HER2-PositiveRecurrent or Metastatic Breast Cancer
Conditions
Brief summary
To evaluate the efficacy and safety of SHR-A1811 with or without pertuzumab versus trastuzumab, pertuzumab and docetaxel in HER2-Positive Recurrent or Metastatic Breast Cancer
Interventions
SHR-A1811 Injection
DRUGSHR-A1811 Injection ； Pertuzumab Injection
SHR-A1811 Injection ； Pertuzumab Injection
DRUGTrastuzumab Injection；Pertuzumab Injection ； Docetaxel Injection
Trastuzumab Injection；Pertuzumab 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. Women aged 18 to 75 (inclusive) 2. HER2 positive (IHC3+ or ISH+) unresectable or metastatic breast cancer confirmed by histology or cytology. 3. ECOG score is 0 or 1 4. An expected survival of ≥ 12 weeks 5. At least one measurable lesion according to RECIST v1.1 criteria 6. Have adequate renal and hepatic function 7. Patients voluntarily joined the study and signed informed consent
Exclusion criteria
1. Have other malignancies within the past 5 years 2. Active central nervous system metastasis without surgery or radiotherapy 3. In (neoadjuvant) adjuvant therapy phase, the interval from the end of systemic therapy (excluding endocrine therapy) to the detection of recurrence/metastasis ≤12 months 4. Presence with uncontrollable third space effusion 5. Have undergone other anti-tumor treatment within 4 weeks before the first dose 6. A history of immune deficiency 7. Clinically significant cardiovascular disorders 8. Known or suspected interstitial lung disease 9. The toxicity from previous anti-tumor treatment has not recovered to ≤ grade I 10. Known hereditary or acquired bleeding tendency 11. Active hepatitis and liver cirrhosis 12. Presence of other serious physical or mental diseases or laboratory abnormalities
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival by Blinded Independent Central Review | from first dose to disease progression, or death, whichever comes first, up to 3 years |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival by investigators | from first dose to disease progression, or death, whichever comes first, up to 3 years |
| Overall Survival | from first dose to death, up to 6 years |
| Objective Response Rate | from first dose to disease progression or death, whichever comes first, up to 3 years |
| Duration of response | from first dose to disease progression or death, whichever comes first, up to 3 years |
| AE | from Day1 to 40 or 90 days after last dose |
| Incidence and severity of serious adverse events (SAE) | from Day1 to 40 or 90 days after last dose |
Countries
China
Outcome results
None listed