NCT04316117Active, not recruitingPhase 2
Using FDG-PET/CT to Assess Response of Bone-Dominant Metastatic Breast Cancer, FEATURE Study
FDG PET to Assess Therapeutic Response in Patients With Bone-Dominant Metastatic Breast Cancer, FEATURE
Source: ClinicalTrials.gov · Last updated 19 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 138 (actual)
- First submitted
- 18 Mar 2020
- Start date
- 15 Sept 2020
- Primary completion date
- 31 Aug 2027
- Lead sponsor
- ECOG-ACRIN Cancer Research Group
- Diseases
- Metastatic breast cancer
- NCT number
- NCT04316117
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 138
- From 15 Sept 2020 to the primary completion date, 31 Aug 2027
- 104 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- 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
Other illness
- 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
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (104)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cork University Hospital Coordinator of this site? Confirm its status | Cork | Ireland | Unknown status |
| Cancer Center-Metro Medical Center Bayamon Coordinator of this site? Confirm its status | Bayamón | Puerto Rico | Unknown status |
| Doctors Cancer Center Coordinator of this site? Confirm its status | Manati | Puerto Rico | Unknown status |
| Centro Comprensivo de Cancer de UPR Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Unknown status |
| San Juan City Hospital Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Unknown status |
| San Juan Community Oncology Group Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Unknown status |
| Hawaii Cancer Care - Westridge Coordinator of this site? Confirm its status | ‘Aiea | United States | Unknown status |
| Pali Momi Medical Center Coordinator of this site? Confirm its status | ‘Aiea | United States | Unknown status |
| University of New Mexico Cancer Center Coordinator of this site? Confirm its status | Albuquerque | United States | Unknown status |
| Emory Saint Joseph's Hospital Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Emory University Hospital Midtown Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Grady Health System Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Emory University Hospital/Winship Cancer Institute Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| GenesisCare USA - Aventura FP Coordinator of this site? Confirm its status | Aventura | United States | Unknown status |
| Indu and Raj Soin Medical Center Coordinator of this site? Confirm its status | Beavercreek | United States | Unknown status |
| Nebraska Medicine-Bellevue Coordinator of this site? Confirm its status | Bellevue | United States | Unknown status |
| University of Alabama at Birmingham Cancer Center Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| Saint Alphonsus Cancer Care Center-Boise Coordinator of this site? Confirm its status | Boise | United States | Unknown status |
| Dana-Farber Cancer Institute Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Bryn Mawr Hospital Coordinator of this site? Confirm its status | Bryn Mawr | United States | Unknown status |
| Minnesota Oncology - Burnsville Coordinator of this site? Confirm its status | Burnsville | United States | Unknown status |
| Saint Alphonsus Cancer Care Center-Caldwell Coordinator of this site? Confirm its status | Caldwell | United States | Unknown status |
| Cooper Hospital University Medical Center Coordinator of this site? Confirm its status | Camden | United States | Unknown status |
| Medical University of South Carolina Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| Northwestern University Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Siteman Cancer Center at Saint Peters Hospital Coordinator of this site? Confirm its status | City of Saint Peters | United States | Unknown status |
| Ohio State University Comprehensive Cancer Center Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| Mercy Hospital Coordinator of this site? Confirm its status | Coon Rapids | United States | Unknown status |
| Siteman Cancer Center at West County Hospital Coordinator of this site? Confirm its status | Creve Coeur | United States | Unknown status |
| UPMC Western Maryland Coordinator of this site? Confirm its status | Cumberland | United States | Unknown status |
| Carle at The Riverfront Coordinator of this site? Confirm its status | Danville | United States | Unknown status |
| Geisinger Medical Center Coordinator of this site? Confirm its status | Danville | United States | Unknown status |
| Cancer Care Specialists of Illinois - Decatur Coordinator of this site? Confirm its status | Decatur | United States | Unknown status |
| Decatur Memorial Hospital Coordinator of this site? Confirm its status | Decatur | United States | Unknown status |
| Northwestern Medicine Cancer Center Kishwaukee Coordinator of this site? Confirm its status | DeKalb | United States | Unknown status |
| Wayne State University/Karmanos Cancer Institute Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| Bayhealth Hospital Kent Campus Coordinator of this site? Confirm its status | Dover | United States | Unknown status |
| Marshfield Medical Center-EC Cancer Center Coordinator of this site? Confirm its status | Eau Claire | United States | Unknown status |
| Carle Physician Group-Effingham Coordinator of this site? Confirm its status | Effingham | United States | Unknown status |
| Gibbs Cancer Center-Gaffney Coordinator of this site? Confirm its status | Gaffney | United States | Unknown status |
| Northwestern Medicine Cancer Center Delnor Coordinator of this site? Confirm its status | Geneva | United States | Unknown status |
| Gibbs Cancer Center-Pelham Coordinator of this site? Confirm its status | Greer | United States | Unknown status |
| Hawaii Cancer Care Inc - Waterfront Plaza Coordinator of this site? Confirm its status | Honolulu | United States | Unknown status |
| Queen's Medical Center Coordinator of this site? Confirm its status | Honolulu | United States | Unknown status |
| Queen's Cancer Cenrer - POB I Coordinator of this site? Confirm its status | Honolulu | United States | Unknown status |
| Queen's Cancer Center - Kuakini Coordinator of this site? Confirm its status | Honolulu | United States | Unknown status |
| Straub Clinic and Hospital Coordinator of this site? Confirm its status | Honolulu | United States | Unknown status |
| University of Hawaii Cancer Center Coordinator of this site? Confirm its status | Honolulu | United States | Unknown status |
