OncoMatch/Clinical Trials/NCT06236269
HR+/HER2- Advanced or Metastatic Breast Cancer Patients Treated With Sacituzumab Govitecan
Is NCT06236269 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Sacituzumab Govitecan for breast cancer stage iv.
Treatment: Sacituzumab Govitecan — This is an open-label, single arm, non-randomized, multicenter phase II study for the identification of predictive biomarkers of sacituzumab govitecan benefit and the understanding of key resistance mechanisms in HR+/HER2- advanced/metastatic breast cancer patients
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 overexpression (>1% of cells expressing ER via IHC)
ER and/or PR positivity are defined as >1% of cells expressing HR via IHC analysis as per most recent ASCO-CAP guideline
Required: PR (PGR) overexpression (>1% of cells expressing PR via IHC)
ER and/or PR positivity are defined as >1% of cells expressing HR via IHC analysis as per most recent ASCO-CAP guideline
Required: HER2 (ERBB2) wild-type (IHC 0, IHC 1+, or IHC2+/ISH-)
HER2 negativity is defined as either of the following by local laboratory assessment: IHC 0, IHC 1+ or IHC2+/in situ hybridization (ISH) negative
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: CDK4/6 inhibitor — adjuvant or advanced/metastatic
Disease refractory to CDK4/6 inhibitors, defined as recurrence during or within 12 months after the end of adjuvant treatment or progression during or within 6 months after the end of treatment for advanced/metastatic disease.
Cannot have received: antibody-drug conjugate (sacituzumab govitecan)
Prior treatment with Sacituzumab-govitecan.
Lab requirements
Blood counts
Haemoglobin ≥ 9.0 g/dL (no transfusion/growth factor support within 1 week); ANC ≥ 1.5 x 10^9/L; Platelet count ≥ 100 x 10^9/L; Serum albumin >3 g/dL; INR/PT/aPTT ≤ 1.5 × ULN
Kidney function
Creatinine ≤ 1.5 x ULN or Creatinine clearance ≥30mL/min (Cockcroft-Gault)
Liver function
Total bilirubin ≤ 1.5 × ULN or ≤ 3 × ULN in Gilbert's; AST/ALT ≤ 2.5 x ULN unless liver metastases present, then ≤ 5x ULN
Patients must have normal organ and bone marrow function measured within 35 days prior to administration of study treatment as defined below: ... (see full criteria for details)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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