SKB264 Combined With KL-A167 Neoadjuvant Therapy for Early-stage, High-risk ER+/HER2- Breast Cancer

No open prediction endpoints

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Key Facts

Primary Endpoints (CT.gov)

Secondary Endpoints

Eligibility Criteria

Inclusion Criteria: 1. Females aged 18-70 years; 2. Pathologically confirmed invasive ductal breast cancer and untreated previously； 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; 4. Life expectancy ≥3 months; 5. Have at least 1 measurable disease defined by RECIST v1.1; 6. T1c-T2 (tumor size ≥2 cm), clinical node stage (cN)1-cN2, or T3-T4, cN0-cN2; 7. Has confirmed ER+/HER2-：ER≥1%、HER2 IHC 0、1+ or 2+/ISH-）; 8. Tumor Grade 3 of ductal histology, Or Tumor Grade 2 of ductal histology having an ER expression level percentage between 1-10% 9. Tissue or blood available for biomarker assessment; 10. Adequate organ function; 11. Patients with negative serum pregnancy test and those with fertility potential must agree to use effective contraception during the treatment period and for at least 3 months after the last dose of study drugs; 12. Patients must voluntarily participate in this study, sign an informed consent form, exhibit good compliance, and be willing to…

✦ Analyst Commentary

Expert commentary on why this trial matters and what to watch for.

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