Clinical trial NCT06447623: Apatinib Combined With cdk4/6i in First-line Treatment for HR+/HER2- SNF4 Subtype Breast Cancer
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Advanced Breast Cancer
HR+/HER2- Breast Cancer
Keywords: HR+/HER2- breast cancer
Advanced Breast Cancer
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2024-06-07
Enrollment: 184
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 \&gt;10%, or/and PR\&gt;10%, HER 0 OR +, if HER2++, FISH negative);
  * SNF4 subtype definition: SNF4 subtype confirmed by digital pathology of H\&amp;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 \&gt; 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\&#39;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.

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: Approximately 5 years
Secondary outcomes:
measure: Clinical Benefit Rate (CBR)
timeFrame: Approximately 5 years
measure: Objective Response Rate (ORR)
timeFrame: Approximately 5 years
measure: Overall Survival (OS)
timeFrame: Approximately 5 years
measure: Safety and tolerability
timeFrame: Approximately 5 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
References: