This study aimed to evaluate the efficacy and safety of SKB264 combined with KL-A167 as neoadjuvant therapy in early-stage high-risk ER+HER2- breast cancer patients.
Females aged 18-70 years;
Pathologically confirmed invasive ductal breast cancer and untreated previously；
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1;
Life expectancy ≥3 months;
Inflammatory BC；
Has multi-centric breast cancer (presence of more than 1 tumor in different quadrants of the breast).
Has bilateral invasive breast cancer.
Has metastatic (stage IV) breast cancer.
Single group
Sacituzumab tirumotecan
Biological/VaccineSacituzumab tirumotecan 5 mg/kg, intravenously (iv), Q2W
Tagitanlimab
Biological/VaccineTagitanlimab 900mg, intravenously (iv), Q2W
Pathological Complete Response (pCR) Rate (ypT0/Tis ypN0)
No microscopically detectable remnants of aggressive tumors in breast and axillary lymph nodes, ductal carcinoma in situ is allowed
pCR Rate (ypT0/Tis)
No microscopically detectable remnants of aggressive tumors in breast, ductal carcinoma in situ is allowed.
Objective response rate (ORR)
The percentage of participants with CR or PR as the best response during the neoadjuvant treatment, based on RECIST v1.1.
Event-Free Survival (EFS)
The time from the first treatment to disease progression that: precludes surgery, results in a local or distant recurrence, results in a second primary malignancy, or death due to any cause whichever occurs first.
Overall Survival (OS)
The time from the date of first treatment to date of death due to any cause.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
