OncoMatch/Clinical Trials/NCT07065435
RC48 Plus Bevacizumab or Pyrotinib in HER2-Positive Metastatic Breast Cancer After T-DXd Failure: A Phase II Study
Is NCT07065435 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Disitamab Vedotin (RC48) and Bevacizumab for her2 + breast cancer.
Treatment: Disitamab Vedotin (RC48) · Bevacizumab · Pyrotinib — This multicenter, Phase II study (RADIANT-BC01) evaluates the efficacy and safety of Disitamab Vedotin (RC48) in combination with either bevacizumab or pyrotinib in adult patients with HER2-positive metastatic breast cancer whose disease has progressed on prior trastuzumab deruxtecan (T-Dxd) therapy. Eligible participants will be randomized 1:1 to receive RC48 plus bevacizumab (7.5 mg/kg IV every 2 weeks) or RC48 plus pyrotinib (320 mg orally once daily). Treatment continues until disease progression, unacceptable toxicity, withdrawal of consent, or initiation of new anticancer therapy. The primary endpoint is objective response rate (ORR); key secondary endpoints include progression-free survival (PFS), disease control rate (DCR), duration of response (DOR), overall survival (OS), and safety. This study aims to identify new post-T-Dxd treatment options and improve outcomes for patients with advanced HER2-positive breast cancer.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) overexpression (ihc 3+ or ihc 2+ with ish amplification)
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: antibody-drug conjugate (trastuzumab deruxtecan)
Cannot have received: antibody-drug conjugate (disitamab vedotin)
Lab requirements
Blood counts
absolute neutrophil count ≥1.5 × 10⁹/l; platelet count ≥100 × 10⁹/l; hemoglobin ≥9 g/dl
Kidney function
creatinine clearance ≥50 ml/min
Liver function
alt and ast ≤2.5 × uln; total bilirubin ≤1.5 × uln
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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