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New scan could improve how we monitor bone metastases in breast cancer

NCT ID NCT04316117

Knowledge-focused Sponsor: ECOG-ACRIN Cancer Research Group Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 15, 2026 · Updated 4 times

Summary

This phase 2 trial is testing whether a special type of PET/CT scan (FDG-PET/CT) can better measure how breast cancer that has spread to the bones responds to treatment. The study involves 138 participants with hormone receptor-positive metastatic breast cancer that is mostly in the bones. Researchers will compare the scan results to standard imaging to see if it can predict how long patients live without their cancer getting worse.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Fludeoxyglucose F-18 (FDG) and PET/CT scan
What this could lead to
If successful, this could lead to a more accurate way to measure how well breast cancer treatment is working when the cancer has spread to the bones.
What could go wrong
This is a phase 2 trial with 138 participants, so results are still early. The test may not prove better than standard imaging, and it involves radiation exposure from the PET/CT scan.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

138 people

The number who actually took part.

Started

Sep 2020

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma breast neoplasm hormone receptor-positive breast cancer metastatic carcinoma in the bone metastatic neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anatomic stage IV breast cancer ajcc V8 Hormone receptor-positive breast carcinoma Metastatic breast carcinoma Prognostic stage IV breast cancer ajcc V8

Contacts and locations

Locations

  • Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407, United States

  • Bayhealth Hospital Kent Campus

    Dover, Delaware, 19901, United States

  • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

    Houston, Texas, 77030, United States

  • Bryn Mawr Hospital

    Bryn Mawr, Pennsylvania, 19010, United States

  • Cancer Care Specialists of Illinois - Decatur

    Decatur, Illinois, 62526, United States

  • Cancer Center at Saint Joseph's

    Phoenix, Arizona, 85004, United States

  • Cancer Center-Metro Medical Center Bayamon

    Bayamón, 00959-5060, Puerto Rico

  • Carle Cancer Center

    Urbana, Illinois, 61801, United States

  • Carle Physician Group-Effingham

    Effingham, Illinois, 62401, United States

  • Carle Physician Group-Mattoon/Charleston

    Mattoon, Illinois, 61938, United States

  • Carle at The Riverfront

    Danville, Illinois, 61832, United States

  • Centro Comprensivo de Cancer de UPR

    San Juan, 00927, Puerto Rico

  • Cooper Hospital University Medical Center

    Camden, New Jersey, 08103, United States

  • Cork University Hospital

    Cork, Ireland

  • CoxHealth South Hospital

    Springfield, Missouri, 65807, United States

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526, United States

  • Doctors Cancer Center

    Manati, 00674, Puerto Rico

  • Emory Saint Joseph's Hospital

    Atlanta, Georgia, 30342, United States

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308, United States

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322, United States

  • FHCC South Lake Union

    Seattle, Washington, 98109, United States

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111, United States

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109, United States

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822, United States

  • Geisinger Wyoming Valley/Henry Cancer Center

    Wilkes-Barre, Pennsylvania, 18711, United States

  • Gene Upshaw Memorial Tahoe Forest Cancer Center

    Truckee, California, 96161, United States

  • GenesisCare USA - Aventura FP

    Aventura, Florida, 33180, United States

  • Gibbs Cancer Center-Gaffney

    Gaffney, South Carolina, 29341, United States

  • Gibbs Cancer Center-Pelham

    Greer, South Carolina, 29651, United States

  • Grady Health System

    Atlanta, Georgia, 30303, United States

  • Hawaii Cancer Care - Westridge

    ‘Aiea, Hawaii, 96701, United States

  • Hawaii Cancer Care Inc - Waterfront Plaza

    Honolulu, Hawaii, 96813, United States

  • Hawaii Cancer Care Inc-Liliha

    Honolulu, Hawaii, 96817, United States

  • Huntsman Cancer Institute/University of Utah

    Salt Lake City, Utah, 84112, United States

  • Indu and Raj Soin Medical Center

    Beavercreek, Ohio, 45431, United States

  • Jewish Hospital

    Louisville, Kentucky, 40202, United States

  • Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii, 96826, United States

  • Kettering Medical Center

    Kettering, Ohio, 45429, United States

  • Lankenau Medical Center

    Wynnewood, Pennsylvania, 19096, United States

  • Los Angeles General Medical Center

    Los Angeles, California, 90033, United States

  • MD Anderson Cancer Center at Cooper-Voorhees

    Voorhees Township, New Jersey, 08043, United States

  • MGC Hematology Oncology-Union

    Union, South Carolina, 29379, United States

  • Marshfield Clinic-Minocqua Center

    Minocqua, Wisconsin, 54548, United States

  • Marshfield Medical Center - Weston

    Weston, Wisconsin, 54476, United States

  • Marshfield Medical Center-EC Cancer Center

    Eau Claire, Wisconsin, 54701, United States

  • Marshfield Medical Center-Marshfield

    Marshfield, Wisconsin, 54449, United States

  • Marshfield Medical Center-Rice Lake

    Rice Lake, Wisconsin, 54868, United States

  • Marshfield Medical Center-River Region at Stevens Point

    Stevens Point, Wisconsin, 54482, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433, United States

