Recruiting NCT06447623
Apatinib Combined With cdk4/6i in First-line Treatment for HR+/HER2- SNF4 Subtype Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Apatinib, CDK4/6 Inhibitor, Aromatase inhibitor and Fulvestrant.
- Who it may be relevant to
- Registry conditions: Advanced Breast Cancer, HR+/HER2- Breast Cancer. Basic parameters: 18 years — 75 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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)
Overview
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.
Interventions
- Drug Apatinib
Apatinib is a kind of TKI inhibitor. - Drug CDK4/6 Inhibitor
Dalpiciclib (SHR6390) is a kind of CDK4/6 inhibitor that has demonstrated tolerability and preliminary clinical activity in patients with heavily pretreated hormone receptor-positive, HER2-negative advanced breast cancer. - Drug Aromatase inhibitor and Fulvestrant
Endocrine therapy combined with CDK4/6 inhibitors is the standard first-line therapy for advanced luminal breast cancer. Investigators choose endocrine therapy including Letrozole, Anastrozole, Exemestane, and Fulvestrant. Postmenopausal participants should use Goserelin.
Primary outcome measures
- Progression Free Survival (PFS) [Time frame: Approximately 5 years]
Secondary outcome measures (4)
- Clinical Benefit Rate (CBR) [Time frame: Approximately 5 years]
- Objective Response Rate (ORR) [Time frame: Approximately 5 years]
- Overall Survival (OS) [Time frame: Approximately 5 years]
- Safety and tolerability [Time frame: Approximately 5 years]
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:
- Blood routine examination standards should meet: HB≥90g/L (no blood transfusion within 14 days); ANC≥1.5×109/L; PLT≥75×109/L;
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Fudan University Shanghai Cancer Center — Shanghai
Identifiers
NCT: NCT06447623 · SCHBCC-N068