Multiparametric MRI for Assessing Breast Cancer Response to Anti-HER2 Therapy

HER2-positive Breast Cancer Clinical Trial

Official title:

Multiparametric MRI for Assessing Breast Cancer Response to Anti-HER2 Therapy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03738553
• Other study ID #: 7889
• Secondary ID: RG3013002
• Status: Active, not recruiting
• Start date: August 2013
• Est. completion date: September 2025

Study information

• Verified date: December 2023
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a single institution, observational research study in which patients are observed using DWI/DCE MRI imaging before and after receiving neoadjuvant anti-HER2 therapy.

Description:

This is not a treatment trial. Patients will be treated according to the plan developed by their medical oncologists. Only patients planning to receive anti-HER2 therapy as part of planned systemic therapy will be eligible for this imaging study. Patients and their referring oncologist will be asked to start the anti-HER2 therapy 2-3 weeks prior to surgery and after the pre-therapy MRI.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 13
• Est. completion date: September 2025
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects at least 18 years of age.

• Have a new diagnosis of invasive breast cancer, clinical stage I - III, HER2 positive.

• Planning to undergo surgical resection plus adjuvant therapy to include an anti-HER2 agent.

• Have tissue block available for review of experimental markers.

• Be a candidate for MRI imaging.

• Be willing to comply with scheduled visits required for the trial.

• Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

• Recent therapy for breast cancer prior to baseline MRI.

• Subjects may not receive other investigational agents during the study window for imaging.

• Contraindications for MRI or MRI contrast including severe claustrophobia, history of previous reaction to MRI contrast, renal disease, congestive heart failure, other significant systemic diseases or any metal in their body, including but not limited to: a brain aneurysm clip, implanted neural stimulator, implanted cardiac pacemaker or defibrillator, cochlear implant, ocular foreign body (e.g. metal shavings), other implanted medical devices: (e.g. Swan Ganz catheter), insulin pump, metal shrapnel or bullet.

• Pregnant or nursing.

Related Conditions & MeSH terms

• Breast Neoplasms
• HER2-positive Breast Cancer

Intervention

Device:
• MRI
Diffusion Weighted Imaging and Dynamic Contrast enhanced MRI

Drug:
• Trastuzumab
Single dose of Trastuzumab prior to surgery

Locations

Country	Name	City	State
United States	Seattle Cancer Care Alliance	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor infiltrating lymphocytes (TILs)	Determine whether early changes on MRI reflect the level of immune response (based on TILs) in the tumor as measured by histologic assessment after 1 cycle of anti-HER2 treatment	10 years