  • Minnesota Oncology - Burnsville

    Burnsville, Minnesota, 55337, United States

  • Minnesota Oncology Hematology PA-Maplewood

    Maplewood, Minnesota, 55109, United States

  • Minnesota Oncology Hematology PA-Woodbury

    Woodbury, Minnesota, 55125, United States

  • Montefiore Medical Center-Einstein Campus

    The Bronx, New York, 10461, United States

  • Morristown Medical Center

    Morristown, New Jersey, 07960, United States

  • Mount Sinai Hospital

    New York, New York, 10029, United States

  • NYP/Weill Cornell Medical Center

    New York, New York, 10065, United States

  • Nebraska Medicine-Bellevue

    Bellevue, Nebraska, 68123, United States

  • Nebraska Medicine-Village Pointe

    Omaha, Nebraska, 68118, United States

  • Northwestern Medicine Cancer Center Delnor

    Geneva, Illinois, 60134, United States

  • Northwestern Medicine Cancer Center Kishwaukee

    DeKalb, Illinois, 60115, United States

  • Northwestern Medicine Cancer Center Warrenville

    Warrenville, Illinois, 60555, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210, United States

  • Oregon Health and Science University

    Portland, Oregon, 97239, United States

  • Overlook Hospital

    Summit, New Jersey, 07902, United States

  • Pali Momi Medical Center

    ‘Aiea, Hawaii, 96701, United States

  • Paoli Memorial Hospital

    Paoli, Pennsylvania, 19301, United States

  • Queen's Cancer Cenrer - POB I

    Honolulu, Hawaii, 96813, United States

  • Queen's Cancer Center - Kuakini

    Honolulu, Hawaii, 96817, United States

  • Queen's Medical Center

    Honolulu, Hawaii, 96813, United States

  • Rhode Island Hospital

    Providence, Rhode Island, 02903, United States

  • Riddle Memorial Hospital

    Media, Pennsylvania, 19063, United States

  • Saint Alphonsus Cancer Care Center-Boise

    Boise, Idaho, 83706, United States

  • Saint Alphonsus Cancer Care Center-Caldwell

    Caldwell, Idaho, 83605, United States

  • Saint Alphonsus Cancer Care Center-Nampa

    Nampa, Idaho, 83687, United States

  • Saint John Macomb-Oakland Hospital

    Warren, Michigan, 48093, United States

  • San Juan City Hospital

    San Juan, 00936, Puerto Rico

  • San Juan Community Oncology Group

    San Juan, 00917, Puerto Rico

  • Siteman Cancer Center at Christian Hospital

    St Louis, Missouri, 63136, United States

  • Siteman Cancer Center at Saint Peters Hospital

    City of Saint Peters, Missouri, 63376, United States

  • Siteman Cancer Center at West County Hospital

    Creve Coeur, Missouri, 63141, United States

  • Siteman Cancer Center-South County

    St Louis, Missouri, 63129, United States

  • Spartanburg Medical Center

    Spartanburg, South Carolina, 29303, United States

  • Straub Clinic and Hospital

    Honolulu, Hawaii, 96813, United States

  • The Carle Foundation Hospital

    Urbana, Illinois, 61801, United States

  • UCSF Medical Center-Mission Bay

    San Francisco, California, 94158, United States

  • UPMC Western Maryland

    Cumberland, Maryland, 21502, United States

  • USC / Norris Comprehensive Cancer Center

    Los Angeles, California, 90033, United States

  • UW Cancer Center at ProHealth Care

    Waukesha, Wisconsin, 53188, United States

  • United Hospital

    Saint Paul, Minnesota, 55102, United States

  • University of Alabama at Birmingham Cancer Center

    Birmingham, Alabama, 35233, United States

  • University of California Davis Comprehensive Cancer Center

    Sacramento, California, 95817, United States

  • University of Hawaii Cancer Center

    Honolulu, Hawaii, 96813, United States

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198, United States

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87102, United States

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104, United States

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229, United States

  • University of Washington Medical Center - Montlake

    Seattle, Washington, 98195, United States

  • University of Wisconsin Carbone Cancer Center

    Madison, Wisconsin, 53792, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

  • Wayne State University/Karmanos Cancer Institute

    Detroit, Michigan, 48201, United States

  • Wilcox Memorial Hospital and Kauai Medical Clinic

    Lihue, Hawaii, 96766, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.