Clinical trial · Interventional
Randomized Trial Standard of Care Vascular Access Strategies for (Neo)Adjuvant Trastuzumab-based Breast Cancer Treatment.
A Pragmatic Randomized Trial Standard of Care Vascular Access Strategies for (Neo)Adjuvant Trastuzumab-based Breast Cancer Treatment OTT 15-06 A Study From the REthinking Clinical Trials Program (REaCT-vascular Access Trastuzumab Study).
- 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)
In the REaCT-Vascular Access Trastuzumab study (REaCT-VA), the investigator will use a novel method to allow comparisons of established standard of care vascular access strategies using the "integrated consent model" as part of a pragmatic clinical trial. The investigator wishes to address a non-pharmacologic issue regarding standard of care vascular access devices. Peripherally inserted central catheters (PICC lines) versus subcutaneously implanted devices (PORTs).
Conditions
Conditions (2)
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 |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PICC | Device | — | UNRESOLVED |
| PORT | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Peripherally inserted central catheter
- description
- PICC line will be inserted for the delivery and duration of chemotherapy.
- interventionNames
- Device: PICC
- type
- OTHER
- label
- portacath
- description
- PORT will be inserted for the delivery and duration of chemotherapy and trastuzumab.
- interventionNames
- Device: PORT
Primary outcomes (2)
- measure
- Accrual rates
- timeFrame
- one year
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria * Histologically confirmed primary breast cancer * Planned to start trastuzumab based neo/adjuvant therapy: FEC-DH or AC-DH, or; dose-dense AC-TH, or docetaxel/cyclophosphamide/trastuzumab or docetaxel/carboplatin/trastuzumab, or weekly paclitaxel with trastuzumab. * ≥19 years of age * Able to provide verbal consent Exclusion Criteria • Contraindication to central line placement.
References
Publications (1)
- DERIVEDClemons M, Stober C, Kehoe A, Bedard D, MacDonald F, Brunet MC, Saunders D, Vandermeer L, Mazzarello S, Awan A, Basulaiman B, Robinson A, Mallick R, Hutton B, Fergusson D. A randomized trial comparing vascular access strategies for patients receiving chemotherapy with trastuzumab for early-stage breast cancer. Support Care Cancer. 2020 Oct;28(10):4891-4899. doi: 10.1007/s00520-020-05326-y. Epub 2020 Jan 30. PMID 32002617