A Trial of SHR-A1811 Compared to Other Antitumor Therapies as Neoadjuvant Treatments in Early-stage or Locally Advanced HER2-positive Breast Cancer

NCT07196774 | Recruiting Phase 3

• 1 other identifier: SHR-A1811-312
• Study Type: interventional
• Target: 740
• Locations: 1 country
• Sites: 2

Brief Summary

This study is a multicenter, randomized, open-label, parallel Phase III clinical trial. 650 early-stage or locally advanced breast cancer participants will be enrolled and randomly assigned to SHR-A1811 monotherapy group (trial group) or TCbHP treatment group (control group) at a 1:1 ratio. Participants will receive neoadjuvant treatments of SHR-A1811 or TCbHP, while those who have completed neoadjuvant therapy and are suitable for surgery must undergo surgical treatment. The participants will be evaluated on tumor efficacy through postoperative pathological assessment by IRC and pathologists from the research center. The primary endpoint will be tpCR evaluated by IRC. Participants who complete surgical treatment will be followed up for at least 3 years at study endpoints such as EFS, DFS, and DDFS.

Conditions

Early-stage or Locally Advanced HER2-positive Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Postoperative total pathologic complete response (tpCR) evaluated by Independent Review Committee (IRC) after finishing neoadjuvant treatments.

  From the enrollment of the first subject to the end of the study, it lasted about 36 months.

Secondary Outcomes (5)

• Postoperative total pathologic complete response (tpCR) evaluated pathologists at the research center after finishing neoadjuvant treatments.

  From the enrollment of the first subject to the end of the study, it lasted about 36 months.

• Event-free survival (EFS).

  Followed up for at least 3 years.

• Disease-free survival (DFS).

  Followed up for at least 3 years.

• Distant disease-free survival (DDFS).

  Followed up for at least 3 years.

• Objective response rate (ORR) assessed according to the preoperative evaluation utilizing RECIST v1.1 after finishing neoadjuvant treatments.

  Followed up for at least 3 years.

Study Arms (2)

SHR-A1811 Group

EXPERIMENTAL

Drug: SHR-A1811 for Injection

Docetaxel+Carboplatin+Trastuzumab+Pertuzumab Group

ACTIVE COMPARATOR

Drug: Docetaxel injection; Drug: Trastuzumab Injection; Drug: Carboplatin for Injection; Drug: Pertuzumab Injection

Interventions

SHR-A1811 for Injection DRUG

SHR-A1811 for injection.

SHR-A1811 Group

Docetaxel injection DRUG

Docetaxel injection.

Docetaxel+Carboplatin+Trastuzumab+Pertuzumab Group

Trastuzumab Injection DRUG

Trastuzumab injection.

Docetaxel+Carboplatin+Trastuzumab+Pertuzumab Group

Carboplatin for Injection DRUG

Carboplatin for injection.

Docetaxel+Carboplatin+Trastuzumab+Pertuzumab Group

Pertuzumab Injection DRUG

Pertuzumab injection.

Docetaxel+Carboplatin+Trastuzumab+Pertuzumab Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females treated for the first time, 18-75 years old;
• ECOG score 0-1;
• Has pathological diagnosis that meets the criteria: confirmed HER2 positive;
• Results of laboratory tests meet the enrollment requirements;
• Pregnancy test result must be negative and must agree to contraception;
• Has signed the informed consent form.

You may not qualify if:

• Confirmed HER2 negative;
• Has tumor-related medical history or treatment history;
• Has severe combined disease/medical history and treatment history;
• Has received treatment with systemic immunostimulants or immunosuppressants;
• Be allergic to the test drug;
• Participate in other clinical trials simultaneously;
• Has received vaccine within 30 days before the first dose;
• Has received allograft bone marrow transplantation;
• Has given birth within one year or is breastfeeding;
• Has history of psychological drug abuse, alcoholism or drug use.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (2)

Shengjing Hospital, China Medical University

Shenyang, Liaoning, 110000, China

RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Interventions

Injections; Docetaxel; Trastuzumab; Carboplatin; pertuzumab

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Yang Wu

CONTACT

+86-0518-82342973; yang.wu.yw96@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2025
• First Posted: September 29, 2025
• Study Start: October 23, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: January 30, 2026

Record last verified: 2026-01

Locations

CN (2)