A Study of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsule Versus Paclitaxel for Injection (Albumin Bound) in Subjects With Triple Negative Breast Cancer (TNBC)

Study Overview
=================
Brief Summary
-----------------
This study is a randomized, positive parallel controlled, multicentre phase III clinical trial to evaluate the efficacy and safety of TQB2450 combined with anlotinib versus paclitaxel for injection (albumin bound) in subjects with advanced triple negative breast cancer.

Official Title
-----------------
A Randomized, Positive Parallel Controlled, Multicenter Phase III Study of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsule Versus Paclitaxel for Injection (Albumin Bound) in Subjects With Triple Negative Breast Cancer (TNBC)

Conditions
-----------------
Triple Negative Breast Cancer

Intervention / Treatment
-----------------
* Drug: TQB2450
* Drug: Anlotinib
* Drug: Paclitaxel for Injection (albumin bound)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1.Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy ≥ 3 months. 2.Histologically confirmed triple negative breast cancer. 3.Has at least one measurable lesion. 4.Newly diagnosed stage IV or recurrent/metastatic triple negative breast cancer who are not suitable for surgery. 5.Prior local radiotherapy for metastatic sites is allowed. 6.Adequate laboratory indicators. 7.Understood and signed an informed consent form. 8.No pregnant or breastfeeding women, and a negative pregnancy test. Exclusion Criteria: 1.Has received anti-angiogenic drugs or other PD-1 / PD-L1 / CTLA-4 antibody therapy or other immunotherapy against PD-1 / PD-L1 / CTLA-4. 2. Severe hypersensitivity occurs after administration of other monoclonal antibodies. 3. Has other malignancies (except cured skin basal cell carcinoma and cervical carcinoma in situ) within 3 years. 4. Has any active autoimmune disease or history of autoimmune disease. 5. Has a clear clinical diagnosis of interstitial pneumonia, pulmonary fibrosis, drug-induced pneumonia, or active pneumonia. 6. Peripheral neuropathy ≥ grade 2. 7. Immunosuppressant or systemic or absorbable local hormone therapy is required to achieve the aim of immunosuppression (dose &gt; 10mg/ day prednisone or other therapeutic hormones) and is still used within 2 weeks after the first administration. 8. Has multiple factors affecting oral medication. 9. Has uncontrolled and repeated drainage pleural effusion, pericardial effusion, and ascites. 10. Has any signs of bleeding or history. 11. Has unrelieved spinal cord compression. 12. Has symptomatic central nervous system (CNS) disease and / or cancerous meningitis, pia mater disease. 13. Has received other anti-tumor therapy within 4 weeks before the first administration. 14. Has any serious and/or uncontrollable disease. 15. Has received vaccination or attenuated vaccine within 4 weeks before the first administration. 16. According to the judgement of the investigators, there are other factors that may lead to the termination of the study.

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

Sexes Eligible for Study
-----------------
All

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: TQB2450 + Anlotinib<br>TQB2450 1200 mg administered intravenously (IV) on Day 1 of each 21-day cycle ,Anlotinib capsules 12 mg given orally, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21). | Drug: TQB2450<br>* TQB2450 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on T cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors.<br>Drug: Anlotinib<br>* a multi-target receptor tyrosine kinase inhibitor.<br>|
| Active Comparator: Paclitaxel for injection (albumin bound)<br>Paclitaxel for Injection (albumin bound) 100mg / m2 administered intravenously (IV) on Day 1, 8, 15 in 28-day cycle. | Drug: Paclitaxel for Injection (albumin bound)<br>* a anti-microtubule drug.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival (PFS) evaluated by Independent Review Committee(IRC) | PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause, based on IRC. | up to 96 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate (ORR) | Percentage of participants achieving complete response (CR) and partial response (PR). | up to 96 weeks | 
| Disease control rate（DCR） | Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD). | up to 96 weeks | 
| Duration of Response (DOR) | DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment. | up to 96 weeks |