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

Official record

Identifier

NCT07196774

Recruiting locations

country

China

Interventions studied

SHR-A1811 for InjectionDocetaxel injectionTrastuzumab InjectionCarboplatin for InjectionPertuzumab Injection

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Target enrolment

740 participants

Study type

INTERVENTIONAL

Phase

Phase 3

Status

Active, not recruiting

First posted

Sep 29, 2025

Last updated on the registry

Jul 30, 2026

Age

18 Years – 75 Years

Sex

FEMALE

Study contact

No public contact is listed on the official record.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

Inclusion Criteria:

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

Exclusion Criteria:

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

Indexed under

Breast Cancer