New scan could reveal which breast cancer patients will respond to hormone therapy
NCT ID NCT02398773
First seen Jun 27, 2026 · Last updated Jun 30, 2026 · Updated 2 times
Summary
This phase 2 trial tests whether a PET scan using a radioactive form of estrogen (FES) can predict how well endocrine therapy works in 99 women with newly diagnosed metastatic breast cancer. The scan lights up cancer cells that have estrogen receptors, helping doctors see if the tumor is likely to respond to hormone-blocking treatment. The goal is to avoid giving ineffective therapies and their side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- F-18 16 alpha-fluoroestradiol (FES), a radioactive form of estrogen
- What this could lead to
- If successful, this could help doctors quickly identify which patients will benefit from endocrine therapy, avoiding ineffective treatments and their side effects.
- What could go wrong
- This is a phase 2 trial with only 99 participants, so results may not apply to everyone. The scan's accuracy in predicting response is still being tested and may not be definitive.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 99 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2016
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Capable and willing to provide informed consent * Women must not be pregnant or breast-feeding. All females of childbearing potential must have a blood test or urine study within 7 days prior to FES PET/CT scan and \[18F\]-fluorodeoxyglucose (FDG)-PET/CT scan to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: * Has not undergone a hysterectomy or bilateral oophorectomy or * Has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months) * Women of childbearing potential and sexually active males must use an accepted and effective method of contraception or to abstain from sexual intercourse for the duration of their participation in the study * Patient is a postmenopausal woman, man, or premenopausal woman for whom standard endocrine therapy alone (tamoxifen, aromatase inhibitor \[AI\], with or without ovarian suppression or fulvestrant) is planned after FES-PET/CT is completed * Medically stable as judged by patient's physician * Life expectancy must be estimated by patient's physician at \> 6 months * Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-3 (restricted to ECOG performance status \[PS\] 0-2 if age \> 70 years) * Patient must NOT have a history of allergic reaction attributable to compounds of similar chemical or biologic composition to 18F-FES * Patient must NOT be in liver failure as judged by the patient's physician * Histologically confirmed metastatic breast cancer * Primary tumor and/or metastatic site must be ER+ and may be progesterone-receptor positive (PgR+) or progesterone-receptor negative (PgR-) by IHC; patients with a history of an estrogen-receptor negative (ER-) primary tumor and a documented ER+ metastatic site are eligible * The pathology report and either (1) tissue (blocks or an unstained slides) or (2) a photomicrograph of the ER IHC slides from at least one site of metastatic disease and/or from primary breast cancer must be available for central review and analysis * NOTE: if photomicrographs are submitted, the submission of hematoxylin and eosin (H\&E), PR and Ki67 IHC's, if performed, are also to be submitted * Patient must NOT have human epidermal growth factor-2 positive (HER2+) metastatic disease * Patient must NOT be planning to receive molecular targeted therapy (such as everolimus or palbociclib) nor HER2 directed therapy in addition to endocrine therapy * Patient must NOT have received prior endocrine therapy for metastatic disease (i.e., must be first-line endocrine therapy for metastatic disease) * Patient is not now, and never has received adjuvant endocrine therapy OR patient is currently receiving or has received adjuvant endocrine therapy in the past, AND adjuvant endocrine therapy was initiated \> 2 years prior to diagnosis of metastatic disease * Note: patients who developed metastatic disease while still receiving adjuvant endocrine therapy must have a planned change in the type of endocrine agent used for subsequent metastatic disease treatment; patient is not receiving blocking adjuvant therapy (such as toremifene or tamoxifen) OR patient is receiving blocking adjuvant therapy, but will stop this therapy a minimum of 60 days prior to FES-PET/CT while still complying with the study timeline * Patient must NOT have a history of \> 1 line of administered chemotherapy for metastatic disease and must be off chemotherapy for a minimum of 2 weeks; prior chemotherapy in the adjuvant setting is allowed * Disease may be measurable (by Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1 criteria) or non-measurable but must be present in at least one non-liver site, where presence is defined as 1.5 cm or greater and visualized on PET/CT with \[18F\]-fluorodeoxyglucose (FDG); patients with effusion only disease or disease only in the liver are not eligible for the study * Patient must be able to lie still for a 20-30 minute PET/CT scan * Patient must NOT weigh more than the maximum weight limit for the table for the PET/CT scanner at the institution where the study is being performed * 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 scanner qualification procedures and received ECOG-ACRIN (or current ACRIN) approval
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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City of Hope Comprehensive Cancer Center
Duarte, California, 91010, United States
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Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
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Fox Chase Cancer Center - East Norriton Hospital Outpatient Center
East Norriton, Pennsylvania, 19401, United States
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Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112, United States
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Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202, United States
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Los Angeles General Medical Center
Los Angeles, California, 90033, United States
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Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
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Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
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Mount Sinai Hospital
New York, New York, 10029, United States
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Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
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ProHealth D N Greenwald Center
Mukwonago, Wisconsin, 53149, United States
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ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, 53066, United States
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ProHealth Waukesha Memorial Hospital
Waukesha, Wisconsin, 53188, United States
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Sidney and Lois Eskenazi Hospital
Indianapolis, Indiana, 46202, United States
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Springmill Medical Center
Indianapolis, Indiana, 46290, United States
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UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599, United States
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USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
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UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390, United States
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UW Cancer Center at ProHealth Care
Waukesha, Wisconsin, 53188, United States
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University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233, United States
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University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, 19104, United States
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University of Washington Medical Center - Montlake
Seattle, Washington, 98195, United States
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University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, 53792, United States
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Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232, United States
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Washington University School of Medicine
St Louis, Missouri, 63110, United States
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Other studies related to the condition(s) this trial covers.
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