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SHR-A1811 Plus Pertuzumab in the Neoadjuvant Treatment of HER2 Positive BC
Sponsor: Henan Cancer Hospital
Summary
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.
Official title: SHR-A1811 Plus Pertuzumab in Combination With or Without Albumin-paclitaxel as Neoadjuvant Treatment for Early or Locally Advanced HER2-positive Breast Cancer:A Prospective, Randomized, Open-label, Phase II Trial.
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
180
Start Date
2025-04-16
Completion Date
2030-12-01
Last Updated
2025-06-23
Healthy Volunteers
No
Interventions
SHR-A1811
an anti-HER2 antibody-drug conjugate (ADC)
Pertuzumab
Pertuzumab
Albumin-Paclitaxel
Nab paclitaxel
Docetaxel
Docetaxel
Carboplatin
Carboplatin
Trastuzumab
Trastuzumab
Locations (1)
Henan Cancer Hospital
Zhengzhou, Henan, China