Breast Cancer, Breast Tumors, Cancer of Breast, Cancer of the Breast, Malignant Neoplasm of Breast
Conditions
Brief summary
To determine the accuracy of NIR/US assessment of tumor vasculature and oxygen changes in predicting and monitoring early neoadjuvant treatment response compared to pathological response.
Interventions
DEVICEOptical Tomography Using Near Infrared Diffused Light Assisted with Ultrasound
Sponsors
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Washington University School of Medicine
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Scheduled to receive neoadjuvant chemotherapy for the treatment of newly diagnosed, locally advanced breast cancer or scheduled to receive neoadjuvant endocrine therapy with the eventual goal of surgery of newly diagnosed clinical stage II-III ER+ HER2- breast cancer (for the endocrine therapy cohort) * At least 18 years of age * Female * Able to understand and willing to sign an IRB-approved written informed consent document
Exclusion criteria
* Pregnant and/or breastfeeding * Prior history of breast cancer * Prior history of chest wall radiation * Prior history of breast reconstruction, reduction, or augmentation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathologic Response Based on Miller-Payne Grading System | Up to 6 months | 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) |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 39 |
| 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 | 1 |
| 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 | 1 |
| Total | 41 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Developed metastases prior to completing neoadjuvant therapy | 2 | 0 | 0 |
| Overall Study | Did not complete all timepoints in Endocrine Cohort | 0 | 0 | 1 |
| Overall Study | Taken off study after first imaging appointment | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | NIR/US (Neoadjuvant Chemotherapy Cohort) | Total | NIR/US (Crossover From Endocrine Cohort to Chemotherapy Cohort) | NIR/US (Neoadjuvant Endocrine Cohort) |
|---|---|---|---|---|
| Age, Continuous | 45 years | 45 years | 53 years | 66 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 38 Participants | 40 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 10 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 31 Participants | 31 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 39 participants | 41 participants | 1 participants | 1 participants |
| Sex: Female, Male Female | 39 Participants | 41 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 39 | 0 / 1 | 0 / 1 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 39 | 0 / 1 | 0 / 1 |
Outcome results
Primary
Pathologic Response Based on Miller-Payne Grading System
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)
Time frame: Up to 6 months
Population: 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).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| NIR/US (Neoadjuvant Chemotherapy Cohort) | Pathologic Response Based on Miller-Payne Grading System | Grade 3 | 8 Participants |
| NIR/US (Neoadjuvant Chemotherapy Cohort) | Pathologic Response Based on Miller-Payne Grading System | Grade 4 | 3 Participants |
| NIR/US (Neoadjuvant Chemotherapy Cohort) | Pathologic Response Based on Miller-Payne Grading System | Grade 2 | 3 Participants |
| NIR/US (Neoadjuvant Chemotherapy Cohort) | Pathologic Response Based on Miller-Payne Grading System | Grade 5 | 19 Participants |
| NIR/US (Neoadjuvant Chemotherapy Cohort) | Pathologic Response Based on Miller-Payne Grading System | Grade 1 | 4 Participants |
| NIR/US (Neoadjuvant Endocrine Cohort) | Pathologic Response Based on Miller-Payne Grading System | Grade 5 | 0 Participants |
| NIR/US (Neoadjuvant Endocrine Cohort) | Pathologic Response Based on Miller-Payne Grading System | Grade 1 | 1 Participants |
| NIR/US (Neoadjuvant Endocrine Cohort) | Pathologic Response Based on Miller-Payne Grading System | Grade 2 | 0 Participants |
| NIR/US (Neoadjuvant Endocrine Cohort) | Pathologic Response Based on Miller-Payne Grading System | Grade 4 | 0 Participants |
| NIR/US (Neoadjuvant Endocrine Cohort) | Pathologic Response Based on Miller-Payne Grading System | Grade 3 | 0 Participants |