A Trial of SHR-A1811 Compared to Other Antitumor Therapies as Neoadjuvant Treatments in Early-stage or Locally Advanced HER2-positive Breast Cancer
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
This study is a multicenter, randomized, open-label, parallel Phase III clinical trial. 650 early-stage or locally advanced breast cancer participants will be enrolled and randomly assigned to SHR-A1811 monotherapy group (trial group) or TCbHP treatment group (control group) at a 1:1 ratio. Participants will receive neoadjuvant treatments of SHR-A1811 or TCbHP, while those who have completed neoadjuvant therapy and are suitable for surgery must undergo surgical treatment. The participants will be evaluated on tumor efficacy through postoperative pathological assessment by IRC and pathologists from the research center. The primary endpoint will be tpCR evaluated by IRC. Participants who complete surgical treatment will be followed up for at least 3 years at study endpoints such as EFS, DFS, and DDFS.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Kobiety, które wcześniej nie były leczone na raka piersi, w wieku 18-75 lat.
- •Stan ogólny pozwalający na normalne funkcjonowanie (niska ocena sprawności).
- •Potwierdzony rak piersi HER2-pozytywny.
- •Wyniki badań laboratoryjnych spełniające wymagania.
- •Negatywny wynik testu ciążowego i zgoda na stosowanie antykoncepcji.
- •Wyrażenie zgody na udział w badaniu.
✗ Disqualifies
- •Rak piersi HER2-negatywny.
- •Wcześniejsze leczenie lub choroby związane z rakiem piersi.
- •Poważne choroby współistniejące lub wcześniejsze leczenie ich.
- •Alergia na badany lek.
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Last updated (source)
- January 30, 2026
- Sex
- Female only
Therapies / drugs in trial
Locations (2)
Shengjing Hospital, China Medical University
Shenyang, China
Fudan University Shanghai Cancer Center
Shanghai, China
Trial contact
Contact information from ClinicalTrials.gov. Contact in English.
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.