Breast Cancer Clinical Trial
Using FDG-PET/CT to Assess Response of Bone-Dominant Metastatic Breast Cancer, FEATURE Study
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.
Full Description
PRIMARY OBJECTIVE:
I. Evaluate the performance of fludeoxyglucose F-18 (FDG)-positron emission tomography (PET)/computed tomography (CT) response criteria (modified PET Response Criteria in Solid Tumors [PERCIST] complete, partial and stable metabolic disease versus progressive metabolic disease) as a binary predictor of progression-free survival (PFS) in patients with bone-dominant (BD) metastatic breast cancer (MBC) treated with systemic therapy.
SECONDARY OBJECTIVES:
I. Evaluate the ability of FDG-PET/CT modified PERCIST criteria (complete versus [vs] partial vs stable vs metabolic progression) to independently predict PFS in patients with BD MBC.
II. Evaluate the ability of FDG-PET/CT modified PERCIST criteria (complete, partial, and stable versus progressive metabolic disease) to predict time to skeletal related events (SRE) and overall survival (OS) in patients with BD MBC.
III. Evaluate the ability of FDG-PET/CT metrics (percent change in peak standardized uptake value corrected for lean body mass (SULpeak), maximum standardized uptake value corrected for body weight (SUVmax) as continuous variables in index or up to 5 lesions) to predict PFS, time to SRE and OS in patients with BD MBC.
IV. Assess the utility of FDG-PET/CT to identify disease progression by identification of new lesions not identified by standard CT and bone scan.
EXPLORATORY OBJECTIVES:
I. Define criteria for selection of FDG-avid bone lesions for analysis based on thresholds for SULpeak or SUVmax.
II. In collaboration with National Cancer Institute (NCI) Quantitative Imaging Network (QIN), explore alternative methods for measuring metabolic response with FDG-PET/CT (e.g., total lesion glycolysis, quantitative total bone imaging, MD Anderson bone criteria, and radiomics) to predict clinical endpoints in patients with BD MBC.
III. Evaluate automated image analysis of FDG-PET/CT by AutoPERCIST.
OUTLINE:
Patients receive FDG intravenously (IV) and undergo PET/CT scan over 15-30 minutes at baseline (within 21 days before start of standard systemic treatment) and at 12 weeks after start of standard systemic treatment in the absence of unacceptable toxicity.
After completion of study, patients are followed up periodically for up to 3 years after study registration.
Eligibility Criteria
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 2nd line endocrine therapy for metastatic breast cancer. Endocrine therapy may include selective estrogen receptor modulators (SERMs), aromatase inhibitors, and/or fulvestrant that may be combined with Food and Drug Administration (FDA)-approved biologic agents (palbociclib, ribociclib, abemaciclib, everolimus, alpelisib)
Chemotherapy per National Comprehensive Cancer Network (NCCN) or institutional standard. Use of colony stimulating growth factor must be suspended for >= 14 days prior to FDG-PET/CT scans at baseline and 12-weeks
Plan to receive HER2-targeted therapy per ASCO, NCCN, and/or institutional guidelines as indicated for patients with HER2 positive disease. When HER2-targeted therapy is used with chemotherapy, use of colony stimulating growth factors is NOT expected or should be suspended for a minimum of 2 weeks, but preferably for at least 3 weeks prior to the required FDG-PET/CT scan time points
The use of bone-stabilizing agents (bisphosphonates or denosumab) is permitted
Patient must meet institutional guidelines for renal function for MRI and CT scanning
Patient's life expectancy must be estimated at >= 24 weeks
The patient is participating in the trial at an institution which has agreed to perform the imaging research studies, completed the ECOG-American College of Radiology Imaging Network (ACRIN) defined PET/CT scanner qualification procedures and received ECOG-ACRIN PET/CT scanner approval
Patients must complete the baseline (T0) FDG-PET within 28 days prior to registration or within 28 days after registration
For patients completing the baseline (T0) FDG-PET AFTER registration all parameters must be met
For patients who completed the baseline (T0) FDG-PET prior to registration the following tests are exempt:
Pregnancy testing documentation prior to FDG-PET (T0 time point)
Exclusion Criteria:
Patients with RECIST 1.1 measurable lesions in viscera, active central nervous system (CNS), leptomeningeal carcinomatous or pleural or peritoneal disease will not be eligible. Patients with prior CNS metastases treated with radiation or resection and without evidence of clinical or radiographic progression within 28 days of registration are eligible
Patients who have received greater than 3 lines of cytotoxic chemotherapy for metastatic breast cancer are not eligible
Patients currently participating in or have participated in a study of an investigational agent or using an investigational device within 3 weeks of study registration are not eligible
Patients with known additional malignancy that is progressing or requires active treatment are not eligible. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy
Women must not be pregnant because FDG is a radiopharmaceutical with the potential for teratogenic effects and PET/CT involves additional radiation exposure. In addition, because of radiation exposure to a nursing infant from FDG, women who are breastfeeding are also excluded from this study. All females of childbearing potential must have a blood test or urine study within 7 days prior to FDG-PET/CT to rule out pregnancy. Patients are excluded from this if baseline FDG-PET/CT scan met study parameters and was completed within 28 days of study registration
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There are 73 Locations for this study
Birmingham Alabama, 35233, United States More Info
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Los Angeles California, 90033, United States More Info
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Los Angeles California, 90033, United States More Info
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Sacramento California, 95817, United States
San Francisco California, 94158, United States More Info
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Truckee California, 96161, United States More Info
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Dover Delaware, 19901, United States More Info
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Aventura Florida, 33180, United States More Info
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Atlanta Georgia, 30303, United States More Info
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Atlanta Georgia, 30308, United States More Info
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Atlanta Georgia, 30322, United States More Info
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Atlanta Georgia, 30342, United States More Info
