Clinical trial · Interventional
Apatinib Combined With cdk4/6i in First-line Treatment for HR+/HER2- SNF4 Subtype Breast Cancer
Study of Efficacy of Apatinib Combined With cdk4/6i in First-line Treatment for HR+/HER2- SNF4 Subtype Advanced Breast Cancer (Open, Randomized, Phase III)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| HR+/HER2- Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Apatinib | Drug | — | UNRESOLVED |
| Aromatase inhibitor and Fulvestrant | Drug | — | UNRESOLVED |
| CDK4/6 Inhibitor | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm-A
- description
- Apatinib combined with cdk4/6i and Endocrine therapy.
- interventionNames
- Drug: Apatinib
- Drug: CDK4/6 Inhibitor
- Drug: Aromatase inhibitor and Fulvestrant
- type
- ACTIVE_COMPARATOR
- label
- Arm-B
- description
- cdk4/6i and Endocrine therapy.
- interventionNames
- Drug: CDK4/6 Inhibitor
- Drug: Aromatase inhibitor and Fulvestrant
Primary outcomes (1)
- measure
- Progression Free Survival (PFS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.References
Publications (0)
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