Early-stage or Locally Advanced HER2-positive Breast Cancer
Conditions
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.
Interventions
Trastuzumab injection.
Pertuzumab injection.
DRUGCarboplatin for Injection
Carboplatin for injection.
SHR-A1811 for injection.
DRUGDocetaxel injection
Docetaxel injection.
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. |
Countries
China
Contacts
CONTACTYang Wu
Outcome results
None listed