OncoMatch/Clinical Trials/NCT06081959
Study of SKB264 for Locally Advanced, Recurrent or Metastatic HR+/HER2- Breast Cancer
Is NCT06081959 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies multiple treatments for metastatic breast cancer.
Treatment: SKB264 · Eribulin · Capecitabine · Gemcitabine · Vinorelbine — The purpose of this study is to evaluate the efficacy and safety of SKB264 in patients with unresectable locally advanced, recurrent, or metastatic HR+/HER2- breast cancer.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Other
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) negative
Required: ESR1 positive
Required: PR (PGR) positive
Disease stage
Required: Stage III, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Must have received: systemic chemotherapy — unresectable locally advanced, recurrent, or metastatic
Patients who had failed at least one line of systemic chemotherapy in unresectable locally advanced, recurrent, or metastatic stage
Cannot have received: TROP2 targeted therapy
Prior TROP2 targeted therapy
Cannot have received: topoisomerase I inhibitor
prior topoisomerase I inhibitor therapy, including antibody-drugconjugate(ADC) therapy
Lab requirements
Blood counts
adequate organ and bone marrow function
Kidney function
adequate organ and bone marrow function
Liver function
adequate organ and bone marrow function
Adequate organ and bone marrow function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06081959 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior TROP2 targeted therapy, topoisomerase I inhibitor disqualifies patients from enrollment.
Does this trial require ERBB2?
Yes, ERBB2 negative is a required biomarker for enrollment.
Does this trial require ESR1?
Yes, ESR1 positive is a required biomarker for enrollment.
Does this trial require PGR?
Yes, PGR positive is a required biomarker for enrollment.
What disease stage is eligible?
Stage III or IV is required.
Is there an age limit?
Yes. Patients must be 75 years or younger.
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