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

O

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)

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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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