Using FDG-PET/CT to Assess Response of Bone-Dominant Metastatic Breast Cancer, FEATURE Study
Anatomic Stage IV Breast Cancer AJCC v8, Hormone Receptor Positive Breast Carcinoma, Metastatic Breast Carcinoma
About this trial
This is an interventional diagnostic trial for Anatomic Stage IV Breast Cancer AJCC v8
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
Sites / Locations
- University of Alabama at Birmingham Cancer CenterRecruiting
- Los Angeles County-USC Medical Center
- USC / Norris Comprehensive Cancer Center
- University of California Davis Comprehensive Cancer Center
- UCSF Medical Center-Mission BayRecruiting
- Gene Upshaw Memorial Tahoe Forest Cancer Center
- Bayhealth Hospital Kent Campus
- GenesisCare USA - Aventura FP
- Grady Health SystemRecruiting
- Emory University Hospital MidtownRecruiting
- Emory University Hospital/Winship Cancer InstituteRecruiting
- Emory Saint Joseph's HospitalRecruiting
- Hawaii Cancer Care - WestridgeRecruiting
- Pali Momi Medical Center
- Hawaii Cancer Care Inc - Waterfront PlazaRecruiting
- Queen's Cancer Cenrer - POB IRecruiting
- Queen's Medical CenterRecruiting
- Straub Clinic and Hospital
- University of Hawaii Cancer CenterRecruiting
- Hawaii Cancer Care Inc-LilihaRecruiting
- Queen's Cancer Center - KuakiniRecruiting
- Kapiolani Medical Center for Women and ChildrenRecruiting
- Wilcox Memorial Hospital and Kauai Medical ClinicRecruiting
- Saint Alphonsus Cancer Care Center-BoiseRecruiting
- Saint Alphonsus Cancer Care Center-CaldwellRecruiting
- Saint Alphonsus Cancer Care Center-NampaRecruiting
- Northwestern UniversityRecruiting
- Carle on VermilionRecruiting
- Cancer Care Specialists of Illinois - DecaturRecruiting
- Decatur Memorial HospitalRecruiting
- Northwestern Medicine Cancer Center KishwaukeeRecruiting
- Carle Physician Group-EffinghamRecruiting
- Northwestern Medicine Cancer Center DelnorRecruiting
- Carle Physician Group-Mattoon/CharlestonRecruiting
- Carle Cancer CenterRecruiting
- The Carle Foundation HospitalRecruiting
- Northwestern Medicine Cancer Center WarrenvilleRecruiting
- Jewish Hospital
- UPMC Western MarylandRecruiting
- Dana-Farber Cancer InstituteRecruiting
- Wayne State University/Karmanos Cancer InstituteRecruiting
- Saint John Macomb-Oakland Hospital
- Siteman Cancer Center at West County HospitalRecruiting
- Washington University School of MedicineRecruiting
- Siteman Cancer Center-South CountyRecruiting
- Siteman Cancer Center at Christian HospitalRecruiting
- Siteman Cancer Center at Saint Peters HospitalRecruiting
- CoxHealth South HospitalRecruiting
- Cooper Hospital University Medical CenterRecruiting
- Overlook HospitalRecruiting
- MD Anderson Cancer Center at Cooper-VoorheesRecruiting
- University of New Mexico Cancer CenterRecruiting
- Montefiore Medical Center-Einstein Campus
- Mount Sinai HospitalRecruiting
- NYP/Weill Cornell Medical CenterRecruiting
- Indu and Raj Soin Medical CenterRecruiting
- Ohio State University Comprehensive Cancer CenterRecruiting
- Kettering Medical CenterRecruiting
- University of Oklahoma Health Sciences CenterRecruiting
- Oregon Health and Science University
- Bryn Mawr HospitalRecruiting
- Geisinger Medical CenterRecruiting
- Fox Chase Cancer Center - East Norriton Hospital Outpatient Center
- Riddle Memorial HospitalRecruiting
- Paoli Memorial HospitalRecruiting
- Fox Chase Cancer CenterRecruiting
- Geisinger Wyoming Valley/Henry Cancer CenterRecruiting
- Lankenau Medical CenterRecruiting
- Rhode Island HospitalRecruiting
- Medical University of South CarolinaRecruiting
- Gibbs Cancer Center-GaffneyRecruiting
- Gibbs Cancer Center-PelhamRecruiting
- Spartanburg Medical CenterRecruiting
- MGC Hematology Oncology-UnionRecruiting
- Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
- University of Texas Health Science Center at San AntonioRecruiting
- Huntsman Cancer Institute/University of UtahRecruiting
- FHCC South Lake UnionRecruiting
- Fred Hutchinson Cancer Research CenterRecruiting
- University of Washington Medical Center - MontlakeRecruiting
- Marshfield Medical Center-EC Cancer CenterRecruiting
- University of Wisconsin Carbone Cancer CenterRecruiting
- Marshfield Medical Center-MarshfieldRecruiting
- Marshfield Clinic-Minocqua CenterRecruiting
- Marshfield Medical Center-Rice LakeRecruiting
- Marshfield Medical Center-River Region at Stevens PointRecruiting
- UW Cancer Center at ProHealth Care
- Marshfield Medical Center - WestonRecruiting
Arms of the Study
Arm 1
Experimental
Diagnostic (FDG-PET/CT)
Patients receive FDG 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.