Life sciences · Phase 2 Trial
ClinicalTrials.gov · October 30, 2026
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Phase 2 Trial.
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Registry record from ClinicalTrials.gov (NCT07907354). This is a study registration, not published results. Lead sponsor: Yunnan Cancer Hospital. Recruitment status: NOT_YET_RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 56 participants (ESTIMATED). Conditions: Breast Neoplasms, Advanced Breast Cancer, HER2-positive Breast Cancer, HER2-low Breast Cancer. Interventions: DRUG: Apatinib mesylate; DRUG: Physician's choice chemotherapy. Primary outcome measures: Objective Response Rate (ORR) , every 2 cycles (each cycle is 21 or 28 days depending on chosen chemotherapy), up to disease progression or 24 months. Brief summary: This is a single-arm, open-label, phase 2 clinical trial using a stratified Simon minimax two-stage design. The study aims to evaluate the efficacy and safety of low-dose apatinib (250 mg daily) combined with physician-selected single-agent chemotherapy (TPC, capecitabine preferred) in patients with HER2-positive or HER2-low advanced/metastatic breast cancer who progressed after prior ADC therapy (T-DXd or SHR-A1811). Patients are stratified by HER2 status, HR status, lines of prior ADC therapy, and metastasis sites. Approximately 56 patients will be enrolled. The primary endpoint is objective response rate (ORR). Secondary endpoints include PFS1, PFS2, TTP, safety, and OS.