Monitoring Response to Neoadjuvant Chemotherapy in HER2 Negative Breast Cancer Using High-speed MR Spectroscopic Imaging

NCT03568448 | Active Not Recruiting

• 1 other identifier: INST 1607
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The study will assess whether changes in total choline concentration \[tCho\] during neoadjuvant chemotherapy (NAC) are predictive of pathologic complete response (pCR) in patients with HER2 negative breast cancer (HNBC) appropriate for NAC, and compare these findings with dynamic contrast enhanced magnetic resonance imaging (DCE-MRI). The objective is to assess the predictive value of changes in the concentration and spatial extent of tCho within the tumor during NAC.

Conditions

HER2 Negative Breast Cancer

Keywords

HER2 negative breast cancer

Outcome Measures

Primary Outcomes (1)

• Assess the correlation of serial high-speed MRSI of [tCho] with pCR following NAC

  In this study changes in total choline concentration \[tCho\] during neoadjuvant chemotherapy (NAC) will be evaluated by performing a high-speed magnetic resonance spectroscopic imaging (MRSI) at baseline prior to first cycle NAC, after first cycle NAC, and prior to second cycle NAC.

  Patient will begin participation 2 weeks prior to initiation of NAC and will complete participation at the time of surgery, estimated to be 4-6 months total participation duration.

Secondary Outcomes (2)

• Assess the correlation of serial high-speed MRSI of [tCho] with response to NAC

  Patient will begin participation 2 weeks prior to initiation of NAC and will complete participation at the time of surgery, estimated to be 4-6 months total participation duration.

• Compare the time course of [tCho] on serial high-speed MRSI and tumor volume on serial DCE-MRI for predicting early NAC treatment response

  Patient will begin participation 2 weeks prior to initiation of NAC and will complete participation at the time of surgery, estimated to be 4-6 months total participation duration.

Interventions

Response monitoring (no intervention) OTHER

Response monitoring (no intervention)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Eligible female breast cancer patients receiving treatment at the University of New Mexico Comprehensive Cancer Center.

You may qualify if:

• Have a biopsy proven HER2 negative (by IHC or FISH) breast cancer per standard clinical criteria (per ASCO-CAP guidelines). Although patients with hormone-receptor positive (ER+ and/or PR+) disease will be included, patients with tumor features indicative of luminal A intrinsic sub-type will be excluded from this study. Excluding features are:
• Patients with Grade 1 breast cancers, as assessed by local standard criteria, will be excluded from participation.
• Patients with strongly ER AND PR positive breast cancer, defined as \>75% positive staging for BOTH markers by IHC, will be excluded from participation.
• Stage of disease that is appropriate for standard NAC (any combination of T2 to T4, N0 to N3 that would comprise stage IIA to IIIB disease). Patients with inflammatory carcinoma or stage IIIC disease who are deemed inoperable at the outset, but appropriate for NAC are excluded in this study since there is no guarantee they can be converted to operability following NAC; thus precluding assessment of pCR.
• Medically fit for NAC as per good clinical practice and per the treating physician's judgment.
• Age \> or = to 18 years AND able to provide informed consent.
• Women of childbearing potential must be willing and able to use effective means of contraception. A female of childbearing potential is any woman who has not undergone a hysterectomy or bilateral oophorectomy or has not had menses at any time in the preceding 12 consecutive months.
• Able to undergo standard clinical MRI exams PLUS additional 30 minutes longer (total scan time is 50 to 60 minutes).

You may not qualify if:

• Pregnant or lactating women.
• Body contains foreign items posing an issue of MRI safety, such as intra-ocular metallic foreign bodies, MRI incompatible devices such as pacemakers and cochlear implants, and other MRI incompatible devices.
• Obesity (Body Mass Index \[BMI\] \> 40) or inability to fit into the standard MRI gantry.
• Suffer from back pain, claustrophobia, seizures, panic disorder and/or other medical disorders severe enough that would prevent them from completing a standard clinical MRI study (30 min) + 30 mins for the research scans. If applicable, patients may take a mild anxiolytic (e.g., lorazepam) if deemed appropriate by their treating physician.
• Patients with stage IV disease (gross metastasis or documented M1 disease) and stage of disease excluded above.

Sponsors & Collaborators

• New Mexico Cancer Research Alliance: lead

Study Sites (1)

University of New Mexico Comprehensive Cancer Center

Albuquerque, New Mexico, 87131, United States

Location

Study Officials

• Stefan Posse, PhD

  University of New Mexico Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2018
• First Posted: June 26, 2018
• Study Start: April 16, 2018
• Primary Completion: January 22, 2020
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)