The Efficacy and Safety of BAT8001 Injection for the Treatment of HER2-positive Advanced Breast Cancer
HER2-positive Advanced Breast Cancer
About this trial
This is an interventional treatment trial for HER2-positive Advanced Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- The First Affiliated Hospital of Bengbu Medical College
- Anhui Provincial Hospital
- Beijing Hospital
- Beijing Shijitan Hospital
- Peking union medical college hospital
- Chinese PLA General Hospital
- Chongqing Cancer Hospital
- The First Affiliated Hospital of Xiamen University
- Foshan City No. 1 People's Hospital
- Cancer Center of Guangzhou Medical University
- Sun Yat-sen Memorial Hospital. SYSU
- Sun Yat-sen University Cancer Center
- Peking University Shenzhen Hospital
- Shenzhen People's Hospital
- The First Affiliated Hospital of Guangdong Medical University
- The Fifth Affiliated Hospital Sun Yat-sen University
- Liuzhou workers hospital
- The First Affiliated Hospital of Hainan Medical College
- Harbin Medical University Cancer Hospital
- The First Affiliated Hospital of Henan University of science and technology
- The First Affiliated Hospital of Xixiang Medical College
- Hubei Cancer Hospital
- Tongji Hospital of Tongji Medical College of HUST
- Zhongnan Hospital of Wuhan University
- Yichang Central Hospital
- Hunan Cancer Hospital
- Xiangya Hospital Central South University
- Jiangsu Cancer Hospital
- Affiliated Hospital of Jiangnan University
- Yancheng City No. 1 People's Hospital
- Jiangxi Cancer Hospital
- The Third Hospital of Nanchang
- Jilin Cancer Hospital
- The First Bethune Hospital of Jilin University
- Jinzhou Central Hospital
- Liaoning Cancer Hospital
- General Hospital of Ningxia Medical University
- Shandong Cancer Hospital
- Linyi Cancer Hospital
- Weifang People's Hospital
- Fudan University Shanghai Cancer Hospital
- Shanghai General Hospital
- Shanghai Sixth People's Hospital
- The Second Hospital of Anhui Medical University
- Shanxi Cancer Hospital
- The First Affiliated Hospital of Xi'an Jiaotong University
- West China Hospital of Sichuan University
- Yunnan Cancer Hospital
- The Second Affiliated Hospital of Zhejiang University School of Medicine
- Zhejiang Cancer Hospital
- Taizhou Hispotal of Zhejiang Province
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
BAT8001 for injection
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 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.
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.