RecruitingNot ApplicableNCT06744465

NearWave Optical Molecular Monitoring

NearWave Optical Molecular Monitoring for Predicting Complete Pathological Response (pCR) to Neoadjuvant Chemotherapy (NAC) in Breast Cancer Patients

Sponsor

Indiana University

Enrollment

15 participants

Start Date

Mar 7, 2025

Study Type

INTERVENTIONAL

Conditions

Breast Cancer HER2-negative Breast Cancer HER2-positive Breast Cancer TNBC - Triple-Negative Breast Cancer Invasive Breast Carcinoma

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).

Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria8

Women ≥ 18 years old at the time of informed consent
Ability to provide written informed consent and HIPAA authorization
Patients who:
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)
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
are planned to receive neoadjuvant chemotherapy followed by surgery
Will be at least two weeks out from biopsy of the primary lesion at the time of baseline visit
Have a palpable breast mass as determined by a treating physician

Exclusion Criteria6

Patients with significant bruising or hematoma from diagnostic breast biopsy, as determined by clinical judgement (mild ecchymosis okay)
Inflammatory breast cancer
Prior breast cancer requiring surgery or radiation in either breast
Pregnant or nursing due to changes in breast architecture
Patients with a BMI of ≥ 40, unless the lesion is near the surface (\<3 cm from the skin surface), based on diagnostic scan measurements
Patients with any tattoos on their breasts