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Using FDG-PET / CT to Assess Response of Bone-Dominant Metastatic Breast Cancer, FEATURE Study

Trial Status: Active

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.

Inclusion Criteria

  • Patient must have an Eastern Cooperative Oncology Group (ECOG) performance (performance status [PS]) =< 2
  • Patient 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. * NOTE: Confirmation can be documented via a report from a metastatic biopsy; a separate biopsy does not need to be completed. If there is no report from a metastatic biopsy, the pathology report from primary breast cancer diagnosis documenting breast cancer along with estrogen receptor (ER), progesterone receptor (PR) and HER2 status can be utilized
  • Patient must have radiologically confirmed bone-dominant (BD) or bone-only (BO) disease confirmed by scans obtained within 60 days prior to registration * 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
  • Patient must have no contraindication to FDG-PET imaging which includes glucose values > 200 mg/dL and severe claustrophobia
  • Patient must have one of the following systemic therapies: * Plan to receive either 1st, 2nd or 3rd 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 (examples include CDK 4/6 inhibitors mTOR inhibitors and parp inhibitors for BRCA germ mutation) * Plan to receive 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 * NOTE: 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 must have life expectancy estimated at >= 24 weeks
  • Patient must be 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
  • Patient must complete the baseline (T0) FDG-PET within 28 days after registration. A FDG-PET/CT completed prior to registration may be used if all imaging parameters have been met and patient is able to start treatment within 21 days after completion of FDG/PET CT * 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 all parameters must be met with the following exemption: ** Pregnancy testing documentation prior to FDG-PET (T0 time point) for patients of childbearing potential will not be required

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 using 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
  • Patient 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, patients who are breastfeeding are also excluded from this study. All patients of childbearing potential must have a blood test or urine study within 7 days prior to FDG-PET/CT to rule out pregnancy

Alabama

Birmingham
University of Alabama at Birmingham Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 205-934-0220

California

Los Angeles
USC / Norris Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 323-865-0451
Sacramento
University of California Davis Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 916-734-3089

Georgia

Atlanta
Emory Saint Joseph's Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 404-851-7115
Emory University Hospital / Winship Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 404-778-1868
Emory University Hospital Midtown
Status: ACTIVE
Contact: Site Public Contact
Phone: 888-946-7447
Grady Health System
Status: ACTIVE
Contact: Site Public Contact
Phone: 404-489-9164

Hawaii

Aiea
Hawaii Cancer Care - Savio
Status: ACTIVE
Contact: Site Public Contact
Phone: 808-539-2273
Pali Momi Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 808-486-6000
Honolulu
Hawaii Cancer Care Inc - Waterfront Plaza
Status: ACTIVE
Contact: Site Public Contact
Phone: 808-524-6115
Hawaii Cancer Care Inc-Liliha
Status: ACTIVE
Contact: Site Public Contact
Phone: 808-536-4888
Kapiolani Medical Center for Women and Children
Status: ACTIVE
Contact: Site Public Contact
Phone: 808-983-6090
Queen's Cancer Cenrer - POB I
Status: ACTIVE
Contact: Site Public Contact
Phone: 808-532-0315
Queen's Cancer Center - Kuakini
Status: ACTIVE
Contact: Site Public Contact
Phone: 808-531-8521
Queen's Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 808-545-8548
Straub Clinic and Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 808-522-4333
University of Hawaii Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 808-586-2979
Lihue
Wilcox Memorial Hospital and Kauai Medical Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 808-535-7960

Idaho

Boise
Saint Alphonsus Cancer Care Center-Boise
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Caldwell
Saint Alphonsus Cancer Care Center-Caldwell
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Nampa
Saint Alphonsus Medical Center-Nampa
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671

Illinois

Chicago
Northwestern University
Status: ACTIVE
Contact: Site Public Contact
Phone: 312-695-1301
Danville
Carle on Vermilion
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-446-5532
Decatur
Cancer Care Specialists of Illinois - Decatur
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-876-4740
Decatur Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-876-4740
Effingham
Carle Physician Group-Effingham
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-446-5532
Mattoon
Carle Physician Group-Mattoon / Charleston
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-446-5532
Urbana
Carle Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-446-5532
The Carle Foundation Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-446-5532

Kentucky

Louisville
Jewish Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518

Massachusetts

Boston
Dana-Farber Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-442-3324

Michigan

Detroit
Wayne State University / Karmanos Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 313-576-9790
Warren
Saint John Macomb-Oakland Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671

Missouri

Creve Coeur
Siteman Cancer Center at West County Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-600-3606
Saint Louis
Siteman Cancer Center at Christian Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-600-3606
Siteman Cancer Center-South County
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-600-3606
Washington University School of Medicine
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-600-3606
Saint Peters
Siteman Cancer Center at Saint Peters Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-600-3606
Springfield
CoxHealth South Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 417-269-4520

New Mexico

Albuquerque
University of New Mexico Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 505-925-0366

Ohio

Columbus
Ohio State University Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-293-5066

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 405-271-8777

Oregon

Portland
Oregon Health and Science University
Status: ACTIVE
Contact: Site Public Contact
Phone: 503-494-1080

Pennsylvania

Bryn Mawr
Bryn Mawr Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 484-476-2649
East Norriton
Fox Chase Cancer Center - East Norriton Hospital Outpatient Center
Status: ACTIVE
Contact: Site Public Contact
Media
Riddle Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 484-476-2649
Paoli
Paoli Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 484-476-2649
Philadelphia
Fox Chase Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 215-728-4790
Wynnewood
Lankenau Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 484-476-2649

South Carolina

Charleston
Medical University of South Carolina
Status: ACTIVE
Contact: Site Public Contact
Phone: 843-792-9321
Gaffney
Gibbs Cancer Center-Gaffney
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-560-6104
Greer
Gibbs Cancer Center-Pelham
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-560-6104
Spartanburg
Spartanburg Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-560-6104
Union
MGC Hematology Oncology-Union
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-560-6104

Texas

San Antonio
University of Texas Health Science Center at San Antonio
Status: ACTIVE
Contact: Site Public Contact
Phone: 210-450-3800

Washington

Seattle
Fred Hutchinson Cancer Research Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-804-8824
Seattle Cancer Care Alliance
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-804-8824
University of Washington Medical Center - Montlake
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-804-8824

Wisconsin

Waukesha
UW Cancer Center at ProHealth Care
Status: ACTIVE
Contact: Site Public Contact
Phone: 262-928-5539

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.

IV. Assess the ability of qualitative and quantitative changes in serial circulating tumor deoxyribonucleic acid (ctDNA) measures to predict PFS, tSRE, and overall survival in patients enrolled in EA1183.

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.

Trial Phase Phase II

Trial Type Diagnostic

Lead Organization
ECOG-ACRIN Cancer Research Group

Principal Investigator
Jennifer Marie Specht

  • Primary ID EA1183
  • Secondary IDs NCI-2020-00210
  • Clinicaltrials.gov ID NCT04316117