| NCT ID | NCT06744465 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Indiana University |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2025-03-07 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 15 participants in total. It began in 2025-03-07 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06744465 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06744465 currently recruiting?
Yes, NCT06744465 is actively recruiting participants. Contact the research team at tarahb@iu.edu for enrollment information.
Where is the NCT06744465 trial being conducted?
This trial is being conducted at Indianapolis, United States.
Who is sponsoring the NCT06744465 clinical trial?
NCT06744465 is sponsored by Indiana University. The trial plans to enroll 15 participants.
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