Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06927180
PHASE2

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

Sponsor: Henan Cancer Hospital

View on ClinicalTrials.gov

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

DRUG

SHR-A1811

an anti-HER2 antibody-drug conjugate (ADC)

DRUG

Pertuzumab

Pertuzumab

DRUG

Albumin-Paclitaxel

Nab paclitaxel

DRUG

Docetaxel

Docetaxel

DRUG

Carboplatin

Carboplatin

DRUG

Trastuzumab

Trastuzumab

Locations (1)

Henan Cancer Hospital

Zhengzhou, Henan, China