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

Sponsor
Fudan University
Study ID
NCT06447623
Phase
PHASE3
Status
Recruiting
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Conditions

  • Advanced Breast Cancer
  • HR+/HER2- Breast Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Apatinib — DRUG
    Apatinib is a kind of TKI inhibitor.
  • CDK4/6 Inhibitor — DRUG
    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.
  • Aromatase inhibitor and Fulvestrant — DRUG
    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.

Study Details

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.

Key Dates

Start date
Feb 1, 2024
Status verified
Jun 2024
Primary completion
Feb 1, 2027
Completion
Feb 1, 2029

Study Design

Enrollment
184 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm-A
    Apatinib combined with cdk4/6i and Endocrine therapy.
  • Active Comparator: Arm-B
    cdk4/6i and Endocrine therapy.

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: Approximately 5 years ]

Central Contacts

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