The Efficacy and Safety of BAT8001 Injection for the Treatment of HER2-positive Advanced Breast Cancer
NCT ID: NCT04185649
Last Updated: 2019-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
410 participants
INTERVENTIONAL
2018-07-01
2021-12-31
Brief Summary
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Detailed Description
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Eligible subjects will be randomized to the experimental or control group in a 1:1 ratio and stratified by the number of HER2-positive advanced/metastatic breast cancer treatment regimens (0, 1 VS \> 1) and lesion site (organ VS non-organ).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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BAT8001 for injection
Participants with HER2-positive, unresectable LABC or MBC who have experienced disease progression after treatment with trastuzumab and a taxane will be treated with trastuzumab emtansine. Participants may continue to receive study treatment until disease progression (as assessed by the investigator), unmanageable toxicity, or study termination by the Sponsor.
BAT8001 for injection
3.6 mg/kg, q3w, administered intravenously on day 1 of each treatment cycle, 21 days/treatment cycle.
Control (lapatinib + capecitabine)
Participants with HER2-positive, unresectable LABC or MBC who have experienced disease progression after treatment with trastuzumab and a taxane will be treated with lapatinib plus capecitabine. Participants may continue to receive study treatment until disease progression (as assessed by the investigator), unmanageable toxicity, or study termination by the Sponsor.
Lapatinib
Lapatinib 1250 mg was administered orally once per day of each 21-day cycle.
Capecitabine
Capecitabine 1000 milligrams per square meter (mg/m\^2) was administered orally twice daily on Days 1-14 of each 21-day cycle.
Interventions
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BAT8001 for injection
3.6 mg/kg, q3w, administered intravenously on day 1 of each treatment cycle, 21 days/treatment cycle.
Lapatinib
Lapatinib 1250 mg was administered orally once per day of each 21-day cycle.
Capecitabine
Capecitabine 1000 milligrams per square meter (mg/m\^2) was administered orally twice daily on Days 1-14 of each 21-day cycle.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. HER2-positive (defined as: IHC 3+ or FISH+) confirmed by the central laboratory of this study.
3. Histologically and/or cytologically confirmed invasive breast cancer, including unresectable locally advanced breast cancer (LABC) or metastatic breast cancer (MBC).
4. LABC or MBC that has progressed during or after treatment, or during or within 12 month following adjuvant therapy as confirmed by imaging.
5. Previously received adjuvant therapy, or locally advanced/metastatic breast cancer treatment regimen that included taxanes and trastuzumab (including approved biosimilars) as monotherapy or combination therapy。
6. At least one measurable lesion or a single metastatic tumor in the bone as per the Response Evaluation Criteria in Solid Tumor (RECIST) 1.1.
7. A score of 0-1 for performance status as per the Eastern Cooperative Oncology Group (ECOG) scale.
8. Expected survival ≥ 3 months.
9. Left ventricular ejection fraction (LVEF) ≥ 50%.
10. If anthracyclines are used, the cumulative dose must meet the following criteria: the cumulative dose must not exceed the equivalent dose of doxorubicin 500 mg/m2.
11. Women of childbearing age or fertile male subjects must agree to use oral, implanted, or injectable hormone contraceptives as well as one or two forms of non-hormonal contraceptive measures during the study period and until 6 months after the end of the study.
12. Blood pregnancy test must indicate non-pregnant for all women of childbearing potential and those who do not meet the definition of postmenopause.
Exclusion Criteria
2. History of other malignant tumors within the past 5 years, but does not include properly treated cervical carcinoma in situ, non-melanoma skin cancer, stage 1 uterine cancer, or other tumors with good prognosis.
3. Received treatment with a cancer drug or investigational drug within 21 days from the first dose of the study drug, except for hormone therapy..
4. Received radiation therapy within 14 days prior to the first test drug administration of this study; or subject has not recovered from the acute toxicity of radiation therapy prior to the first test drug administration of this study.
5. Brain metastasis that is symptomatic or requires treatment to control symptoms within 30 days before randomization.
6. Subjects who must receive the first test drug administration within less than 14 days following the completion of radiation therapy for symptomatic brain metastasis.
