OncoMatch/Clinical Trials/NCT05814354
SHR-A1811 Versus Investigator's Chemotherapy in Recurrent/Metastatic Breast Cancer Clinical Trial
Is NCT05814354 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies multiple treatments including SHR-A1811 and Capecitabine/Eribulin/Gemcitabine/Paclitaxel/Nab-paclitaxel for breast cancer.
Treatment: SHR-A1811 · Capecitabine/Eribulin/Gemcitabine/Paclitaxel/Nab-paclitaxel — The aim of this study was to evaluate whether the progression-free survival of SHR-A1811 was superior to investigator-selected chemotherapy in patients with HER2-low recurrent/metastatic breast cancer. To evaluate whether SHR-A1811 is superior to investigator-selected chemotherapy in patients with HER2-low recurrent/metastatic breast cancer.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Other
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) low expression (IHC 2+/ISH- or IHC 1+ [ISH- or untested]) (IHC 2+/ISH- or IHC 1+ (ISH- or untested))
Low-HER2 expression defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested).
Required: ESR1 positive
HR-positive breast cancer
Disease stage
Metastatic disease required
Demographics
Prior therapy
Must have received: endocrine therapy — metastatic
Lab requirements
Blood counts
protocol-defined adequate bone marrow function
Kidney function
protocol-defined adequate renal function
Liver function
protocol-defined adequate hepatic function
Cardiac function
protocol-defined adequate cardiac function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT05814354 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received endocrine therapy.
Does this trial require ERBB2?
Yes, ERBB2 low expression (IHC 2+/ISH- or IHC 1+ [ISH- or untested]) is a required biomarker for enrollment.
Does this trial require ESR1?
Yes, ESR1 positive 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