Clinical trial · Interventional
REaCT-vascular Access Her2 Negative Vascular Access Strategies for (Neo) Adjuvant Breast Cancer Treatment Without Trastuzumab
Simple, Prospective and Randomized Trial to Obtain Answers to Questions of Standard of Care: Vascular Access Strategies for (Neo) Adjuvant Breast Cancer Treatment Without Trastuzumab: A Study From the REthinking Clinical Trials Program (REaCT-vascular Access Her2 Negative).
- 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 Her2 negative study, 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. Determining the optimal vascular access strategy remains an important medical issue for patients, nurses, physicians and society. A novel method to allow comparison of established standards of care is needed as part of an increasing internationally mandated incentive to perform more pragmatic clinic trials.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| venous access PORT or PICC | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Venous access PORT or PICC
- description
- Participants will receive a central line placement either a PORT or a PICC prior to the initiation of chemotherapy.
- interventionNames
- Device: venous access PORT or PICC
- type
- NO_INTERVENTION
- label
- No intervention
- description
- Participants will only receive a central line if required once chemotherapy has been initiated.
Primary outcomes (2)
- measure
- Accrual rates
- timeFrame
- One year
- description
- Percentage of patients who receive (neo)adjuvant IV systemic therapy for Her 2 negative breast cancer compared to the number of participants who agree to randomization. The total number of new patients receiving (neo) adjuvant IV systemic cytotoxic therapy will be provided by the local chemotherapy pharmacy and Oncology Patient Information System records.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed primary breast cancer * Planned to start either FEC-D, AC-D, dose-dense AC-T, TAC, or TC chemotherapy, in the adjuvant or neoadjuvant setting. * ≥19 years of age * Able to provide verbal consent Exclusion Criteria: • Contraindication to central line placement.
References
Publications (1)
- DERIVEDRobinson A, Stober C, Fergusson D, Kehoe A, Bedard D, MacDonald F, Brunet MC, Saunders D, Mazzarello S, Vandermeer L, Joy AA, Awan A, Basulaiman B, Mallick R, Hutton B, Clemons M; REaCT investigators. A multicentre, randomized pilot trial comparing vascular access strategies for early stage breast cancer patients receiving non-trastuzumab containing chemotherapy. Breast Cancer Res Treat. 2019 Nov;178(2):337-345. doi: 10.1007/s10549-019-05388-5. Epub 2019 Aug 7. PMID 31392518