NCT06339281

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

A Multicenter Clinical Study of Apatinib Mesylate in Combination With a Physician's Choice Regimen for Her-2 Negative, HR-positive Progressive Breast Cancer.

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: Li Huiping · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

In order to further explore the efficacy of apatinib mesylate in advanced breast cancer with negative her-2 and positive HR, this study intends to carry out an observation study on the efficacy of apatinib mesylate combined with doctor's choice scheme in the treatment of advanced breast cancer with negative her-2 and positive HR.

Conditions

• Advanced Breast Cancer

Interventions

Type	Name	Description
DRUG	apatinib mesylate+Capecitabine Tablets	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;
DRUG	apatinib mesylate+Fulvestrant injection	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;

Timeline

• Start date: 2024-05-01
• Primary completion: 2026-06-01
• Completion: 2026-12-01
• First posted: 2024-04-01
• Last updated: 2024-04-19