Apatinib With CDK4/6 Inhibitor and Endocrine Therapy in HR+/ HER2- Advanced Breast Cancer

Sponsor
Fudan University
Study ID
NCT05759572
Phase
PHASE2
Status
Recruiting
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Conditions

  • Breast Cancer Metastatic

Eligibility Criteria

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

Interventions

  • Apatinib — DRUG
    TKI
  • Dalpiciclib — DRUG
    CDK4/6 inhibitor
  • Fulvestrant/AI — DRUG
    Endocrine therapy

Study Details

This study is a prospective, open-label, phase II clinical study for patients with HR+/HER2- advanced breast cancer.

Key Dates

Start date
Feb 1, 2023
Status verified
Feb 2023
Primary completion
Nov 1, 2025
Completion
Jun 1, 2027

Study Design

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

Arms

  • Experimental: Cohort 1
    In this cohort, a patient would receive Dalpiciclib(CDK4/6 inhibitor) combined with Apatinib and endocrine therapy.
  • Active Comparator: Cohort 2
    In this cohort, a patient would receive Dalpiciclib(CDK4/6 inhibitor) combined with endocrine therapy.

Primary Outcome Measure

PFS [ Time Frame: Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the end of study (approximately 5 years) ]

Central Contacts

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