Clinical trial · Observational
Multiparametric MRI for Assessing Breast Cancer Response to Anti-HER2 Therapy
NCT03738553CI-TRIAL-00110272terminatedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study closed to accrual after meeting grant enrollment goal, prior to reaching protocol accrual goal, due to end of funding.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HER2-positive Breast Cancer | HER2-Positive Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRI | Device | — | UNRESOLVED |
| Trastuzumab | Drug | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Tumor infiltrating lymphocytes (TILs)
- timeFrame
- 10 years
- description
- 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
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.