OncoMatch/Clinical Trials/NCT05205200
Immune Therapy in HR-positive/HER2-negative Metastatic Breast Cancer(ENIGMA)-BCTOP-L-M02
Is NCT05205200 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for breast cancer.
Treatment: SHR-1316 · SHR6390 · Nab paclitaxel · SERD · AI — This study is a prospective, open-label, phase II clinical study for patients with HR+/HER2- advanced breast cancer.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Tumor Agnostic
Biomarker criteria
Required: ESR1 overexpression (ER > 10% tumor cell positive)
immunohistochemical detection of ER> 10% tumor cell positive is defined as ER positive
Required: PR (PGR) overexpression (PR > 10% tumor cell positive)
PR> 10% tumor cell positive is defined as PR positive
Required: HER2 (ERBB2) negative (HER2 0-1+ or HER2 is ++ but negative by FISH, no amplification)
HER2 0-1 + or HER2 is ++ but negative followed by FISH detection, no amplification, defined as HER2 negative
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: chemotherapy
Exception: for metastatic disease only
Treatment with chemotherapy ... for metastatic disease
Cannot have received: targeted therapy
Exception: for metastatic disease only
Treatment with ... targeted therapy for metastatic disease
Cannot have received: radiotherapy
Exception: for metastatic disease only
Treatment with ... radiotherapy ... for metastatic disease
Cannot have received: immunotherapy
Exception: for metastatic disease only
Treatment with ... immunotherapy ... for metastatic disease
Cannot have received: surgery
Exception: outpatient clinic surgery excluded; for metastatic disease only
Treatment with ... surgery (outpatient clinic surgery excluded) for metastatic disease
Lab requirements
Blood counts
absolute neutrophil count > 1.5x10^9 /L; platelet count > 75x10^9 /L, hemoglobin > 9g/dL
Kidney function
Has adequate kidney function: serum creatinine
Liver function
Has adequate liver function
Has adequate bone marrow function: absolute neutrophil count > 1.5x10^9 /L; platelet count > 75x10^9 /L, hemoglobin > 9g/dL; Has adequate liver function and kidney function: serum creatinine
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify