Clinical trial · Interventional
A Feasibility Study for Women Receiving Anthracycline Chemotherapy With or Without Radiation for HER2-neu Positive Invasive Ductal Carcinoma
A Feasibility Study for Women Receiving Adjuvant or Neo-adjuvant Anthracycline Chemotherapy With or Without Radiation for HER2-neu Positive Invasive Ductal Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this project is to assess the feasibility of collecting plasma samples for cardiac biomarker assessment, and to identify if there is an associations between the biomarkers, echocardiographic features and the cardiac PET scan results (in patients receiving radiation therapy). This is the first step in a research program that has an overall goal of being able to predict early-treatment induced cardiotoxicity in patients with breast cancer.
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Feasibility study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Feasibility study
- description
- All participants will have blood draws for biomarkers during the course of the study at visit 1, 2, 3, 4, 5, 6, 7 and 8. they will also have the speckle tracking echocardiogram at visit 1, 4, 5, 6, 7 and 8. For women 45 an over a cardiac PET scan will be performed at visit 1 and 5.
- interventionNames
- Other: Feasibility study
Primary outcomes (1)
- measure
- Recruitment rates
- timeFrame
- every 4 weeks up to 2 years
Secondary outcomes (1)
- measure
- Cardiotoxicity
- timeFrame
- Once when the last participant completes week 57
- description
- To measure biomarkers, myocardial perfusion, cardiac adverse events and peak systolic longitudinal strain.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: 1. Stage I-III, HER2-neu positive invasive ductal carcinoma 2. Scheduled to receive adjuvant/neo-adjuvant 5-Fluorouracil, Epirubicin, Cyclophosphamide and Docetaxel (FEC-D) chemotherapy 3. Scheduled to receive adjuvant Trastuzumab 4. ECOG Performance status 0-2 5. Adequate baseline imaging on transthoracic echocardiography, and baseline cardiac ejection fraction of ≥ 55%. Additionally, breast cancer patients≥45 years of age and scheduled to receive whole breast radiation therapy will receive two cardiac PET scans. Exclusion Criteria: 1. Prior anthracycline chemotherapy 2. History of dilated cardiomyopathy, congestive heart failure, or coronary artery disease 3. Life expectancy less than 15 months 4. Pregnant or lactating women 5. Use of beta receptor antagonists, calcium channel antagonists, angiotensin converting enzyme inhibitors, or angiotensin receptor inhibitors at baseline. 6. Previous chest wall/breast or nodal radiation.
References
Publications (0)
Data not yet available