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

Triple Negative Breast Cancer Clinical Trial

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04405505
• Other study ID #: TQB2450-III-06
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: June 1, 2020
• Est. completion date: July 1, 2022

Study information

• Verified date: May 2020
• Source: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Contact: Binghe Xu, Doctor
• Phone: 010-87788826
• Email: xubinghe[@]medmail.com.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 332
• Est. completion date: July 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Triple Negative Breast Cancer
• Triple Negative Breast Neoplasms

Intervention

Drug:
• TQB2450
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.
• Anlotinib
a multi-target receptor tyrosine kinase inhibitor.
• Paclitaxel for Injection (albumin bound)
a anti-microtubule drug.

Locations

Country	Name	City	State
China	AnYang Tumor Hospital	Anyang	Henan
China	Beijing Shijitan Hospital Affiliated to Capital Medical University	Beijing	Beijing
China	Beijing Tsinghua Changgung Hospital	Beijing	Beijing
China	Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College	Beijing	Beijing
China	Chinese Academy of Medical Sciencesand Peking Union Medical College Hospital	Beijing	Beijing
China	The First Hospital of Jilin University	Changchun	Jilin
China	Hunan Cancer Hospital	Changsha	Hunan
China	Chongqing Cancer Hospital	Chongqing	Chongqing
China	The First Affilited Hospital of Chongqing Medical University	Chongqing	Chongqing
China	Guangdong Provincial People's Hospital	Guangzhou	Guangdong
China	The Second Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang
China	Affiliated Tumor Hospital of Harbin Medical University	Harbin	Heilongjiang
China	The Fourth Affiliated Hospital of Anhui Medical University	Hefei	Anhui
China	Qilu Hospital of Shandong University	Jinan	Shandong
China	Guangxi Medical University Affiliated Tumor Hospital	Nanning	Guangxi Zhuang Autonomous Region
China	The First Affiliated Hospital of Guangxi Medical University	Nanning	Guangxi Zhuang Autonomous Region
China	Nantong Tumor Hospital	Nantong	Jiangsu
China	The Second People's Hospital of Neijiang	Neijiang	Sichuan
China	Liaoning Cancer Hospital & Institute	Shenyang	Liaoning
China	The First Hospital of China Medical University	Shenyang	Liaoning
China	The fourth Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	Shanxi Cancer Hospital	Taiyuan	Shanxi
China	Tianjin Cancer Hospital	Tianjin	Tianjin
China	Xinjiang Uiger Municipal People's Hospital	Urumqi	Xinjiang
China	Zhongnan Hospital of Wuhan University	Wuhan	Hubei
China	Shanxi Provincial People's Hospital	Xi'an	Shanxi
China	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shanxi
China	The Second Affiliated Hospital of PLA Airforce Military Medical University	Xi'an	Shanxi
China	Yanbian University Hospital	Yanji	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall response rate (ORR)	Percentage of participants achieving complete response (CR) and partial response (PR).	up to 96 weeks
Secondary	Disease control rate(DCR)	Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).	up to 96 weeks
Secondary	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