RecruitingPhase 2NCT06927180

SHR-A1811 Plus Pertuzumab in the Neoadjuvant Treatment of HER2 Positive BC

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.


Sponsor

Henan Cancer Hospital

Enrollment

180 participants

Start Date

Apr 16, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of SHR-A1811 (an antibody-drug conjugate targeting HER2) plus pertuzumab (a HER2-blocking antibody) as pre-surgery (neoadjuvant) treatment for patients with HER2-positive breast cancer, to see if this combination can shrink tumours before surgery more effectively. **You may be eligible if...** - You are between 18 and 70 years old with good general health (ECOG 0–1) - You have confirmed HER2-positive invasive breast cancer (stage T2–T4, any lymph node status, no distant spread) - Your tumour can be measured on ultrasound, mammography, or MRI - Your blood counts and organ function are within acceptable ranges for chemotherapy **You may NOT be eligible if...** - Your breast cancer is HER2-negative or in situ (non-invasive) only - You have already received treatment for this breast cancer - You have evidence of cancer spread to distant organs - You have significant heart disease or prior serious cardiac events Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSHR-A1811

an anti-HER2 antibody-drug conjugate (ADC)

DRUGPertuzumab

Pertuzumab

DRUGAlbumin-Paclitaxel

Nab paclitaxel

DRUGDocetaxel

Docetaxel

DRUGCarboplatin

Carboplatin

DRUGTrastuzumab

Trastuzumab


Locations(1)

Henan Cancer Hospital

Zhengzhou, Henan, China

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NCT06927180


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