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

Sponsor
University of Washington (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03738553
Collaborator
(none)
13
Enrollment
1
Location
145
Anticipated Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

Detailed 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.

Study Design

Study Type:
Observational
Actual Enrollment :
13 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Multiparametric MRI for Assessing Breast Cancer Response to Anti-HER2 Therapy
Actual Study Start Date :
Aug 1, 2013
Actual Primary Completion Date :
Sep 1, 2020
Anticipated Study Completion Date :
Sep 1, 2025

Outcome Measures

Primary Outcome Measures

  1. Tumor infiltrating lymphocytes (TILs) [10 years]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Inclusion Criteria:

  • Women 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Seattle Cancer Care Alliance Seattle Washington United States 98109

Sponsors and Collaborators

  • University of Washington

Investigators

  • Principal Investigator: Savannah Partridge, Fred Hutch/University of Washington Cancer Consortium

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Savannah Partridge, Professor, University of Washington
ClinicalTrials.gov Identifier:
NCT03738553
Other Study ID Numbers:
  • 7889
  • RG3013002
First Posted:
Nov 13, 2018
Last Update Posted:
Mar 18, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Breast Neoplasms
Trastuzumab

Study Results

No Results Posted as of Mar 18, 2022