Dynamic Observational Study With PET of 68Ga-HER2-affibody in Anti-HER2 Treatment
- Conditions
- Breast Cancer
- Interventions
- Registration Number
- NCT04769050
- Lead Sponsor
- Fudan University
- 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 disease progression. Patients of first-line received docetaxel combined with trastuzumab±pertuzumab regimen, and patients of second-line received T-DM1 monotherapy or capecitabine combined with pyrrotinib regimen.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 50
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Subjects voluntarily joined the study, signed informed consent, and had good compliance.
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Female patients aged over 18 years (including cutoff value).
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an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
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Patients with HER2 positive recurrent or metastatic breast cancer confirmed by histopathology.
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At least one extracranial measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1.
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Previously received no more than 1 prior lines of systemic chemotherapy for metastatic breast cancer
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Life expectancy ≥ 12 weeks.
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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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description First-line patients Docetaxel combined with Trastuzumab±Pertuzumab First-line treatment of HER2-positive metastatic breast cancer patients Second-line patients T-DM1 or Capecitabine combined with Pyrotinib regimen. Second-line treatment of HER2-positive metastatic breast cancer patients
- Primary Outcome Measures
Name Time Method The correlation between the change of HER2-PET at baseline and after 2 courses of treatment and ORR. 2 year The correlation between the percent change in standardized uptake value (SUV) on 68Ga-Affibody HER-2 Imaging PET at baseline and after 2 courses of treatment and objective response rate(ORR).
- Secondary Outcome Measures
Name Time Method The correlation between the change of HER2-PET at baseline and after 2 courses of treatment and PFS 2 year The correlation between the percent change in SUV on 68Ga-Affibody HER-2 Imaging PET at baseline and after 2 courses of treatment and progression-free survival(PFS).
The correlation between baseline HER2 expression and ORR, PFS 2 year The correlation between the baseline SUVmax on 68Ga-Affibody HER-2 Imaging PET and ORR, PFS.
The correlation between heterogeneity of baseline HER2 expression and ORR, PFS 2 year The correlation between heterogeneity of the baseline SUVmax on 68Ga-Affibody HER-2 Imaging PET and ORR, PFS.
To explore the condition of HER2-PET when PD. 2 year To detection the change in SUVmax on 68Ga-Affibody HER-2 Imaging PET when progressive disease(PD).
Trial Locations
- Locations (1)
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, Shanghai, China