Neoadjuvant Therapy and Contrast-enhanced Mammography for Early Stage Breast Cancer

Early Phase 1

Recruiting

• Conditions: TNBC, Triple Negative Breast Cancer; HER2-positive Breast Cancer; Breast Cancer; Locally Advanced Breast Cancer; Neoadjuvant Chemotherapy; Triple Negative Breast Cancer
• Interventions: Diagnostic Test: CEDM; Diagnostic Test: CEDBT; Drug: Omnipaque 350mgI/mL Solution for Injection

• Registration Number: NCT06220214
• Lead Sponsor: Alison Stopeck

Brief Summary

The purpose of this study is to compare a special type of mammogram that uses a contrast agent called contrast-enhanced digital mammography with contrast-enhanced digital breast tomosynthesis (CEDM+CEDBT), with breast magnetic resonance imaging imaging (MRI) for predicting the effect of neoadjuvant chemotherapy on pathologic complete response rates. The device used to obtain CEDM+CEDBT images is called Siemens MAMMOMAT. This device produces two-dimensional (2D) images, as in a normal mammogram, but also collects additional images for digital breast tomosynthesis (DBT), which produces a three-dimensional (3D) image of the breast in the form of image slices. DBT allows the radiologist to "see through" the breast tissue for better detection and localization of breast cancer. By looking at both the CEDM images and the CEDBT images, a radiologist may be able to better detect residual breast cancer in a more cost-effective manner.

Participation may last up to 18 weeks.

Study procedures for this research are:

* Undergoing 1-2 mammograms during and/or after your chemotherapy, but before primary breast surgery.

* Before each mammogram, have a radiology technician inject a liquid contrast agent by inserting a needle into a vein. The chemotherapy port cannot be used to receive the contrast agent

* Let the research team record information from your medical record related to your condition and the treatment you receive.

* Give permission to collect leftover tissue from your diagnostic biopsy and breast surgery.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-05
• Study First Submitted QC: 2024-01-22
• Study First Posted: 2024-01-23
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-05
• Last Update Posted: 2024-03-07
• Study Start: 2024-03-23
• Primary Completion: 2026-07-31
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• Diagnosis with either type of invasive locally advanced breast cancer regardless of hormone receptor or Her2 status
• Plan to receive at least 4 cycles of neoadjuvant chemotherapy ahead of definitive surgery

Exclusion Criteria

• Pregnancy
• Allergy/sensitivity to contrast agent
• Decreased kidney function
• Diabetes

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CEDM + CEDBT	CEDBT	Participants undergo CEDM + CEDBT imaging after every 4-6 cycles of neoadjuvant chemotherapy prior to surgery (imaging may occur up to 2 times)
CEDM + CEDBT	CEDM	Participants undergo CEDM + CEDBT imaging after every 4-6 cycles of neoadjuvant chemotherapy prior to surgery (imaging may occur up to 2 times)
CEDM + CEDBT	Omnipaque 350mgI/mL Solution for Injection	Participants undergo CEDM + CEDBT imaging after every 4-6 cycles of neoadjuvant chemotherapy prior to surgery (imaging may occur up to 2 times)

Primary Outcome Measures

Name	Time	Method
Accuracy of (CEDM+CEDBT) to predict NAC treatment effects	Immediately after definitive breast surgery, up to 24 weeks	The ability of CEDM + CEDBT to predict pathologic complete response to neoadjuvant chemotherapy, determined by histopathology evaluation of the resected breast

Secondary Outcome Measures

Name	Time	Method
Accuracy of (CEDM+CEDBT) to detect residual tumor compared with standard of care MRI	Immediately before definitive breast surgery	Concordance between CEDM + CEDBT and standard of care MRI in quantifying residual tumor size

Trial Locations

Locations (1)

Stony Brook Breast Center; 🇺🇸 Stony Brook, New York, United States