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New treatment option for Anatomic Stage IV Breast Cancer AJCC v8
Official title An Investigational Scan (64Cu-DOTA-Trastuzumab PET/MRI) in Imaging Patients With HER2+ Breast Cancer With Brain Metastasis
ClinicalTrials.gov ID: NCT05376878
What this study is testing
What is Trastuzumab?
Trastuzumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for anatomic stage iv breast cancer ajcc v8.
Also referred to as ABP 980, ALT02.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This clinical trial examines an investigational scan (64Cu-DOTA-trastuzumab positron emission tomography [PET]/magnetic resonance imaging [MRI]) in imaging patients with HER2+ breast cancer that has spread to the brain (brain metastasis). Diagnostic procedures, such as 64Cu-DOTA-trastuzumab PET/MRI, may help find HER2+ breast cancer that has spread to the brain and determine whether cancer in the brain takes up trastuzumab, which may predict for response to trastuzumab deruxtecan (the standard of care chemotherapy).
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Documented informed consent of the participant and/or legally authorized representative
- Women with documented metastatic HER2 positive breast cancer (American Society of Clinical Oncology [ASCO] College of American Pathologist [CAP]...
- Age \> 18 years
- Eastern Cooperative Oncology Group (ECOG) 0-2
- Patients with leptomeningeal disease will be considered eligible
You likely can't join if
- Need for immediate local intervention for brain metastases
- Noninfectious interstitial lung disease or pneumonitis requiring glucocorticoids
- Clinically significant corneal disease
- Myocardial infarction \< 6 months before, congestive heart failure (CHF), unstable angina, or serious cardiac arrhythmia
See the full eligibility criteria
- Documented informed consent of the participant and/or legally authorized representative
- Women with documented metastatic HER2 positive breast cancer (American Society of Clinical Oncology [ASCO] College of American Pathologist [CAP] guidelines) who have brain metastases
- Age \> 18 years
- Eastern Cooperative Oncology Group (ECOG) 0-2
- Patients with leptomeningeal disease will be considered eligible
- Planned therapy with fam-trastuzumab deruxtecan
- Left ventricular ejection fraction (LVEF) \> 50%
- Absolute neutrophil count (ANC) \> 1.5 x 10\^9/L
- Platelets \> 100 x 10\^9/L
- Hemoglobin \> 9 g/dL
- Total (T.) bilirubin \< 3 x upper limit of normal (ULN)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 5 x ULN
- Creatinine clearance \> 30 ml/min (by Cockcroft-Gault formula)
- Activated partial thromboplastin time (aPTT) \< 1.5 x ULN
- Prior therapy for central nervous system (CNS) disease is allowed, but at least 1 lesion \> 1.5 cm is evident on MRI
- Need for immediate local intervention for brain metastases
- Noninfectious interstitial lung disease or pneumonitis requiring glucocorticoids
- Clinically significant corneal disease
- Myocardial infarction \< 6 months before, congestive heart failure (CHF), unstable angina, or serious cardiac arrhythmia
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.