Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

138

participants targeted

Target at P75+ for phase_2

Timeline

16mo left

Started Sep 2020

Longer than P75 for phase_2

Geographic Reach

3 countries

104 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

7 years study duration

Study Progress81%

Sep 2020Aug 2027

First Submitted

Initial submission to the registry

March 18, 2020

Completed

2 days until next milestone

First Posted

Study publicly available on registry

March 20, 2020

Completed

6 months until next milestone

Study Start

First participant enrolled

September 15, 2020

Completed

7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2027

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2027

Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

7 years

First QC Date

March 18, 2020

Last Update Submit

April 29, 2026

Conditions

Anatomic Stage IV Breast Cancer AJCC v8 Metastatic Breast Carcinoma Hormone Receptor Positive Breast Carcinoma Prognostic Stage IV Breast Cancer AJCC v8

Outcome Measures

Primary Outcomes (1)

Performance of fludeoxyglucose F-18 (FDG)-positron emission tomography (PET)/computed tomography (CT) response criteria as a binary predictor of progression-free survival (PFS)
Will evaluate the performance of FDG-PET/CT response criteria (modified PET Response Criteria in Solid Tumors complete, partial and stable metabolic disease versus progressive metabolic disease) as a binary predictor of PFS in patients with bone-dominant (BD) metastatic breast cancer (MBC) treated with systemic therapy.
Up to 3 years after study registration

Secondary Outcomes (7)

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
Up to 3 years after study registration
Ability of FDG-PET/CT modified PERCIST criteria (complete, partial, and stable vs progressive metabolic disease) to predict time to skeletal related events (SRE) in patients with BD MBC
Up to 3 years after study registration
Ability of FDG-PET/CT modified PERCIST criteria (complete, partial, and stable vs progressive metabolic disease) to predict overall survival (OS) in patients with BD MBC
Up to 3 years after study registration
Ability of FDG-PET/CT metrics to predict PFS in patients with BD MBC
Up to 3 years after study registration
Ability of FDG-PET/CT metrics to predict time to SRE in patients with BD MBC
Up to 3 years after study registration
+2 more secondary outcomes

Other Outcomes (3)

Defining of criteria for selection of FDG-avid bone lesions for analysis based on thresholds for SULpeak or SUVmax
Up to 3 years after study registration
Exploration of alternative methods for measuring metabolic response with FDG-PET/CT to predict clinical endpoints in patients with BD MBC
Up to 3 years after study registration
Automated image analysis of FDG-PET/CT
Up to 3 years after study registration

Study Arms (1)

Diagnostic (FDG-PET/CT)

EXPERIMENTAL

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.

Procedure: Computed TomographyOther: Fludeoxyglucose F-18Procedure: Positron Emission Tomography

Interventions

Computed TomographyPROCEDURE

Undergo PET/CT

Also known as: CAT, CAT scan, computerized axial tomography, Computerized Tomography, CT, CT scan, tomography

Diagnostic (FDG-PET/CT)

Fludeoxyglucose F-18OTHER

Given IV

Also known as: 18FDG, FDG, Fludeoxyglucose (18F), fludeoxyglucose F 18, Fludeoxyglucose F18, Fluorine-18 2-Fluoro-2-deoxy-D-Glucose, Fluorodeoxyglucose F18

Diagnostic (FDG-PET/CT)

Positron Emission TomographyPROCEDURE

Undergo PET/CT

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, positron emission tomography scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging

Diagnostic (FDG-PET/CT)

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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
+4 more criteria

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

ECOG-ACRIN Cancer Research Grouplead
National Cancer Institute (NCI)collaborator

Study Sites (104)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, 35233, United States

Location

Cancer Center at Saint Joseph's

Phoenix, Arizona, 85004, United States

Location

Los Angeles General Medical Center

Los Angeles, California, 90033, United States

Location

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

University of California Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States

Location

UCSF Medical Center-Mission Bay

San Francisco, California, 94158, United States

Location

Gene Upshaw Memorial Tahoe Forest Cancer Center

Truckee, California, 96161, United States

Location

Bayhealth Hospital Kent Campus

Dover, Delaware, 19901, United States

Location

GenesisCare USA - Aventura FP

Aventura, Florida, 33180, United States

Location

Grady Health System

Atlanta, Georgia, 30303, United States

Location

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

Emory Saint Joseph's Hospital

Atlanta, Georgia, 30342, United States

Location

Hawaii Cancer Care Inc - Waterfront Plaza