Using FDG-PET/CT to Assess Response of Bone-Dominant Metastatic Breast Cancer, FEATURE Study (NCT04316117) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Using FDG-PET/CT to Assess Response of Bone-Dominant Metastatic Breast Cancer, FEATURE Study
United States, Ireland, Puerto Rico138 participantsStarted 2020-09-15
Plain-language summary
This phase II trial studies how well FDG-PET/CT works in assessing the response of patients with breast cancer that has spread to the bones or mostly to the bones (bone-dominant metastatic breast cancer). Diagnostic procedures, such as FDG-PET/CT, may work better in measuring breast cancer activity before and after treatment compared to other standard imaging tests.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients must have an Eastern Cooperative Oncology Group (ECOG) performance (performance status \[PS\]) =\< 2
* Patients with histologically confirmed metastatic breast cancer by local assessment that is hormone receptor positive by American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines and with known HER2 status
* Patients must have radiologically confirmed bone-dominant (BD) or bone-only (BO) disease
* BD defined as disease involving bone with or without limited measurable metastases by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, with \>= 1 non-irradiated bone metastasis on bone scintigraphy
* NOTE: Limited measurable metastases includes lymph nodes and the soft tissue components of lytic or mixed lytic/blastic bone metastases. Any number of lymph nodes \< 3 cm and up to 2 lymph nodes \> 3 cm will be allowed. Up to 5 measurable soft tissue components of lytic or mixed mytic/blastic bone metastases will be allowed
* BO defined as detectable disease confined within the bone (any site, any number of lesions). Diagnosis requires abnormalities identified by imaging (bone scan, CT +/- PET +/- magnetic resonance imaging \[MRI\]) with no other sites of metastases identified and with \>= 1 non-irradiated bone metastasis on bone scintigraphy
* Patients must have no contraindication to FDG-PET imaging
* Patients must have one of the following systemic therapies:
* Plan to receive either 1st or 2…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 2 trial that's no longer actively recruiting, is there any way I could still be considered for enrollment, or would my doctor be able to access the imaging approach being studied through another pathway?
2This study is testing whether FDG-PET/CT scans can predict how long someone with bone-dominant metastatic breast cancer stays progression-free — how would using this type of imaging change the way my treatment response would be monitored compared to what's done routinely today?
3Because bone metastases can be hard to measure with standard scans, could my doctor explain what limitations exist with conventional imaging for my situation, and whether FDG-PET/CT is already being used at our center for cases like mine?
4Since the trial is focused on hormone receptor-positive metastatic breast cancer, how would my specific hormone receptor status and current or planned treatment factor into whether this imaging approach would even be relevant to my care?
5Given that this is a Phase 2 study measuring how well a scanning tool predicts survival outcomes rather than testing a new drug, what does my doctor think the results could mean for how patients like me are monitored in the future — and should that influence any decisions I make now?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Performance of fludeoxyglucose F-18 (FDG)-positron emission tomography (PET)/computed tomography (CT) response criteria as a binary predictor of progression-free survival (PFS)