Trial Outcomes & Findings for F-18 FES PET/CT in Measuring Hormone Expression in Patients With Primary, Recurrent, or Metastatic Breast Cancer Undergoing Endocrine-Targeted Therapy (NCT NCT02149173)

Last Updated: 2021-06-30

Results Overview

Uptake was quantified using lean body mass adjusted SUV (SULmean). The geometric mean was calculated for up to 3 lesions per patient. Systematic change in FES SULgmean between baseline and a second FES scan at approximately 2 or 8 weeks and a third FES scan was at approximately 8 weeks measured using a sign test where the median change is zero.

Recruitment status

TERMINATED

Study phase

Target enrollment

29 participants

Primary outcome timeframe

from time of first F-18 FES-PET/CT scan to time of second or third F-18 FES-PET/CT scan (approximately 2-8 weeks)

Results posted on

2021-06-30

Participant Flow

Participant milestones

Participant milestones
Measure	Diagnostic (F-18 FES PET/CT) Patients undergo F-18 FES PET/CT scan at baseline. Patients also undergo F-18 FES PET/CT and FDG PET/CT between 1-12 weeks after starting therapy, and then 1-12 weeks after the second FES PET/CT scan. Repeat FDG PET may be omitted in patients on selective estrogen receptor degrader.
Overall Study STARTED	29
Overall Study COMPLETED	29
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

F-18 FES PET/CT in Measuring Hormone Expression in Patients With Primary, Recurrent, or Metastatic Breast Cancer Undergoing Endocrine-Targeted Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Diagnostic (F-18 FES PET/CT) n=29 Participants Patients undergo F-18 FES PET/CT scan at baseline. Patients also undergo F-18 FES PET/CT and FDG PET/CT between 1-12 weeks after starting therapy, and then 1-12 weeks after the second FES PET/CT scan. Repeat FDG PET may be omitted in patients on selective estrogen receptor degrader.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=5 Participants
Age, Categorical >=65 years	12 Participants n=5 Participants
Age, Continuous	62 years n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	29 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	25 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	29 participants n=5 Participants

PRIMARY outcome

Timeframe: from time of first F-18 FES-PET/CT scan to time of second or third F-18 FES-PET/CT scan (approximately 2-8 weeks)

Population: 15/23 patients underwent a second FES PET/CT scan approximately 2 wks after starting potential ER modulating (vorinostat) therapy. 14/23 underwent a second or third FES PET/CT scan approximately 8 wks after starting vorinostat therapy. 6 patients underwent a second FES PET/CT scan between 2-8 wks after starting potential ER blocking therapy.

Outcome measures

Outcome measures
Measure	FES-imaging After 2 Wks of ER Modulating (Vorinostat) Therapy n=15 Participants Patients undergo F-18 FES PET/CT and FDG PET/CT scans at baseline. Patients also undergo F-18 FES PET/CT between approximately 2 weeks after starting therapy	FES-imaging After 8 Wks of ER Modulating (Vorinostat) Therapy n=14 Participants Patients undergo F-18 FES PET/CT and FDG PET/CT scans at baseline. Patients also undergo F-18 FES PET/CT between approximately 8 weeks after starting therapy	FES-imaging After 2-8 Weeks of ER Blocking Therapy n=6 Participants Patients undergo F-18 FES PET/CT and FDG PET/CT scans at baseline. Patients also undergo F-18 FES PET/CT between approximately 2-8 weeks after starting estrogen receptor blocking therapy.
Change in F-18 16 Alpha-fluoroestradiol (FES) Standardized Uptake Value (SUV), Assessed by a One-sample Test of the Percent Change in FES SUV	8.7 percentage of change in SULgmean Interval -22.2 to 54.7	1.9 percentage of change in SULgmean Interval -61.5 to 113.9	-60.3 percentage of change in SULgmean Interval -91.0 to -14.0

PRIMARY outcome

Timeframe: from time of first F-18 FES-PET/CT scan to time of second or third F-18 FES-PET/CT scan (approximately 2-8 weeks)

Population: quantitative and qualitative measure of FES positive lesions

Quantitative and qualitative measures of FES uptake for each disease site, a set of 1.5 cm diameter regions on three adjacent planes with the highest lesion FES uptake will be drawn to determine maximal FES uptake. Up to 10 sites seen on the static torso survey will be quantified. Lesions will qualitatively determined to be visible or not visible.

