Trial Outcomes & Findings for Ultrasound and Near Infrared Imaging for Predicting and Monitoring Neoadjuvant Treatment (NCT NCT02891681)
NCT ID: NCT02891681
Last Updated: 2021-02-16
Results Overview
In the Miller-Payne system, the pathologic response is divided into 5 grades based on comparison of tumor cellularity between pre-neoadjuvant core biopsy and definitive surgical specimen as: * grade 1: no change or some alteration to individual malignant cells but no reduction in overall cellularity (pNR) * grade 2: a minor loss of tumor cells but overall cellularity still high; up to 30% (pPR) * grade 3: between an estimated 30% and 90% reduction in tumor cells (pPR) * grade 4: a marked disappearance of tumor cells such that only small clusters or widely dispersed individual cells remain (almost pCR); more than 90% loss of tumor cells * grade 5: no malignant cells identifiable in sections from the site of the tumor; only vascular fibroelastonic stroma remains often containing macrophages (pCR) (however, ductal carcinoma in situ (DCIS) may be present)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
41 participants
Primary outcome timeframe
Up to 6 months
Results posted on
2021-02-16
Participant Flow
An additional arm (NIR/US - Crossover from Endocrine Cohort to Chemotherapy Cohort) was added for results reporting as one participant transitioned from the Endocrine Cohort to the Chemotherapy Cohort because the participant's therapy was changed mid-treatment from Endocrine to Chemotherapy.
Participant milestones
| Measure |
NIR/US (Neoadjuvant Chemotherapy Cohort)
Patients will have the NIR/US baseline scan performed before their first treatment. The desirable schedule will be \>= 7 days after initial biopsy to avoid confounding effects from the biopsy related acute inflammatory response.
* In addition, patients will also have NIR/US performed at end of cycle 1, end of cycle 2, end of cycle 3, end of cycle 5 (only if treatment regimen changed), and prior to surgery.
* The number of NIR/US study visits may vary (5-6) depending on the patient's treatment regimen
|
NIR/US (Neoadjuvant Endocrine Cohort)
Patients will have the NIR/US baseline scan performed before their first treatment. The desirable schedule will be \>= 7 days after initial biopsy to avoid confounding effects from the biopsy related acute inflammatory response.
* In addition, patients will also have NIR/US performed at end of cycle 1, end of cycle 2, end of cycle 3, at time of treatment regimen change (only intended for those who have had a change in their regimen), and prior to surgery.
* The number of NIR/US study visits may vary (5-6) depending on the patient's treatment regimen
|
NIR/US (Crossover From Endocrine Cohort to Chemotherapy Cohort)
Patients will have the NIR/US baseline scan performed before their first treatment. The desirable schedule will be \>= 7 days after initial biopsy to avoid confounding effects from the biopsy related acute inflammatory response.
* In addition, patients will also have NIR/US performed at end of cycle 1, end of cycle 2, end of cycle 3, at time of treatment regimen change (only intended for those who have had a change in their regimen), and prior to surgery.
* The number of NIR/US study visits may vary (5-6) depending on the patient's treatment regimen
|
|---|---|---|---|
|
Overall Study
STARTED
|
39
|
1
|
1
|
|
Overall Study
COMPLETED
|
36
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
1
|
Reasons for withdrawal
| Measure |
NIR/US (Neoadjuvant Chemotherapy Cohort)
Patients will have the NIR/US baseline scan performed before their first treatment. The desirable schedule will be \>= 7 days after initial biopsy to avoid confounding effects from the biopsy related acute inflammatory response.
* In addition, patients will also have NIR/US performed at end of cycle 1, end of cycle 2, end of cycle 3, end of cycle 5 (only if treatment regimen changed), and prior to surgery.
* The number of NIR/US study visits may vary (5-6) depending on the patient's treatment regimen
|
NIR/US (Neoadjuvant Endocrine Cohort)
Patients will have the NIR/US baseline scan performed before their first treatment. The desirable schedule will be \>= 7 days after initial biopsy to avoid confounding effects from the biopsy related acute inflammatory response.
* In addition, patients will also have NIR/US performed at end of cycle 1, end of cycle 2, end of cycle 3, at time of treatment regimen change (only intended for those who have had a change in their regimen), and prior to surgery.
* The number of NIR/US study visits may vary (5-6) depending on the patient's treatment regimen
|
NIR/US (Crossover From Endocrine Cohort to Chemotherapy Cohort)
Patients will have the NIR/US baseline scan performed before their first treatment. The desirable schedule will be \>= 7 days after initial biopsy to avoid confounding effects from the biopsy related acute inflammatory response.
* In addition, patients will also have NIR/US performed at end of cycle 1, end of cycle 2, end of cycle 3, at time of treatment regimen change (only intended for those who have had a change in their regimen), and prior to surgery.
* The number of NIR/US study visits may vary (5-6) depending on the patient's treatment regimen
|
|---|---|---|---|
|
Overall Study
Did not complete all timepoints in Endocrine Cohort
|
0
|
0
|
1
|
|
Overall Study
Developed metastases prior to completing neoadjuvant therapy
|
2
|
0
|
0
|
|
Overall Study
Taken off study after first imaging appointment
|
1
|
0
|
0
|
Baseline Characteristics
Ultrasound and Near Infrared Imaging for Predicting and Monitoring Neoadjuvant Treatment
Baseline characteristics by cohort
| Measure |
NIR/US (Neoadjuvant Chemotherapy Cohort)
n=39 Participants
Patients will have the NIR/US baseline scan performed before their first treatment. The desirable schedule will be \>= 7 days after initial biopsy to avoid confounding effects from the biopsy related acute inflammatory response.
