OncoMatch/Clinical Trials/NCT05205200
Immune Therapy in HR-positive/HER2-negative Metastatic Breast Cancer(ENIGMA)-BCTOP-L-M02
Is NCT05205200 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Chemotherapy
Other
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)
Demographics
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.
Frequently asked questions
Is NCT05205200 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require ESR1?
Yes, ESR1 overexpression is a required biomarker for enrollment.
Does this trial require PGR?
Yes, PGR overexpression is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 negative is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Is this trial open to male patients?
No. This trial enrolls female patients only.
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