OncoMatch/Clinical Trials/NCT05904964
Disitamab Vedotin (RC48) in Hormone Receptor Positive, HER2-low Metastatic Breast Cancer (the Rosy Trial)
Is NCT05904964 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies Disitamab vedotin for hr positive/her2 low expression metastatic breast cancer.
Treatment: Disitamab vedotin — Hormone receptor positive, HER2-low expression metastatic breast cancer is the main type of breast cancer, accounting for about 50% - 60%. However, this type of patients lack ideal therapeutic drugs after the failure of first-line standard endocrine therapy, and the median overall survival time is only 30 months. Therefore, finding more efficient and safe therapeutic drugs for these patients has become a big clinical challenge at present. Disitamab Vedotin (DV), as a new class I Antibody-Drug Conjugates drug, can achieve high efficiency and precise tumor killing effect with low toxicity. According to previous study with same sample size, DV also showed good efficacy in metastatic breast cancer with Hormone receptor positive and HER2- low expression as a posterior line treatment.Therefore, we intend to explore the efficacy and safety of DV in the treatment of HER2-low expressioin /Hormone receptor positive metastatic breast cancer patients with endocrine resistance through a scientifically designed, randomized, phase III clinical study.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 overexpression (IHC ≥ 10%)
ER expression: immunohistochemical staining of tumor cells ≥ 10%
Required: PR (PGR) overexpression (IHC ≥ 10%)
PR expression: immunohistochemical staining of tumor cells ≥ 10%
Required: HER2 (ERBB2) low expression (IHC 2+ and FISH not amplified, or IHC 1+)
HER2-low: immunohistochemical staining of 2 + and FISH is not expanded, IHC 1 +
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: endocrine therapy
Patients who have received endocrine therapy
Cannot have received: chemotherapy
Exception: within 2 weeks before enrollment
Patients who had received chemotherapy ... within 2 weeks before enrollment
Cannot have received: radiotherapy
Exception: within 2 weeks before enrollment
Patients who had received ... radiotherapy ... within 2 weeks before enrollment
Cannot have received: immunotherapy
Exception: within 2 weeks before enrollment
Patients who had received ... immunotherapy ... within 2 weeks before enrollment
Cannot have received: endocrine therapy
Exception: within 2 weeks before enrollment
Patients who had received ... endocrine therapy ... within 2 weeks before enrollment
Lab requirements
Blood counts
WBC ≥ 3.0 × 10^9/L; ANC ≥ 1.5 × 10^9/L; PLT ≥ 70 × 10^9/L
Kidney function
serum creatinine ≤ 1.5 × ULN or creatinine clearance rate (CCR) ≥ 60 ml / min
Liver function
total bilirubin (TBIL) ≤ 1.5 × ULN; ALT/AST ≤ 2.5 × ULN (liver metastasis patients ≤ 5xULN)
Cardiac function
LVEF ≥ 55%, QTcF ≤ 470 ms
Adequate bone marrow functional reserve ... Liver, kidney and heart function tests were basically normal within one week before enrollment
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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