Randomized Trial Standard of Care Vascular Access Strategies for (Neo)Adjuvant Trastuzumab-based Breast Cancer Treatment. (OTT 15-06)

Ottawa Hospital Research Institute

Status: Completed

Conditions: Breast Cancer; Cancer

Treatments: Device: PORT; Device: PICC

Study type: Interventional

Funder types: Other

Identifiers

NCT02632435

15-089

Details and patient eligibility

About

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).

Enrollment: 56 patients

Sex: Female

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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56 participants in 2 patient groups

Peripherally inserted central catheter

Other group

Description:

PICC line will be inserted for the delivery and duration of chemotherapy.

Treatment:

Device: PICC

portacath

Other group

Description:

PORT will be inserted for the delivery and duration of chemotherapy and trastuzumab.

Treatment:

Device: PORT