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

Hengrui Medicine

Status and phase: Enrolling; Phase 3

Conditions: Early-stage or Locally Advanced HER2-positive Breast Cancer

Treatments: Drug: Trastuzumab Injection; Drug: SHR-A1811 for Injection; Drug: Docetaxel injection; Drug: Pertuzumab Injection; Drug: Carboplatin for Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT07196774

SHR-A1811-312

Details and patient eligibility

About

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.

Enrollment: 740 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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740 participants in 2 patient groups

SHR-A1811 Group

Experimental group

Treatment:

Drug: SHR-A1811 for Injection

Docetaxel+Carboplatin+Trastuzumab+Pertuzumab Group

Active Comparator group

Treatment:

Drug: Carboplatin for Injection

Drug: Pertuzumab Injection

Drug: Docetaxel injection

Drug: Trastuzumab Injection