Breast Cancer, HER2-negative Breast Cancer, HER2-positive Breast Cancer, Invasive Breast Carcinoma, TNBC - Triple-Negative Breast Cancer
Conditions
Keywords
neoadjuvant chemotherapy, breast cancer, imaging, NearWave, invasive breast cancer
Brief summary
The purpose of this study is to assess the feasibility of the NearWave optical molecular monitoring system for monitoring therapy progression and predicting pathologic complete response (pCR) of breast cancer patients undergoing neoadjuvant chemotherapy (NAC).
Detailed description
This is a prospective, observational, pilot study. Due to the investigational nature of the NearWave device, imaging data collected will not be used to inform patient treatment. Since this is our first experience with the NearWave device and there does not exist any preliminary data with this device, we are performing this pilot study to establish whether data collected is of high enough quality to warrant further study. Primary Objective: The primary objective of this study is to assess the feasibility of using the NearWave optical molecular monitoring system during therapy to predict pCR in breast cancer patients undergoing NAC, measured by the data quality captured with the device.
Interventions
DEVICENearWave monitoring
NearWave optical molecular monitoring
Sponsors
Indiana University
University of Notre Dame
Elevate Ventures
NearWave Corp.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Women ≥ 18 years old at the time of informed consent 2. Ability to provide written informed consent and HIPAA authorization 3. Patients who: 1. have been diagnosed with invasive breast cancer by tissue biopsy and have not yet started any therapy for the disease; a) Subtype HER2 positive (IHC 3+ or if IHC 2+, then positive by FISH), with any ER status, OR b) Subtype TNBC, defined by: HER2 negative and ER/PR negative or low (ER and PR ≤ 9%, weak staining) 2. with ≥2 cm tumor size in the largest dimension as measured by ultrasound, MRI, or mammography. If multifocal disease, at least one tumor must measure ≥2 cm 3. are planned to receive neoadjuvant chemotherapy followed by surgery 4. Will be at least two weeks out from biopsy of the primary lesion at the time of baseline visit 5. Have a palpable breast mass as determined by a treating physician
Exclusion criteria
1. Patients with significant bruising or hematoma from diagnostic breast biopsy, as determined by clinical judgement (mild ecchymosis okay) 2. Inflammatory breast cancer 3. Prior breast cancer requiring surgery or radiation in either breast 4. Pregnant or nursing due to changes in breast architecture 5. Patients with a BMI of ≥ 40, unless the lesion is near the surface (\<3 cm from the skin surface), based on diagnostic scan measurements 6. Patients with any tattoos on their breasts
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of using NearWave imaging as a monitoring system | Over approximately 5 months; baseline, mid way through treatment, and at last dose of clinical chemotherapy/prior to clinical surgery | Adequate data quality metrics: Signal-to-noise ratio (SNR) (measurement that compares the strength of a signal to the level of background noise) above 10 dB for at least 80% of collected data points; |
Countries
United States
Contacts
CONTACTTarah J Ballinger, MD
CONTACTXin Bryan, RN
Outcome results
None listed