Overview

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

Status:
Not yet recruiting
Trial end date:
2022-07-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Treatments:
Paclitaxel
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 >
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.