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.

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Age: 18-70 years old, ECOG 0-1 point.

• Clinical T2-T4, with any LN, M0.

• HER2+, invasive breast cancer confirmed by histopathology;(HER2 positive expression means that there is at least one case of tumor cell immunohistochemical staining intensity of 3+or positive confirmed by fluorescence in situ hybridization \[FISH\] in the pathological test/review of the primary focus conducted by the Pathology Department of the Research Center Hospital).

• Having clinically measurable lesions: measurable lesions displayed on ultrasound, mammography, or MR (optional) within the first month of randomization.

• Organ and bone marrow function tests within one month before chemotherapy indicate no contraindications to chemotherapy:Absolute value of neutrophil count ≥ 1.5 × 10\^9/L; Hemoglobin ≥ 90g/L; Platelet count ≥ 100 × 10\^9/L; Total bilirubin≤1.5 ULN (upper limit of normal value); Creatinine≤1.5 × ULN; AST/ALT ≤ 2.5 × ULN.

• Cardiac ultrasound: Left ventricular ejection fraction (LVEF ≥ 50%).

• Women of childbearing age tested negative for serum pregnancy test 7 days before randomization.

• Sign an informed consent form.

Locations
Other Locations
China
Henan Cancer Hospital
RECRUITING
Zhengzhou
Contact Information
Primary
Zhenzhen Liu
liuzhenzhen73@126.com
86+13603862755
Time Frame
Start Date: 2025-04-16
Estimated Completion Date: 2030-12-01
Participants
Target number of participants: 180
Treatments
Experimental: Cohort 1:SHR-A1811+Pertuzumab
Participants will receive SHR-A1811+Pertuzumab for 6 cycles.
Experimental: Cohort 2:SHR-A1811+Pertuzumab+Albumin-Paclitaxel
Participants will receive SHR-A1811+Pertuzumab+Albumin-Paclitaxel for 6 cycles.
Active_comparator: Cohort 3:TCbHP
Participants will receive Docetaxel +Carboplatin +Trastuzumab +Pertuzumab for 6 cycles.
Related Therapeutic Areas
Sponsors
Leads: Henan Cancer Hospital

This content was sourced from clinicaltrials.gov