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

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)

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.

Study Overview

• Status: Unknown
• Conditions: Triple Negative Breast Cancer
• Intervention / Treatment: Drug: TQB2450; Drug: Anlotinib; Drug: Paclitaxel for Injection (albumin bound)

• Study Type: Interventional
• Enrollment (Anticipated): 332
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230022
      • The Fourth Affiliated Hospital of Anhui Medical University
  • Beijing
    • Beijing, Beijing, China, 102218
      • Beijing Tsinghua Changgung Hospital
    • Beijing, Beijing, China, 100032
      • Chinese Academy of Medical Sciencesand Peking Union Medical College Hospital
    • Beijing, Beijing, China, 100038
      • Beijing Shijitan Hospital Affiliated to Capital Medical University
    • Beijing, Beijing, China
      • Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
  • Chongqing
    • Chongqing, Chongqing, China, 400000
      • Chongqing Cancer Hospital
    • Chongqing, Chongqing, China, 400042
      • The First Affilited Hospital of Chongqing Medical University
  • Guangdong
    • Guangzhou, Guangdong, China, 510030
      • Guangdong Provincial People's Hospital
  • Guangxi Zhuang Autonomous Region
    • Nanning, Guangxi Zhuang Autonomous Region, China, 530021
      • Guangxi Medical University Affiliated Tumor Hospital
    • Nanning, Guangxi Zhuang Autonomous Region, China, 530021
      • The First Affiliated Hospital of Guangxi Medical University
  • Hebei
    • Shijiazhuang, Hebei, China, 050010
      • The Fourth Hospital of Hebei Medical University
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150000
      • Affiliated Tumor Hospital of Harbin Medical University
  • Henan
    • Anyang, Henan, China, 455000
      • AnYang Tumor Hospital
  • Hubei
    • Wuhan, Hubei, China, 430061
      • Zhongnan Hospital of Wuhan University
  • Hunan
    • Changsha, Hunan, China, 410013
      • Hunan Cancer Hospital
  • Jiangsu
    • Nantong, Jiangsu, China, 226000
      • Nantong Tumor Hospital
  • Jilin
    • Changchun, Jilin, China, 130021
      • The first hospital of jilin university
    • Yanji, Jilin, China, 133000
      • Yanbian University Hospital
  • Liaoning
    • Shenyang, Liaoning, China, 110011
      • The First Hospital of China Medical University
    • Shenyang, Liaoning, China, 110042
      • Liaoning Cancer Hospital & Institute
  • Shandong
    • Jinan, Shandong, China, 250000
      • Qilu Hospital of Shandong University
  • Shanxi
    • Taiyuan, Shanxi, China, 030013
      • Shanxi Cancer Hospital
    • Xi'an, Shanxi, China, 710068
      • Shanxi Provincial People's Hospital
    • Xi'an, Shanxi, China, 710061
      • The First Affiliated Hospital of Xi'an Jiaotong University
    • Xi'an, Shanxi, China, 710032
      • The Second Affiliated Hospital of PLA Airforce Military Medical University
  • Sichuan
    • Neijiang, Sichuan, China, 641100
      • The Second People's Hospital of Neijiang
  • Tianjin
    • Tianjin, Tianjin, China, 300060
      • Tianjin Cancer Hospital
  • Xinjiang
    • Urumqi, Xinjiang, China, 830000
      • Xinjiang Uiger Municipal People's Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Zhejiang Cancer Hospital
    • Hangzhou, Zhejiang, China, 310052
      • The Second Affiliated Hospital of Zhejiang University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TQB2450 + Anlotinib; 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; 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.; Drug: Anlotinib; a multi-target receptor tyrosine kinase inhibitor.
Active Comparator: Paclitaxel for injection (albumin bound); 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); a anti-microtubule drug.

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
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
Disease control rate（DCR）	Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).	up to 96 weeks

Collaborators and Investigators

• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2020
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: May 24, 2020
• First Submitted That Met QC Criteria: May 24, 2020
• First Posted (Actual): May 28, 2020

Study Record Updates

• Last Update Posted (Actual): May 28, 2020
• Last Update Submitted That Met QC Criteria: May 24, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Triple Negative Breast Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel
• Other Study ID Numbers: TQB2450-III-06

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No