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ClinicalTrials.gov ID

NCT04405505

Lead Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.INDUSTRY

Overall Status

Unknown status

Study Type

Interventional

Phase

Phase 3

Enrollment

332Estimated

Last Update Posted

May 28, 2020Actual

Start Date

Jun 1, 2020Estimated

Primary Completion Date

Jul 1, 2022Estimated

Completion Date

Jul 1, 2022Estimated

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)

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.

• Triple Negative Breast Cancer

• TQB2450
• Anlotinib
• Paclitaxel for Injection (albumin bound)

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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 > 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.

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.INDUSTRY

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