7. Currently experiences moderate or severe dyspnea at rest caused by advanced malignancy or other complications or severe primary lung diseases, or currently requires continuous oxygen therapy, or subject currently suffers from interstitial lung disease (ILD) or pneumonia/pneumonitis.
8. History of myocardial infarction or unstable angina within 6 months prior to first test drug administration.
9. Previous history of LVEF falling below 40%; or presence of symptomatic congestive heart failure (CHF) during trastuzumab (including other analogues) treatment.
10. Symptomatic congestive heart failure (CHF; New York Heart Association \[NYHA\] Class II-IV); Severe arrhythmias requiring treatment.
11. Presence of severe and uncontrollable systemic diseases (e.g. clinically significant cardiovascular, lung or metabolic diseases).
12. Patients who currently require coumarin derivative-based anticoagulation therapy such as warfarin and phenprocoumon.
13. Presence of diseases that may affect intestinal absorption, including malabsorption syndrome, stomach and small bowel resection, and ulcerative colitis.
14. Intolerance (grade 3-4 infusion reactions) or allergy to trastuzumab (and other analogues) or mouse proteins or any ingredient of the medication.
18 Years
75 Years
ALL
No
Sponsors
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Bio-Thera Solutions
INDUSTRY
Responsible Party
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Principal Investigators
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Shusen Wang, M.D.
Role: PRINCIPAL_INVESTIGATOR
Sun Yat-sen University
Locations
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The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
Anhui Provincial Hospital
Hefei, Anhui, China
Beijing Hospital
Beijing, Beijing Municipality, China
Beijing Shijitan Hospital
Beijing, Beijing Municipality, China
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Peking union medical college hospital
Beijing, Beijing Municipality, China
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Foshan City No. 1 People's Hospital
Foshan, Guangdong, China
Cancer Center of Guangzhou Medical University
Guangzhou, Guangdong, China
Sun Yat-sen Memorial Hospital. SYSU
Guangzhou, Guangdong, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China
Shenzhen People's Hospital
Shenzhen, Guangdong, China
The First Affiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong, China
The Fifth Affiliated Hospital Sun Yat-sen University
Zhuhai, Guangdong, China
Liuzhou workers hospital
Liuzhou, Guangxi, China
The First Affiliated Hospital of Hainan Medical College
Haikou, Hainan, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
The First Affiliated Hospital of Henan University of science and technology
Luoyang, Henan, China
The First Affiliated Hospital of Xixiang Medical College
Xinxiang, Henan, China
Hubei Cancer Hospital
Wuhan, Hubei, China
Tongji Hospital of Tongji Medical College of HUST
Wuhan, Hubei, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
Yichang Central Hospital
Yichang, Hubei, China
Hunan Cancer Hospital
Changsha, Hunan, China
Xiangya Hospital Central South University
Changsha, Hunan, China
Jiangsu Cancer Hospital
Nanning, Jiangsu, China
Affiliated Hospital of Jiangnan University
Wuxi, Jiangsu, China
Yancheng City No. 1 People's Hospital
Yancheng, Jiangsu, China
Jiangxi Cancer Hospital
Nanchang, Jiangxi, China
The Third Hospital of Nanchang
Nanchang, Jiangxi, China
Jilin Cancer Hospital
Changchun, Jilin, China
The First Bethune Hospital of Jilin University
Changchun, Jilin, China
Jinzhou Central Hospital
Jinzhou, Liaoning, China
Liaoning Cancer Hospital
Shenyang, Liaoning, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China
Shandong Cancer Hospital
Jinan, Shandong, China
Linyi Cancer Hospital
Linyi, Shandong, China
Weifang People's Hospital
Weifang, Shandong, China
Fudan University Shanghai Cancer Hospital
Shanghai, Shanghai Municipality, China
Shanghai General Hospital
Shanghai, Shanghai Municipality, China
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, China
The Second Hospital of Anhui Medical University
Shanghai, Shanghai Municipality, China
Shanxi Cancer Hospital
Xi’an, Shanxi, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Yunnan Cancer Hospital
Kunming, Yunnan, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Taizhou Hispotal of Zhejiang Province
Taizhou, Zhejiang, China
Countries
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Other Identifiers
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BAT-8001-002-CR
Identifier Type: -
Identifier Source: org_study_id
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