Apatinib Combined With cdk4/6i in First-line Treatment for HR+/HER2- SNF4 Subtype Breast Cancer

Trial Title: Apatinib Combined With cdk4/6i in First-line Treatment for HR+/HER2- SNF4 Subtype Breast Cancer

NCT ID: NCT06447623

Condition: Advanced Breast Cancer
HR+/HER2- Breast Cancer

Conditions: Official terms:
Breast Neoplasms
Apatinib
Fulvestrant
Aromatase Inhibitors

Conditions: Keywords:
HR+/HER2- breast cancer
Advanced Breast Cancer

Study type: Interventional

Study phase: Phase 3

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Apatinib
Description: Apatinib is a kind of TKI inhibitor.
Arm group label: Arm-A

Intervention type: Drug
Intervention name: CDK4/6 Inhibitor
Description: 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.
Arm group label: Arm-A
Arm group label: Arm-B

Intervention type: Drug
Intervention name: Aromatase inhibitor and Fulvestrant
Description: 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.
Arm group label: Arm-A
Arm group label: Arm-B

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.

Criteria for 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.

Gender: Female

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Fudan University Shanghai Cancer Center

Address:
City: Shanghai
Zip: 200032
Country: China

Status: Recruiting

Contact:
Last name: Zhimin Shao Shao, MD, PhD

Phone: 86-021-64175590

Phone ext: 88807
Email: zhimingshao@yahoo.com

Contact backup:
Last name: Peng Ji, MD

Phone: 86-021-64175590

Phone ext: 62978
Email: JIPENG_1010@163.COM

Start date: February 1, 2024

Completion date: February 1, 2029

Lead sponsor:
Agency: Fudan University
Agency class: Other

Source: Fudan University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06447623