IRB #

STUDY00021441

Title

EA1183: FDG PET to Assess Therapeutic Response in Patients with Bone-Dominant Metastatic Breast Cancer, FEATURE

Principal Investigator

Zahi Mitri

Study Purpose

The purpose of this study is to determine if FDG-PET/CT can provide a better assessment of how metastatic breast cancer is responding to treatment than the standard of care imaging.

Medical Condition(s)

metastatic breast cancer

Eligibility Criteria

Histologically confirmed metastatic breast cancer by local assessment that is hormone receptor positive by ASCO/CAP guidelines and with known HER2 status.
Patients must have radiologically confirmed bone-dominant (BD) or bone-only (BO) disease.
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 dyas of registration are eligible.
Patients must be 18 years of age or older
Performance status of 2 or less
No contraindication to FEG-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 SERMs, aromatase inhibitors, and/or fulvestrant that may be combined with FDA-approved biologic agents (palbociclib, ribociclib, abemaciclib, everolimus, alpelisib). Chemotherapy per 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 12weeks. 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 is permitted
Patient’s life expectancy must be estimated at ≥ 24 weeks
Patients must complete the baseline (T0) FDG-PET within 28 days prior to registration or within 28 days after registration.

Age Range

18 - 99

Healthy Volunteers Needed

No

Duration of Participation

until progression

Minors Included

No

Contact

Knight Cancer Institute Clinical Trials
trials@ohsu.edu
503 494-1080

Sponsor

ECOG-ACRIN

Recruitment End

05/31/2022

Compensation Provided

No


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