REaCT-vascular Access Her2 Negative Vascular Access Strategies for (Neo) Adjuvant Breast Cancer Treatment Without Trastuzumab (OTT 15-07)

Ottawa Hospital Research Institute

Status: Completed

Conditions: Breast Cancer; Cancer

Treatments: Device: venous access PORT or PICC

Study type: Interventional

Funder types: Other

Identifiers

NCT02688998

20160006-01H

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: Female

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Venous access PORT or PICC

Active Comparator group

Description:

Participants will receive a central line placement either a PORT or a PICC prior to the initiation of chemotherapy.

Treatment:

Device: venous access PORT or PICC

No intervention

No Intervention group

Description:

Participants will only receive a central line if required once chemotherapy has been initiated.