A Phase III Study of SHR-A1811 Injection With or Without Pertuzumab in HER2-Positive Recurrent or Metastatic Breast Cancer

Study Overview
=================
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

Official Title
-----------------
A Phase III Multicenter, Randomized, Open-label, Active-Controlled Study of SHR-A1811 With or Without Pertuzumab Versus Trastuzumab, Pertuzumab and Docetaxel in HER2-Positive Recurrent or Metastatic Breast Cancer

Conditions
-----------------
HER2-PositiveRecurrent or Metastatic Breast Cancer

Intervention / Treatment
-----------------
* Drug: SHR-A1811 Injection
* Drug: SHR-A1811 Injection ； Pertuzumab Injection
* Drug: Trastuzumab Injection；Pertuzumab Injection ； Docetaxel Injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women aged 18 to 75 (inclusive) HER2 positive (IHC3+ or ISH+) unresectable or metastatic breast cancer confirmed by histology or cytology. ECOG score is 0 or 1 An expected survival of ≥ 12 weeks At least one measurable lesion according to RECIST v1.1 criteria Have adequate renal and hepatic function Patients voluntarily joined the study and signed informed consent Exclusion Criteria: Have other malignancies within the past 5 years Active central nervous system metastasis without surgery or radiotherapy In (neoadjuvant) adjuvant therapy phase, the interval from the end of systemic therapy (excluding endocrine therapy) to the detection of recurrence/metastasis ≤12 months Presence with uncontrollable third space effusion Have undergone other anti-tumor treatment within 4 weeks before the first dose A history of immune deficiency Clinically significant cardiovascular disorders Known or suspected interstitial lung disease The toxicity from previous anti-tumor treatment has not recovered to ≤ grade I Known hereditary or acquired bleeding tendency Active hepatitis and liver cirrhosis Presence of other serious physical or mental diseases or laboratory abnormalities

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group A: SHR-A1811 Injection<br> | Drug: SHR-A1811 Injection<br>* SHR-A1811 Injection<br>|
| Experimental: Treatment group B: SHR-A1811 Injection and Pertuzumab Injection<br> | Drug: SHR-A1811 Injection ； Pertuzumab Injection<br>* SHR-A1811 Injection ； Pertuzumab Injection<br>|
| Active Comparator: Treatment group C: Trastuzumab Injection, Pertuzumab Injection and Docetaxel Injection<br> | Drug: Trastuzumab Injection；Pertuzumab Injection ； Docetaxel Injection<br>* Trastuzumab Injection；Pertuzumab Injection ； Docetaxel Injection<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 |