* In addition, patients will also have NIR/US performed at end of cycle 1, end of cycle 2, end of cycle 3, end of cycle 5 (only if treatment regimen changed), and prior to surgery.
* The number of NIR/US study visits may vary (5-6) depending on the patient's treatment regimen
|
NIR/US (Neoadjuvant Endocrine Cohort)
n=1 Participants
Patients will have the NIR/US baseline scan performed before their first treatment. The desirable schedule will be \>= 7 days after initial biopsy to avoid confounding effects from the biopsy related acute inflammatory response.
* In addition, patients will also have NIR/US performed at end of cycle 1, end of cycle 2, end of cycle 3, at time of treatment regimen change (only intended for those who have had a change in their regimen), and prior to surgery.
* The number of NIR/US study visits may vary (5-6) depending on the patient's treatment regimen
|
NIR/US (Crossover From Endocrine Cohort to Chemotherapy Cohort)
n=1 Participants
Patients will have the NIR/US baseline scan performed before their first treatment. The desirable schedule will be \>= 7 days after initial biopsy to avoid confounding effects from the biopsy related acute inflammatory response.
* In addition, patients will also have NIR/US performed at end of cycle 1, end of cycle 2, end of cycle 3, at time of treatment regimen change (only intended for those who have had a change in their regimen), and prior to surgery.
* The number of NIR/US study visits may vary (5-6) depending on the patient's treatment regimen
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
45 years
n=5 Participants
|
66 years
n=7 Participants
|
53 years
n=5 Participants
|
45 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
38 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
39 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
41 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 6 monthsPopulation: For this outcome measure, the one participant who was in the crossover cohort was counted in the neoadjuvant chemotherapy cohort. Three participants in the neoadjuvant chemotherapy cohort were not evaluable for this outcome measure (2 developed metastases prior to completing neoadjuvant therapy and 1 was taken off study after first imaging appointment).
In the Miller-Payne system, the pathologic response is divided into 5 grades based on comparison of tumor cellularity between pre-neoadjuvant core biopsy and definitive surgical specimen as: * grade 1: no change or some alteration to individual malignant cells but no reduction in overall cellularity (pNR) * grade 2: a minor loss of tumor cells but overall cellularity still high; up to 30% (pPR) * grade 3: between an estimated 30% and 90% reduction in tumor cells (pPR) * grade 4: a marked disappearance of tumor cells such that only small clusters or widely dispersed individual cells remain (almost pCR); more than 90% loss of tumor cells * grade 5: no malignant cells identifiable in sections from the site of the tumor; only vascular fibroelastonic stroma remains often containing macrophages (pCR) (however, ductal carcinoma in situ (DCIS) may be present)
Outcome measures
| Measure |
NIR/US (Neoadjuvant Chemotherapy Cohort)
n=37 Participants
Patients will have the NIR/US baseline scan performed before their first treatment. The desirable schedule will be \>= 7 days after initial biopsy to avoid confounding effects from the biopsy related acute inflammatory response.
* In addition, patients will also have NIR/US performed at end of cycle 1, end of cycle 2, end of cycle 3, end of cycle 5 (only if treatment regimen changed), and prior to surgery.
* The number of NIR/US study visits may vary (5-6) depending on the patient's treatment regimen
|
NIR/US (Neoadjuvant Endocrine Cohort)
n=1 Participants
Patients will have the NIR/US baseline scan performed before their first treatment. The desirable schedule will be \>= 7 days after initial biopsy to avoid confounding effects from the biopsy related acute inflammatory response.
* In addition, patients will also have NIR/US performed at end of cycle 1, end of cycle 2, end of cycle 3, at time of treatment regimen change (only intended for those who have had a change in their regimen), and prior to surgery.
* The number of NIR/US study visits may vary (5-6) depending on the patient's treatment regimen
|
NIR/US (Crossover From Endocrine Cohort to Chemotherapy Cohort)
Patients will have the NIR/US baseline scan performed before their first treatment. The desirable schedule will be \>= 7 days after initial biopsy to avoid confounding effects from the biopsy related acute inflammatory response.
* In addition, patients will also have NIR/US performed at end of cycle 1, end of cycle 2, end of cycle 3, at time of treatment regimen change (only intended for those who have had a change in their regimen), and prior to surgery.
* The number of NIR/US study visits may vary (5-6) depending on the patient's treatment regimen
|
|---|---|---|---|
|
Pathologic Response Based on Miller-Payne Grading System
Grade 1
|
4 Participants
|
1 Participants
|
—
|
|
Pathologic Response Based on Miller-Payne Grading System
Grade 2
|
3 Participants
|
0 Participants
|
—
|
|
Pathologic Response Based on Miller-Payne Grading System
Grade 3
|
8 Participants
|
0 Participants
|
—
|
|
Pathologic Response Based on Miller-Payne Grading System
Grade 4
|
3 Participants
|
0 Participants
|
—
|
|
Pathologic Response Based on Miller-Payne Grading System
Grade 5
|
19 Participants
|
0 Participants
|
—
|
Adverse Events
NIR/US (Neoadjuvant Chemotherapy Cohort)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
NIR/US (Neoadjuvant Endocrine Cohort)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
NIR/US (Crossover From Endocrine Cohort to Chemotherapy Cohort)
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
Quing Zhu, Ph.D.
Washington University School of Medicine
Phone: 314-935-7519
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place