Triple Negative Breast CancerPhase 3NCT04405505
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 Phase 3 study testing TQB2450, Anlotinib and Paclitaxel for Injection (albumin bound) in people with Triple Negative Breast Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 30 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Triple Negative Breast Cancer
- What is being tested?
- TQB2450, Anlotinib and Paclitaxel for Injection (albumin bound)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 332 participants
- Where
- 30 sitesChina
- Study dates
- 1 Jun 2020to 1 Jul 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
China30 sites
AnYang Tumor Hospital
Anyang, Henan, 455000
Jing Sun
Jing Sun
Chinese Academy of Medical Sciencesand Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100032
Hongyan Ying, Doctor, yinghy15@163.com
Hongyan Ying, Doctor
Beijing Shijitan Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, 100038
Jun Ren, Doctor, jun.ren@duke.edu
Jun Ren, Doctor
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, 102218
Bin Luo, Doctor, luobin@mail.tsinghua.edu.cn
Bin Luo, Doctor
Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality
Binghe Xu, Doctor, 010-87788826, xubinghe@medmail.com.cn
Binghe Xu, Doctor
The First Hospital of Jilin University
Changchun, Jilin, 130021
Wei Li, Doctor, jdyylw@163.com
Wei Li, Doctor
Hunan Cancer Hospital
Changsha, Hunan, 410013
Quchang Ouyang, Doctor, oyqc1969@126.com
Quchang Ouyang, Doctor
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, 400000
Xiaohua Zeng, Doctor, 1340110079@qq.com
Xiaohua Zeng, Doctor
The First Affilited Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400042
Lu Gan, Doctor, ganlu99@sina.com
Lu Gan, Doctor
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510030
Ning Liao, Doctor, drningliao@163.com
Ning Liao, Doctor
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Xiaojia Wang, Doctor, wxiaojia0803@163.com
Xiaojia Wang, Doctor
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310052
Fuming Qiu, Doctor, qiufuming@zju.edu.cn
Fuming Qiu, Doctor
Affiliated Tumor Hospital of Harbin Medical University
Harbin, Heilongjiang, 150000
Qingyuan Zhang, Doctor, sy86298276@163.com
Qingyuan Zhang, Doctor
The Fourth Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230022
Yunhong Xia, Doctor, yhxia@sina.com
Yunhong Xia, Doctor
Qilu Hospital of Shandong University
Jinan, Shandong, 250000
Xiuwen Wang, Doctor, wangxiuwen@csco.org.cn
Xiuwen Wang, Doctor
Guangxi Medical University Affiliated Tumor Hospital
Nanning, Guangxi, 530021
Wenxian Zhou, Doctor, 939935994@qq.com
Wenxian Zhou, Doctor
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021
Jincai Zhong, Master
Jincai Zhong, Master
Nantong Tumor Hospital
Nantong, Jiangsu, 226000
Bojian Ge, doctorge@126.com
Bojian Ge
The Second People's Hospital of Neijiang
Neijiang, Sichuan, 641100
Xujuan Wang, Master, 61132803@qq.com
Xujuan Wang, Master
The First Hospital of China Medical University
Shenyang, Liaoning, 110011
Yuee Teng, Doctor, 024-83282543, tengyuee517@yahoo.com.cn
Yuee Teng, Doctor
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, 110042
Tao Sun, Doctor, lnzlrxnsy@163.com
Tao Sun, Doctor
The fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050010
Cuizhi Geng, Doctor, gengcuizhi@hotmail.com
Cuizhi Geng, Doctor
Shanxi Cancer Hospital
Taiyuan, Shanxi, 030013
Fuguo Tian, Master, 2205473988@qq.com
Fuguo Tian, Master
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, 300060
Zhongsheng Tong
Zhongsheng Tong
Xinjiang Uiger Municipal People's Hospital
Ürümqi, Xinjiang, 830000
Pengcheng Su, Master, drsupengcheng@163.com
Pengcheng Su, Master
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430061
Yahua Zhong, Doctor, doctorzyh73@163.com
Yahua Zhong, Doctor
The Second Affiliated Hospital of PLA Airforce Military Medical University
Xi’an, Shanxi, 710032
Huadong Zhao, Doctor, zhaolujy@fmmu.edu.cn
Huadong Zhao, Doctor
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, 710061
Yu Ren, Doctor, renyyyyy@126.com
Yu Ren, Doctor
Shanxi Provincial People's Hospital
Xi’an, Shanxi, 710068
Yanbian University Hospital
Yanji, Jilin, 133000
Songnan Zhang, Doctor, zhangsn21@163.com
Songnan Zhang, Doctor
About this study
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)
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.
- Conditions
- Triple Negative Breast Cancer
- Being tested
- TQB2450, Anlotinib, Paclitaxel for Injection (albumin bound)
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQB2450Drug
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.
AnlotinibDrug
a multi-target receptor tyrosine kinase inhibitor.
Paclitaxel for Injection (albumin bound)Drug
a anti-microtubule drug.
| Study group | Role | What they receive |
|---|---|---|
| TQB2450 + Anlotinib | Experimental | 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). Receives: Drug: TQB2450; Drug: Anlotinib |
| Paclitaxel for injection (albumin bound) | Active comparator | Paclitaxel for Injection (albumin bound) 100mg / m2 administered intravenously (IV) on Day 1, 8, 15 in 28-day cycle. Receives: Drug: Paclitaxel for Injection (albumin bound) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 96 weeks
Secondary outcomes (3)
Overall response rate (ORR)
Percentage of participants achieving complete response (CR) and partial response (PR).
Measured: up to 96 weeks
Disease control rate（DCR）
Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).
Measured: 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.
Measured: up to 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2020
- Study start1 Jun 2020 (estimated)
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple Negative Breast CancerStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 332 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04405505
- Sponsor's protocol ID
- TQB2450-III-06
- Status last verified
- May 2020
- First submitted
- 24 May 2020
- Last updated
- 28 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04405505
- Acronym / sponsor ID
- TQB2450-III-06
- Conditions
- Triple Negative Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 332 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2020 (estimated)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 28 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TQB2450 + Anlotinib | Experimental | Drug: TQB2450, Drug: AnlotinibTQB2450 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). |
| Paclitaxel for injection (albumin bound) | Active comparator | Drug: Paclitaxel for Injection (albumin bound)Paclitaxel for Injection (albumin bound) 100mg / m2 administered intravenously (IV) on Day 1, 8, 15 in 28-day cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TQB2450TQB2450 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 | TQB2450 + Anlotinib |
| Anlotiniba multi-target receptor tyrosine kinase inhibitor. | Drug | TQB2450 + Anlotinib |
| Paclitaxel for Injection (albumin bound)a anti-microtubule drug. | Drug | Paclitaxel for injection (albumin bound) |
Primary outcome
Progression free survival (PFS) evaluated by Independent Review Committee(IRC)
Time frame: up to 96 weeks
PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause, based on IRC.
3 secondary outcomes
Overall response rate (ORR)
Time frame: up to 96 weeks
Disease control rate（DCR）
Time frame: up to 96 weeks
Duration of Response (DOR)
Time frame: up to 96 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TQB2450, Anlotinib and Paclitaxel for Injection (albumin bound) in people with Triple Negative Breast Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 30 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Binghe Xu, Doctor (010-87788826, xubinghe@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (PFS) evaluated by Independent Review Committee(IRC) (time frame: up to 96 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2020.