Evaluating Omission of Granulocyte Colony-stimulating Factors in Breast Cancer Patients Receiving Paclitaxel Portion of Dose-dense Adriamycin-cyclophosphamide and Paclitaxel Chemotherapy

Recruiting Phase 4 Interventional Study
Early-stage Breast Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
242 (estimated)
Sponsor
Ottawa Hospital Research Institute · Other
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About This Trial
The goal of this randomized, pragmatic clinical trial is to evaluate the omission of granulocyte colony-stimulating factors (G-CSF) in breast cancer patients receiving paclitaxel portion of dose-dense adriamycin-cyclophosphamide and paclitaxel (DD-AC/T) chemotherapy. Participants will be randomized to either take G-CSF while on the paclitaxel portion of DD-AC/T chemotherapy or to omit G-CSF while …
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Patients with early-stage or locally-advanced breast cancer receiving neoadjuvant or adjuvant DD-AC/T chemotherapy requiring primary febrile neutropenia prophylaxis with G-CSF * Able to provide verbal consent * Able to complete questionnaires in English or French Exclusion Cr…
Contacts

Lisa Vandermeer, MSc

613-737-7700

lvandermeer@ohri.ca

CONTACT

Carol Stober

613-737-7700

cstober@toh.ca

CONTACT