| Hawaii Cancer Care Inc-Liliha Coordinator of this site? Confirm its status | Honolulu | United States | Unknown status |
| Kapiolani Medical Center for Women and Children Coordinator of this site? Confirm its status | Honolulu | United States | Unknown status |
| Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Kettering Medical Center Coordinator of this site? Confirm its status | Kettering | United States | Unknown status |
| Wilcox Memorial Hospital and Kauai Medical Clinic Coordinator of this site? Confirm its status | Lihue | United States | Unknown status |
| USC / Norris Comprehensive Cancer Center Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Los Angeles General Medical Center Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Jewish Hospital Coordinator of this site? Confirm its status | Louisville | United States | Unknown status |
| University of Wisconsin Carbone Cancer Center Coordinator of this site? Confirm its status | Madison | United States | Unknown status |
| Minnesota Oncology Hematology PA-Maplewood Coordinator of this site? Confirm its status | Maplewood | United States | Unknown status |
| Marshfield Medical Center-Marshfield Coordinator of this site? Confirm its status | Marshfield | United States | Unknown status |
| Carle Physician Group-Mattoon/Charleston Coordinator of this site? Confirm its status | Mattoon | United States | Unknown status |
| Riddle Memorial Hospital Coordinator of this site? Confirm its status | Media | United States | Unknown status |
| Abbott-Northwestern Hospital Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| Marshfield Clinic-Minocqua Center Coordinator of this site? Confirm its status | Minocqua | United States | Unknown status |
| Morristown Medical Center Coordinator of this site? Confirm its status | Morristown | United States | Unknown status |
| Saint Alphonsus Cancer Care Center-Nampa Coordinator of this site? Confirm its status | Nampa | United States | Unknown status |
| Mount Sinai Hospital Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| NYP/Weill Cornell Medical Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| University of Oklahoma Health Sciences Center Coordinator of this site? Confirm its status | Oklahoma City | United States | Unknown status |
| Nebraska Medicine-Village Pointe Coordinator of this site? Confirm its status | Omaha | United States | Unknown status |
| University of Nebraska Medical Center Coordinator of this site? Confirm its status | Omaha | United States | Unknown status |
| Paoli Memorial Hospital Coordinator of this site? Confirm its status | Paoli | United States | Unknown status |
| Fox Chase Cancer Center Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Cancer Center at Saint Joseph's Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Oregon Health and Science University Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Rhode Island Hospital Coordinator of this site? Confirm its status | Providence | United States | Unknown status |
| Marshfield Medical Center-Rice Lake Coordinator of this site? Confirm its status | Rice Lake | United States | Unknown status |
| University of California Davis Comprehensive Cancer Center Coordinator of this site? Confirm its status | Sacramento | United States | Unknown status |
| United Hospital Coordinator of this site? Confirm its status | Saint Paul | United States | Unknown status |
| Huntsman Cancer Institute/University of Utah Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| University of Texas Health Science Center at San Antonio Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| UCSF Medical Center-Mission Bay Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| Fred Hutchinson Cancer Research Center Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| FHCC South Lake Union Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| University of Washington Medical Center - Montlake Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| Spartanburg Medical Center Coordinator of this site? Confirm its status | Spartanburg | United States | Unknown status |
| CoxHealth South Hospital Coordinator of this site? Confirm its status | Springfield | United States | Unknown status |
| Marshfield Medical Center-River Region at Stevens Point Coordinator of this site? Confirm its status | Stevens Point | United States | Unknown status |
| Siteman Cancer Center-South County Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Siteman Cancer Center at Christian Hospital Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Washington University School of Medicine Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Overlook Hospital Coordinator of this site? Confirm its status | Summit | United States | Unknown status |
| Montefiore Medical Center-Einstein Campus Coordinator of this site? Confirm its status | The Bronx | United States | Unknown status |
| Gene Upshaw Memorial Tahoe Forest Cancer Center Coordinator of this site? Confirm its status | Truckee | United States | Unknown status |
| MGC Hematology Oncology-Union Coordinator of this site? Confirm its status | Union | United States | Unknown status |
| The Carle Foundation Hospital Coordinator of this site? Confirm its status | Urbana | United States | Unknown status |
| Carle Cancer Center Coordinator of this site? Confirm its status | Urbana | United States | Unknown status |
| MD Anderson Cancer Center at Cooper-Voorhees Coordinator of this site? Confirm its status | Voorhees Township | United States | Unknown status |
| Saint John Macomb-Oakland Hospital Coordinator of this site? Confirm its status | Warren | United States | Unknown status |
| Northwestern Medicine Cancer Center Warrenville Coordinator of this site? Confirm its status | Warrenville | United States | Unknown status |
| UW Cancer Center at ProHealth Care Coordinator of this site? Confirm its status | Waukesha | United States | Unknown status |
| Marshfield Medical Center - Weston Coordinator of this site? Confirm its status | Weston | United States | Unknown status |
| Geisinger Wyoming Valley/Henry Cancer Center Coordinator of this site? Confirm its status | Wilkes-Barre | United States | Unknown status |
| Minnesota Oncology Hematology PA-Woodbury Coordinator of this site? Confirm its status | Woodbury | United States | Unknown status |
| Lankenau Medical Center Coordinator of this site? Confirm its status | Wynnewood | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.