A Randomized, Controlled, Open-label Clinical Trial of Adjuvant Intensive Therapy for HR+/ HER2-SNF4 Early Breast Cancer

Conditions

• HR+/HER2-breast Cancer

Eligibility Criteria

Sex

FEMALE

Age

18 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

• Standard endocrine therapy plus Apatinib — DRUG
  Standard endocrine therapy plus Apatinib

Study Details

This is a randomized, controlled, open, phase III trial of adjuvant intensive therapy for early breast cancer with HR+/ HER2-SNF4 based on SNF molecular typing. A randomized, controlled, open Phase III study to explore the efficacy and safety of Apatinib combined with standard endocrine therapy in adjuvant intensive therapy for HR+/ HER2-SNF4 type early high-risk breast cancer.

Key Dates

Start date

Jun 1, 2023

Status verified

Jun 2023

Primary completion

Jun 1, 2026

Completion

Jun 1, 2026

Study Design

Enrollment

916 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Standard endocrine therapy plus Apatinib
  5 to 10 years of endocrine therapy (e.g., aromatase inhibitors, tamoxifen, LHRH agonists, etc.) and 2 years of CDK4/6 inhibitors, depending on clinical indications. plus Apatinib, 250mg orally once a day;
• Active Comparator: Standard endocrine therapy
  5 to 10 years of endocrine therapy (e.g., aromatase inhibitors, tamoxifen, LHRH agonists, etc.) and 2 years of CDK4/6 inhibitors, depending on clinical indications.

Primary Outcome Measure

3-year survival without invasive disease (iDFS) [ Time Frame: 3 years ]