SHR-A1811 Plus Pertuzumab in the Neoadjuvant Treatment of HER2 Positive BC
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
The goal of this clinical trial is to evaluate the efficacy and safety of SHR-A1811 plus pertuzumab in combination with or without albumin-paclitaxel neoadjuvant therapy for early or locally advanced HER2-positive breast cancer. The main questions it aims to answer are: * Does the pCR of SHR-A1811 plus pertuzumab with or without albumin-paclitaxel improve compared to the current standard of treatment? * Is the safety of SHR-A1811 plus pertuzumab with or without albumin-paclitaxel better compared to the current standard of treatment? Researchers will compare SHR-A1811+pertuzumab or SHR-A1811+pertuzumab+albumin-paclitaxel to TCbHP to see if SHR-A1811 plus pertuzumab with or without albumin-paclitaxel works to treat early or locally advanced HER2-positive breast cancer. Subjects will be randomly assigned 1:1:1 to： * cohort 1：SHR-A1811 combined with pertuzumab for 6 cycles; * cohort 2：SHR-A1811 combined with pertuzumab and albumin-paclitaxel for 6 cycles; * cohort 3：TCbHP (docetaxel, carboplatin, trastuzumab and pertuzumab) for 6 cycles. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, questionnaires, and scans.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek od 18 do 70 lat.
- •W stadium raka piersi zwanym wczesnym lub miejscowo zaawansowanym (nieprzerzutowym).
- •Rak piersi HER2-dodatni, potwierdzony badaniami.
- •Dobre ogólne samopoczucie i brak przeciwwskazań do chemioterapii.
- •Prawidłowa praca serca (oceniana za pomocą USG).
- •Kobiety w wieku rozrodczym muszą mieć negatywny test ciążowy.
✗ Disqualifies
- •Rak piersi z przerzutami (stadium IV).
- •Przed rozpoczęciem badania pacjent już przyjmował niektóre leki na raka piersi.
- •Obecność innych, poważnych chorób niezwiązanych z rakiem piersi, które nie są pod kontrolą.
- •Zabieg operacyjny w ciągu ostatnich 4 tygodni przed badaniem, który nie jest związany z rakiem piersi.
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 70 Years
- Last updated (source)
- June 23, 2025
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
Henan Cancer Hospital
Zhengzhou, China
Trial contact
Zhenzhen Liu
Contact information from ClinicalTrials.gov. Contact in English.
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.