A Multicenter Clinical Study of Apatinib Mesylate Combined With Doctor's Choice for Advanced Breast Cancer

Sponsor
Li Huiping
Study ID
NCT06339281
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Advanced Breast Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • apatinib mesylate+Capecitabine Tablets — DRUG
    Apatinib Mesylate Tablets: 500 mg, qd, orally until disease progression or intolerable adverse reactions. Capecitabine Tablets: 1000 mg/m2, po, twice a day, d1-d14, discontinued for 1 week after 2 weeks of treatment;
  • apatinib mesylate+Fulvestrant injection — DRUG
    Apatinib Mesylate Tablets: 500 mg, qd, orally until disease progression or intolerable adverse reactions. Fulvestrant injection 500 mg, intramuscular injection, q4w, once on d1 and d15 in the first cycle;

Study Details

Previous studies have found good efficacy of (investigator's choice of chemotherapy, or endocrine drug) in combination with apatinib mesylate in the treatment of her-2 negative, chest wall metastatic advanced breast cancer, and the present study proposes to further explore the efficacy of apatinib mesylate in her-2 negative, HR-positive advanced breast cancer.

Key Dates

Start date
May 1, 2024
Status verified
Apr 2024
Primary completion
Jun 30, 2026
Completion
Dec 31, 2026

Study Design

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

Arms

  • Experimental: Apatinib mesylate combined with chemotherapy (Capecitabine/vinorelbine)
  • Active Comparator: Apatinib mesylate combined with endocrine

Primary Outcome Measure

Progression-free survival [ Time Frame: 36 months ]

Central Contacts

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