Trial Outcomes & Findings for Positron Emission Tomography in Women With Advanced HER2-Positive Breast Cancer (NCT NCT01093612)

Last Updated: 2025-11-14

Results Overview

Comparison of uptake between the HER2+ and HER2- groups, treating SUVmax measurements for individual tumors as independent observations. Statistical significance of differences in SUVmax between patient groups was assessed via a nonparametric (Wilcoxon rank-sum) test. Radiolabel uptake for tumors was measured in terms of single-voxel maximum SUV (SUVmax; SUV = tissue activity per mL x body weight \[g\]/injected activity decay-corrected to time of scan).

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

Target enrollment

18 participants

Primary outcome timeframe

24 hours after injection of 64 CU-DOTA-trastuzumab

Results posted on

2025-11-14

Participant Flow

Participant milestones

Participant milestones
Measure	HER2+ Patients HER2+ patients underwent 64Cu-DOTA-trastuzumab injection, preceded by trastuzumab infusion (45 mg). PET/CT was performed 21-25 (day 1) and 47-49 (day 2) hours after 64Cu-DOTA-trastuzumab injection. Radio-label uptake in prominent lesions was measured as SUVmax.	HER2- Patients HER2- patients underwent 64Cu-DOTA-trastuzumab injection, preceded by trastuzumab infusion (45 mg). PET/CT was performed 21-25 (day 1) and 47-49 (day 2) hours after 64Cu-DOTA-trastuzumab injection. Radio-label uptake in prominent lesions was measured as SUVmax.
Overall Study STARTED	11	7
Overall Study COMPLETED	11	7
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Positron Emission Tomography in Women With Advanced HER2-Positive Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HER2+ Patients n=11 Participants HER2+ patients underwent 64Cu-DOTA-trastuzumab injection, preceded by trastuzumab infusion (45 mg). PET/CT was performed 21-25 (day 1) and 47-49 (day 2) hours after 64Cu-DOTA-trastuzumab injection. Radio-label uptake in prominent lesions was measured as SUVmax.	HER2- Patients n=7 Participants HER2- patients underwent 64Cu-DOTA-trastuzumab injection, preceded by trastuzumab infusion (45 mg). PET/CT was performed 21-25 (day 1) and 47-49 (day 2) hours after 64Cu-DOTA-trastuzumab injection. Radio-label uptake in prominent lesions was measured as SUVmax.	Total n=18 Participants Total of all reporting groups
Age, Continuous	59 years n=10 Participants	61 years n=10 Participants	60 years n=20 Participants
Sex: Female, Male Female	11 Participants n=10 Participants	7 Participants n=10 Participants	18 Participants n=20 Participants
Sex: Female, Male Male	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Race/Ethnicity, Customized Asian	1 Participants n=10 Participants	2 Participants n=10 Participants	3 Participants n=20 Participants
Race/Ethnicity, Customized African American	2 Participants n=10 Participants	0 Participants n=10 Participants	2 Participants n=20 Participants
Race/Ethnicity, Customized Hispanic	3 Participants n=10 Participants	3 Participants n=10 Participants	6 Participants n=20 Participants
Race/Ethnicity, Customized Native American	1 Participants n=10 Participants	0 Participants n=10 Participants	1 Participants n=20 Participants
Race/Ethnicity, Customized White Non-Hispanic	4 Participants n=10 Participants	2 Participants n=10 Participants	6 Participants n=20 Participants
Region of Enrollment United States	11 participants n=10 Participants	7 participants n=10 Participants	18 participants n=20 Participants

PRIMARY outcome

Timeframe: 24 hours after injection of 64 CU-DOTA-trastuzumab

Outcome measures

Outcome measures
Measure	HER2+ Patients n=11 Participants HER2+ patients underwent 64Cu-DOTA-trastuzumab injection, preceded by trastuzumab infusion (45 mg). PET/CT was performed 21-25 (day 1) and 47-49 (day 2) hours after 64Cu-DOTA-trastuzumab injection. Radio-label uptake in prominent lesions was measured as SUVmax.	HER2- Patients n=7 Participants HER2- patients underwent 64Cu-DOTA-trastuzumab injection, preceded by trastuzumab infusion (45 mg). PET/CT was performed 21-25 (day 1) and 47-49 (day 2) hours after 64Cu-DOTA-trastuzumab injection. Radio-label uptake in prominent lesions was measured as SUVmax.
Tumor Uptake of 64Cu-DOTA-trastuzumab After 24 Hours	7.0 SUVmax (g/mL) Interval 4.8 to 10.6	3.7 SUVmax (g/mL) Interval 3.0 to 4.7

PRIMARY outcome

Timeframe: 48 hours after injection of 64 CU-DOTA-trastuzumab

Outcome measures

Outcome measures
Measure	HER2+ Patients n=11 Participants HER2+ patients underwent 64Cu-DOTA-trastuzumab injection, preceded by trastuzumab infusion (45 mg). PET/CT was performed 21-25 (day 1) and 47-49 (day 2) hours after 64Cu-DOTA-trastuzumab injection. Radio-label uptake in prominent lesions was measured as SUVmax.	HER2- Patients n=7 Participants HER2- patients underwent 64Cu-DOTA-trastuzumab injection, preceded by trastuzumab infusion (45 mg). PET/CT was performed 21-25 (day 1) and 47-49 (day 2) hours after 64Cu-DOTA-trastuzumab injection. Radio-label uptake in prominent lesions was measured as SUVmax.
Tumor Uptake of 64Cu-DOTA-trastuzumab After 48 Hours	8.7 SUVmax (g/mL) Interval 5.7 to 13.0	4.6 SUVmax (g/mL) Interval 3.8 to 5.0

Adverse Events

HER2+ Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

HER2- Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Paul Frankel, Ph.D.

City of Hope

Phone: 626-218-5265

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place