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'Aiea Hawaii, 96701, United States More Info
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'Aiea Hawaii, 96701, United States
Honolulu Hawaii, 96813, United States More Info
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Honolulu Hawaii, 96813, United States More Info
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Honolulu Hawaii, 96813, United States More Info
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Honolulu Hawaii, 96813, United States
Honolulu Hawaii, 96813, United States More Info
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Honolulu Hawaii, 96817, United States More Info
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Honolulu Hawaii, 96817, United States More Info
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Honolulu Hawaii, 96826, United States More Info
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Lihue Hawaii, 96766, United States More Info
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Boise Idaho, 83706, United States More Info
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Caldwell Idaho, 83605, United States More Info
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Nampa Idaho, 83686, United States More Info
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Chicago Illinois, 60611, United States More Info
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Danville Illinois, 61832, United States More Info
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Decatur Illinois, 62526, United States More Info
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Decatur Illinois, 62526, United States More Info
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DeKalb Illinois, 60115, United States More Info
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Effingham Illinois, 62401, United States More Info
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Geneva Illinois, 60134, United States More Info
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Mattoon Illinois, 61938, United States More Info
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Urbana Illinois, 61801, United States More Info
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Urbana Illinois, 61801, United States More Info
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Warrenville Illinois, 60555, United States More Info
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Louisville Kentucky, 40202, United States
Cumberland Maryland, 21502, United States More Info
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Boston Massachusetts, 02215, United States More Info
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Detroit Michigan, 48201, United States More Info
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Warren Michigan, 48093, United States
Creve Coeur Missouri, 63141, United States More Info
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Saint Louis Missouri, 63110, United States More Info
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Saint Louis Missouri, 63129, United States More Info
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Saint Louis Missouri, 63136, United States More Info
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Saint Peters Missouri, 63376, United States More Info
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Springfield Missouri, 65807, United States More Info
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Camden New Jersey, 08103, United States More Info
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Summit New Jersey, 07902, United States More Info
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Albuquerque New Mexico, 87102, United States More Info
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New York New York, 10065, United States More Info
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Columbus Ohio, 43210, United States More Info
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Oklahoma City Oklahoma, 73104, United States More Info
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Portland Oregon, 97239, United States More Info
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Bryn Mawr Pennsylvania, 19010, United States More Info
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Danville Pennsylvania, 17822, United States
East Norriton Pennsylvania, 19401, United States
Media Pennsylvania, 19063, United States More Info
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Paoli Pennsylvania, 19301, United States More Info
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Philadelphia Pennsylvania, 19111, United States More Info
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Wilkes-Barre Pennsylvania, 18711, United States More Info
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Wynnewood Pennsylvania, 19096, United States More Info
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Providence Rhode Island, 02903, United States More Info
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Charleston South Carolina, 29425, United States More Info
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Gaffney South Carolina, 29341, United States More Info
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Greer South Carolina, 29651, United States More Info
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Spartanburg South Carolina, 29303, United States More Info
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Union South Carolina, 29379, United States More Info
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Houston Texas, 77030, United States
San Antonio Texas, 78229, United States
Salt Lake City Utah, 84112, United States More Info
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Seattle Washington, 98109, United States More Info
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Seattle Washington, 98109, United States More Info
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Seattle Washington, 98195, United States More Info
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Eau Claire Wisconsin, 54701, United States More Info
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Madison Wisconsin, 53792, United States More Info
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Marshfield Wisconsin, 54449, United States More Info
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Minocqua Wisconsin, 54548, United States More Info
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Rice Lake Wisconsin, 54868, United States More Info
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Stevens Point Wisconsin, 54482, United States More Info
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Waukesha Wisconsin, 53188, United States More Info
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Weston Wisconsin, 54476, United States More Info
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