The Efficacy and Safety of BAT8001 Injection for the Treatment of HER2-positive Advanced Breast Cancer
A Clinical Study Evaluating the Efficacy and Safety of BAT8001 Injection for the Treatment of HER2-positive Advanced Breast Cancer - A Multicenter, Randomized, Open-label, Positive-controlled, Superiority Phase III Clinical Trial in China
1 other identifier
interventional
410
1 country
51
Brief Summary
To evaluate the safety and efficacy of BAT8001 for the treatment of HER2-positive advanced breast cancer, using lapatinib in combination with capecitabine as the positive control drug.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2018
Typical duration for phase_3
51 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2018
CompletedFirst Submitted
Initial submission to the registry
December 1, 2019
CompletedFirst Posted
Study publicly available on registry
December 4, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedDecember 4, 2019
December 1, 2019
2.1 years
December 1, 2019
December 1, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Progression-free survival (PFS)
PFS is defined as the time from randomization to the first occurrence of disease progression as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) Version (v1.1), or death from any cause during the study, whichever occurs first.
Up to approximately 18 months
Secondary Outcomes (8)
Overall Survival (OS)
Up to approximately 30 months
Objective Response Rate (ORR)
Up to approximately 30 months
Duration of Response (DOR)
Up to approximately 30 months
Clinical Benefit Rate (CBR)
Up to approximately 30 months
Serum Concentration of BAT8001
Pre-dose and 15-30 minutes after dose on Day 1, Day 8, Day 15 of each 21-day cycle during Cycles 1-4 and at completion/early termination visit (up to approximately 30 months)
- +3 more secondary outcomes
Study Arms (2)
BAT8001 for injection
EXPERIMENTALParticipants 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.
Control (lapatinib + capecitabine)
ACTIVE COMPARATORParticipants 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.
Interventions
3.6 mg/kg, q3w, administered intravenously on day 1 of each treatment cycle, 21 days/treatment cycle.
Lapatinib 1250 mg was administered orally once per day of each 21-day cycle.
Capecitabine 1000 milligrams per square meter (mg/m\^2) was administered orally twice daily on Days 1-14 of each 21-day cycle.
Eligibility Criteria
You may qualify if:
- Patients are required to provide at least 10 unstained sections.
- HER2-positive (defined as: IHC 3+ or FISH+) confirmed by the central laboratory of this study.
- Histologically and/or cytologically confirmed invasive breast cancer, including unresectable locally advanced breast cancer (LABC) or metastatic breast cancer (MBC).
- LABC or MBC that has progressed during or after treatment, or during or within 12 month following adjuvant therapy as confirmed by imaging.
- 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。
- 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.
- A score of 0-1 for performance status as per the Eastern Cooperative Oncology Group (ECOG) scale.
- Expected survival ≥ 3 months.
- Left ventricular ejection fraction (LVEF) ≥ 50%.
- 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.
- 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.
- Blood pregnancy test must indicate non-pregnant for all women of childbearing potential and those who do not meet the definition of postmenopause.
You may not qualify if:
- Current presence of grade ≥ 2 peripheral neuropathy.
- 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.
- Received treatment with a cancer drug or investigational drug within 21 days from the first dose of the study drug, except for hormone therapy..
- 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.
- Brain metastasis that is symptomatic or requires treatment to control symptoms within 30 days before randomization.
- Subjects who must receive the first test drug administration within less than 14 days following the completion of radiation therapy for symptomatic brain metastasis.
- 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.
- History of myocardial infarction or unstable angina within 6 months prior to first test drug administration.
- Previous history of LVEF falling below 40%; or presence of symptomatic congestive heart failure (CHF) during trastuzumab (including other analogues) treatment.
- Symptomatic congestive heart failure (CHF; New York Heart Association \[NYHA\] Class II-IV); Severe arrhythmias requiring treatment.
- Presence of severe and uncontrollable systemic diseases (e.g. clinically significant cardiovascular, lung or metabolic diseases).
- Patients who currently require coumarin derivative-based anticoagulation therapy such as warfarin and phenprocoumon.
- Presence of diseases that may affect intestinal absorption, including malabsorption syndrome, stomach and small bowel resection, and ulcerative colitis.
- Intolerance (grade 3-4 infusion reactions) or allergy to trastuzumab (and other analogues) or mouse proteins or any ingredient of the medication.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (51)
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
Liuchow, 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
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shusen Wang, M.D.
Sun Yat-sen University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 1, 2019
First Posted
December 4, 2019
Study Start
July 1, 2018
Primary Completion
July 31, 2020
Study Completion
December 31, 2021
Last Updated
December 4, 2019
Record last verified: 2019-12
Data Sharing
- IPD Sharing
- Will not share