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

June 20, 2025 updated by: Zhenzhen Liu, Henan Cancer Hospital

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

180

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China
        • Recruiting
        • Henan Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Stage IV (metastatic) breast cancer.
  • Has received chemotherapy, endocrine therapy, targeted therapy, reflex therapy, etc. for this disease.
  • The patient has a second primary malignant tumor, except for fully treated skin cancer.
  • The patient had undergone major surgical procedures unrelated to breast cancer within 4 weeks before enrollment, or the patient has not fully recovered from such surgical procedures.
  • The presence of uncontrolled cardiovascular and cerebrovascular disease, including (but not limited to) any of the following within the 6 months prior to the first dose: congestive heart failure (NYHA III or IV), myocardial infarction or cerebral infarction, pulmonary embolism, unstable angina, or arrhythmia requiring treatment at the time of screening; Primary cardiomyopathy (e.g., dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restricted cardiomyopathy, undefined cardiomyopathy); A clinically significant history of prolonged QTc, grade II type II atrioventricular block or grade III atrioventricular block or QTc interphase (F method) > 470 msec (female); Atrial fibrillation (EHRA grade ≥2b); Unmanageable hypertension, which the investigators judged unsuitable for study participation.
  • Due to serious and uncontrollable other medical diseases, researchers believe that there are contraindications to chemotherapy.
  • Individuals with a known history of allergies to the drug components of this protocol;
  • Having a history of immunodeficiency, including HIV testing positive, or suffering from other acquired or congenital immunodeficiency diseases, or having a history of organ transplantation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1：SHR-A1811+Pertuzumab
Participants will receive SHR-A1811+Pertuzumab for 6 cycles.
Drug: SHR-A1811
an anti-HER2 antibody-drug conjugate (ADC)
Drug: Pertuzumab
Pertuzumab
Experimental: Cohort 2：SHR-A1811+Pertuzumab+Albumin-Paclitaxel
Participants will receive SHR-A1811+Pertuzumab+Albumin-Paclitaxel for 6 cycles.
Drug: SHR-A1811
an anti-HER2 antibody-drug conjugate (ADC)
Drug: Pertuzumab
Pertuzumab
Drug: Albumin-Paclitaxel
Nab paclitaxel
Active Comparator: Cohort 3：TCbHP
Participants will receive Docetaxel +Carboplatin +Trastuzumab +Pertuzumab for 6 cycles.
Drug: Trastuzumab
Trastuzumab
Drug: Docetaxel
Docetaxel
Drug: Carboplatin
Carboplatin
Drug: Pertuzumab
Pertuzumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pathological complete response rate (pCR rate)
Time Frame: After surgery（within 1 month）
After neoadjuvant chemotherapy and surgery, the resected specimen (breast + axilla) was free of any invasive cancer (ie, ypT0/is, ypN0)
After surgery（within 1 month）

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Invasive Disease Free Survival of 5 years
Time Frame: 5-year
5-year Invasive Disease-Free Survival was defined as patients who did not experience regional, contralateral or distant recurrence, or dies during a follow-up period of at least 5 years from the date of surgery.
5-year
Event-Free Survival of 5 years
Time Frame: 5-year
5-year Event-Free Survival was defined as patients who did not experience disease progression during neoadjuvant therapy, local or distant recurrence, second primary malignancy (breast or other cancer), or dies during a follow-up period of at least 5 years after treatment.
5-year
Objective Response Rate (ORR)
Time Frame: During neoadjuvant therapy before surgery（within 6 months）
ORR is the proportion of patients whose tumors have shrunk significantly over the course of treatment. Specifically, ORR includes both partial response (PR) and complete response (CR). Partial response (PR) : The maximum diameter or volume of the tumor is reduced by at least 30%, but it does not completely disappear. Complete response (CR) : The tumor disappears completely and no visible signs of cancer are confirmed by imaging tests, such as CT scans, MRI, or ultrasound.
During neoadjuvant therapy before surgery（within 6 months）
Adverse Events rate
Time Frame: 2-year
Evaluate the nature, incidence and severity of chemotherapy adverse events according to CTCAE 5.0
2-year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henan Cancer Hospital

Investigators

  • Principal Investigator: Zhenzhen Liu, Henan Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 16, 2025

Primary Completion (Estimated)

May 1, 2029

Study Completion (Estimated)

December 1, 2030

Study Registration Dates

First Submitted

March 4, 2025

First Submitted That Met QC Criteria

April 13, 2025

First Posted (Actual)

April 15, 2025

Study Record Updates

Last Update Posted (Actual)

June 23, 2025

Last Update Submitted That Met QC Criteria

June 20, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-543

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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