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

NCT06927180 | Recruiting Phase 2

• 1 other identifier: 2024-543
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer Early Stage Breast Cancer (Stage 1-3)

Keywords

Breast Cancer; HER2-positive Breast Cancer; pathologic complete response; SHR-A1811; Pertuzumab; Albumin-Paclitaxel

Outcome Measures

Primary Outcomes (1)

• Pathological complete response rate (pCR rate)

  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 Outcomes (4)

• Invasive Disease Free Survival of 5 years

  5-year

• Event-Free Survival of 5 years

  5-year

• Objective Response Rate (ORR)

  During neoadjuvant therapy before surgery（within 6 months）

• Adverse Events rate

  2-year

Study Arms (3)

Cohort 1：SHR-A1811+Pertuzumab

EXPERIMENTAL

Participants will receive SHR-A1811+Pertuzumab for 6 cycles.

Drug: SHR-A1811; Drug: Pertuzumab

Cohort 2：SHR-A1811+Pertuzumab+Albumin-Paclitaxel

EXPERIMENTAL

Participants will receive SHR-A1811+Pertuzumab+Albumin-Paclitaxel for 6 cycles.

Drug: SHR-A1811; Drug: Pertuzumab; Drug: Albumin-Paclitaxel

Cohort 3：TCbHP

ACTIVE COMPARATOR

Participants will receive Docetaxel +Carboplatin +Trastuzumab +Pertuzumab for 6 cycles.

Drug: Pertuzumab; Drug: Docetaxel; Drug: Carboplatin; Drug: Trastuzumab

Interventions

SHR-A1811 DRUG

an anti-HER2 antibody-drug conjugate (ADC)

Cohort 1：SHR-A1811+Pertuzumab; Cohort 2：SHR-A1811+Pertuzumab+Albumin-Paclitaxel

Pertuzumab DRUG

Pertuzumab

Cohort 1：SHR-A1811+Pertuzumab; Cohort 2：SHR-A1811+Pertuzumab+Albumin-Paclitaxel; Cohort 3：TCbHP

Albumin-Paclitaxel DRUG

Nab paclitaxel

Cohort 2：SHR-A1811+Pertuzumab+Albumin-Paclitaxel

Docetaxel DRUG

Docetaxel

Cohort 3：TCbHP

Carboplatin DRUG

Carboplatin

Cohort 3：TCbHP

Trastuzumab DRUG

Trastuzumab

Cohort 3：TCbHP

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Henan Cancer Hospital: lead

Study Sites (1)

Henan Cancer Hospital

Zhengzhou, Henan, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Pathologic Complete Response

Interventions

pertuzumab; Docetaxel; Carboplatin; Trastuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Disease Progression; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Zhenzhen Liu

  Henan Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhenzhen Liu

CONTACT

86+13603862755; liuzhenzhen73@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Non
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Patients who meet the inclusion criteria were randomly divided into SHR-A1811+pertuzumab and SHR-A1811+pertuzumab+albumin-paclitaxel and TCbHP group in a 1:1:1 ratio.

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: April 15, 2025
• Study Start: April 16, 2025
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): December 1, 2030
• Last Updated: June 23, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)