Status:
UNKNOWN
Dynamic Observational Study With PET of 68Ga-HER2-affibody in Anti-HER2 Treatment
Lead Sponsor:
Fudan University
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-75 years
Brief Summary
Dynamic observationaL study with PET of 68Ga-HER2-affibody in anti-HER2 treatment
Detailed Description
Participants participated in the screening period visit, and received HER2-PET and 18 F-FDG PET/CT examinations before receiving tumor treatment, after receiving 2 cycles of chemotherapy, and after di...
Eligibility Criteria
Inclusion
- Subjects voluntarily joined the study, signed informed consent, and had good compliance.
- Female patients aged over 18 years (including cutoff value).
- an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- Patients with HER2 positive recurrent or metastatic breast cancer confirmed by histopathology.
- At least one extracranial measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1.
- Previously received no more than 1 prior lines of systemic chemotherapy for metastatic breast cancer
- Life expectancy ≥ 12 weeks.
- Adequate function of major organs meets the following requirements (no blood components and cell growth factors have been used within 14 days before randomization):
- Neutrophils ≥ 1.5×10\^9/L
- Platelets ≥ 75×10\^9/L
- Hemoglobin ≥ 80g/L
- Total bilirubin≤ 1.5 × the upper limit of normal (ULN)
- ALT and AST ≤ 3 × ULN
- BUN and Cr ≤ 1.5 × ULN
- Left ventricular ejection fraction (LVEF) ≥ 50%
- QTcF(Fridericia correction) ≤ 470 ms
Exclusion
- The subject has untreated central nervous system (CNS) metastases.
- Patients who have undergone systemic, radical brain or meningeal metastasis (radiotherapy or surgery), but have been confirmed to have been stable for at least 4 weeks, and who have stopped systemic hormonal therapy for more than 2 weeks without clinical symptoms can be included.
- Received systemic therapy such as chemotherapy, molecular targeted therapyment;received endocrine therapy within 2 weeks before enrollment.
- Patients with other malignant tumors within 3 years or at the sametime(except for cured skin basal cell carcinoma and cervical carcinomain situ).
- Have undergone major surgical procedures or significant trauma within 4 weeks prior to randomization, or are expected to undergo major surgery.
- Pregnant women, lactating female, or women of childbearing age who are unwilling to take effective contraceptive measures.
- Have a history of allergies to the drug components of this regimen.
- Patients with active HBV and HCV infection; stable hepatitis B after drug treatment (HBV virus copy number is higher than the upper limit of reference value) and cured hepatitis C patients (HCV virus copy number exceeds the lower limit of detection method).
- History of immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency disease, history of organ transplantation.
- History of cardiac dysfunction, include(1)angina (2)clinical significant arrythmia or require drug intervention (3)myocardial infarction (4)heart failure (5) other cardiac dysfunction (judged by the physician); any cardiac or nephric abnormal ≥ grade 2 found in screening.
- Female patients who are pregnancy, lactation or women who are ofchildbearing potential tested positive in baseline pregnancy test.
- Childbearing female who refuse to accept any contraception practice.
- Determined by the physician, any serious coexisting disease might be harmful to the patient's safety or avoid the patients from accomplishing the treatment(e.g serious hypertension, diabetes, thyroid dysfunction,active infection etc.).
- History of neurological or psychiatric disorders, including epilepsy or dementia.
- Severe infections within 4 weeks prior to first dose (eg, intravenous infusion of antibiotics, antifungal or antiviral drugs according to clinical protocols), or unexplained fever (T \> 38.3 °C ) during screening or prior to first administration
Key Trial Info
Start Date :
February 18 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04769050
Start Date
February 18 2021
End Date
December 31 2023
Last Update
April 20 2022
Active Locations (1)
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1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China