patients with central nervous system metastasis out of control (symptoms need to use glucocorticoids or mannitol). * A history of clinically significant or uncontrolled heart disease, including congestive heart failure, angina pectoris, myocardial infarction within the last 6 months, or ventricular arrhythmia; * Radiotherapy, chemotherapy, surgery, other targeted therapy, and immunotherapy for advanced HR+/HER2- breast cancer within 4 weeks before the first administration of drugs used in this study. * Pregnant or lactating patients; * Other malignancies within the previous 3 years, excluding cured skin basal cell carcinoma and cervical carcinoma in situ; * Significant comorbid medical conditions, including mental illnesses that the investigator or sponsor believes would adversely affect the patient\'s participation in the study; * Allergic physique, or known allergic history of the drug components of this program; Or allergic to other monoclonal antibodies; * The investigator does not consider the patient suitable for participation in any other circumstances of the study.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06447623 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 75 Years, studying Advanced Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06447623 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 184 participants.
Is NCT06447623 currently recruiting?
Yes, NCT06447623 is actively recruiting participants. Contact the research team at zhimingshao@yahoo.com for enrollment information.
Where is the NCT06447623 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06447623 clinical trial?
NCT06447623 is sponsored by Fudan University. The trial plans to enroll 184 participants.
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