Dynamic Observational Study With PET of 68Ga-HER2-affibody in Anti-HER2 Treatment
Study Details
Study Description
Brief Summary
Dynamic observationaL study with PET of 68Ga-HER2-affibody in anti-HER2 treatment
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| First-line patients First-line treatment of HER2-positive metastatic breast cancer patients |
Drug: Docetaxel combined with Trastuzumab±Pertuzumab
Docetaxel, 75 mg/m2 ivgtt d1 q3w Trastuzumab, 6 mg/kg(8 mg/kg for initial dose) ivgtt d1 q3w Pertuzumab, 420mg(840mg for initial dose) ivgtt d1 q3w
|
| Second-line patients Second-line treatment of HER2-positive metastatic breast cancer patients |
Drug: T-DM1 or Capecitabine combined with Pyrotinib regimen.
T-DM1, 3.6mg/kg(8 mg/kg for initial dose) ivgtt d1 q3w Capecitabine, 1250 mg/m2 bid po d1-14 q3w Pyrotinib, 400mg po daily (continuously)
|
Outcome Measures
Primary Outcome Measures
- 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
- 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).
Eligibility Criteria
Criteria
Inclusion Criteria:
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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):
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Neutrophils ≥ 1.5×10^9/L
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Platelets ≥ 75×10^9/L
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Hemoglobin ≥ 80g/L
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Total bilirubin≤ 1.5 × the upper limit of normal (ULN)
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ALT and AST ≤ 3 × ULN
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BUN and Cr ≤ 1.5 × ULN
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Left ventricular ejection fraction (LVEF) ≥ 50%
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QTcF(Fridericia correction) ≤ 470 ms
Exclusion Criteria:
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The subject has untreated central nervous system (CNS) metastases.
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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.
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Received systemic therapy such as chemotherapy, molecular targeted therapyment;received endocrine therapy within 2 weeks before enrollment.
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Patients with other malignant tumors within 3 years or at the sametime(except for cured skin basal cell carcinoma and cervical carcinomain situ).
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Have undergone major surgical procedures or significant trauma within 4 weeks prior to randomization, or are expected to undergo major surgery.
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Pregnant women, lactating female, or women of childbearing age who are unwilling to take effective contraceptive measures.
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Have a history of allergies to the drug components of this regimen.
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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).
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History of immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency disease, history of organ transplantation.
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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.
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Female patients who are pregnancy, lactation or women who are ofchildbearing potential tested positive in baseline pregnancy test.
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Childbearing female who refuse to accept any contraception practice.
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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.).
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History of neurological or psychiatric disorders, including epilepsy or dementia.
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fudan University Shanghai Cancer Center | Shanghai | Shanghai | China |
Sponsors and Collaborators
- Fudan University
Investigators
- Principal Investigator: Xichun Hu, MD, PhD, Fudan University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DOLPHIN