Outcome measures

Outcome measures
Measure	FES-imaging After 2 Wks of ER Modulating (Vorinostat) Therapy n=314 number of ER+ lesions Patients undergo F-18 FES PET/CT and FDG PET/CT scans at baseline. Patients also undergo F-18 FES PET/CT between approximately 2 weeks after starting therapy	FES-imaging After 8 Wks of ER Modulating (Vorinostat) Therapy n=314 number of ER+ lesions Patients undergo F-18 FES PET/CT and FDG PET/CT scans at baseline. Patients also undergo F-18 FES PET/CT between approximately 8 weeks after starting therapy	FES-imaging After 2-8 Weeks of ER Blocking Therapy Patients undergo F-18 FES PET/CT and FDG PET/CT scans at baseline. Patients also undergo F-18 FES PET/CT between approximately 2-8 weeks after starting estrogen receptor blocking therapy.
F-18 16 Alpha-fluoroestradiol (FES) Uptake	281 number of ER+ lesions	243 number of ER+ lesions	—

PRIMARY outcome

Timeframe: from time of first F-18 FES-PET/CT scan to time of second or third F-18 FES-PET/CT scan (approximately 2-8 weeks)

Population: The patient arms different from Primary Outcome 1 because they are separated according to the type of therapy each group had (ER modulating or ER blocking), not by the number of FES scans that they had. Results are based on the change between 2 scans.

The number of patients showing a 20% increase in FES SULgmean compared to baseline at either 2 or 8 weeks using a 90% Wilson score binomial confidence interval.

Outcome measures

Outcome measures
Measure	FES-imaging After 2 Wks of ER Modulating (Vorinostat) Therapy n=23 Participants Patients undergo F-18 FES PET/CT and FDG PET/CT scans at baseline. Patients also undergo F-18 FES PET/CT between approximately 2 weeks after starting therapy	FES-imaging After 8 Wks of ER Modulating (Vorinostat) Therapy n=6 Participants Patients undergo F-18 FES PET/CT and FDG PET/CT scans at baseline. Patients also undergo F-18 FES PET/CT between approximately 8 weeks after starting therapy	FES-imaging After 2-8 Weeks of ER Blocking Therapy Patients undergo F-18 FES PET/CT and FDG PET/CT scans at baseline. Patients also undergo F-18 FES PET/CT between approximately 2-8 weeks after starting estrogen receptor blocking therapy.
Proportion of Patients Experienced a Threshold in Percentage Change, or Surpassed a Targeted Follow-up F-18 16 Alpha-fluoroestradiol (FES) Standardized Uptake Value (SUV)	0 Proportion of participants Interval 0.0 to 0.21	0 Proportion of participants Interval 0.0 to 0.31	—

SECONDARY outcome

Timeframe: from start of therapy up to 20 years

Months from the start of endocrine therapy to the time the patient is first recorded as having disease progression,

Outcome measures

Outcome measures
Measure	FES-imaging After 2 Wks of ER Modulating (Vorinostat) Therapy n=23 Participants Patients undergo F-18 FES PET/CT and FDG PET/CT scans at baseline. Patients also undergo F-18 FES PET/CT between approximately 2 weeks after starting therapy	FES-imaging After 8 Wks of ER Modulating (Vorinostat) Therapy n=6 Participants Patients undergo F-18 FES PET/CT and FDG PET/CT scans at baseline. Patients also undergo F-18 FES PET/CT between approximately 8 weeks after starting therapy	FES-imaging After 2-8 Weeks of ER Blocking Therapy Patients undergo F-18 FES PET/CT and FDG PET/CT scans at baseline. Patients also undergo F-18 FES PET/CT between approximately 2-8 weeks after starting estrogen receptor blocking therapy.
Time to Disease Progression	2 months Interval 0.1 to 21.2	5.6 months Interval 1.4 to 8.4	—

Adverse Events

Diagnostic (F-18 FES PET/CT)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 24 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Hannah M Linden

University of Washington

Phone: 206-606-2053

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place