OncoMatch/Clinical Trials/NCT06642545
Efficacy and Safety Study of Disitamab Vedotin + RC148 vs. Albumin-Paclitaxone ± Toripalimab in HR-/HER2-low Breast Cancer
Is NCT06642545 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Disitamab Vedotin and RC148 for breast cancer.
Treatment: Disitamab Vedotin · RC148 · Albumin-bound Paclitaxone · Toripalimab — Evaluating the Efficacy of Disitamab Vedotin in Combination with RC148 Compared to Albumin-bound Paclitaxone Monotherapy or in Combination with Toripalimab for Subjects with HR-negative, HER2-low Expressing Unresectable Locally Advanced or Metastatic Breast Cancer
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) low expression (HER2 low expression by central laboratory)
Invasive breast tumor tissue has been confirmed as HER2 low expression by the central laboratory
Required: ESR1 negative (IHC <1% positive nuclear staining)
Invasive tumor tissue is negative for hormone receptors (HR), defined as immunohistochemistry (IHC) testing showing that the proportion of cells with positive nuclear staining for both ER and PgR in invasive cancer is less than 1%.
Required: PR (PGR) negative (IHC <1% positive nuclear staining)
Invasive tumor tissue is negative for hormone receptors (HR), defined as immunohistochemistry (IHC) testing showing that the proportion of cells with positive nuclear staining for both ER and PgR in invasive cancer is less than 1%.
Disease stage
Required: Stage III, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: HER2-targeted therapy
Having previously received anti-HER2 treatment, including ADC (Antibody-Drug Conjugates).
Cannot have received: antibody-drug conjugate
Having previously received anti-HER2 treatment, including ADC (Antibody-Drug Conjugates).
Cannot have received: immunotherapy (anti PD-(L)1, anti PD-(L)2, CD137, CTLA-4, OX-40)
Exception: except if the last administration was ≥12 months prior to recurrence or progression, using [neo]adjuvant anti PD-(L)1
Having previously received immunotherapy, including anti PD-(L)1 or anti PD-(L)2 drugs, or drugs that directly target another stimulatory or co-inhibitory T-cell receptor (such as CD137, CTLA-4, OX-40) during the locally advanced or metastatic stage (except if the last administration was ≥12 months prior to recurrence or progression, using [neo]adjuvant anti PD-(L)1).
Lab requirements
Blood counts
Hemoglobin ≥ 90 g/L; Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L; Platelet count ≥ 100 × 10^9/L
Kidney function
Creatinine clearance (CrCl) calculated by the Cockcroft-Gault formula ≥ 40 mL/min, or serum creatinine ≤ 1.5 × ULN; Urine protein < 2+; if urine protein ≥ 2+, the 24-hour urine protein quantification result must be < 1 g.
Liver function
Total bilirubin ≤ 1.5 × ULN or direct bilirubin ≤ ULN (for subjects with total bilirubin > 1.5 × ULN). Total bilirubin ≤ 3 × ULN (for subjects with Gilbert's disease); AST and ALT ≤ 2.5 × ULN or ≤ 5 × ULN (if liver metastases are present)
Hematologic and organ function criteria to be met within 7 days prior to the first dose of study medication (with normal values based on the clinical trial center's standards, and no blood transfusions, hematopoietic growth factors, albumin, or blood products within 14 days prior to the test): Hemoglobin ≥ 90 g/L Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L Platelet count ≥ 100 × 10^9/L Total bilirubin ≤ 1.5 × upper limit of normal (ULN) or direct bilirubin ≤ ULN (for subjects with total bilirubin > 1.5 × ULN). Total bilirubin ≤ 3 × ULN (for subjects with Gilbert's disease) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN or ≤ 5 × ULN (if liver metastases are present) International normalized ratio (INR), prothrombin time (PT), and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN Creatinine clearance (CrCl) calculated by the Cockcroft-Gault formula ≥ 40 mL/min, or serum creatinine ≤ 1.5 × ULN Urine routine test shows urine protein < 2+; if urine protein ≥ 2+, the 24-hour urine protein quantification result must be < 1 g.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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