Pegfilgrastim for Breast Cancer

Thunder Bay Regional Health Sciences Centre, Thunder Bay, Canada
Breast CancerFilgrastim - Drug
All Sexes
What conditions do you have?

Study Summary

This trial will compare the amount of bone pain experienced by breast cancer patients who receive a single dose of Pegfilgrastim to those who receive 5 doses of daily filgrastim while undergoing neoadjuvant/adjuvant chemotherapy.

Eligible Conditions
  • Breast Cancer

Treatment Effectiveness

Phase-Based Effectiveness

3 of 3
Phase 4
This is further along than 93% of similar trials

Study Objectives

1 Primary · 10 Secondary · Reporting Duration: 5 days after first G-CSF injection

Year 1
Study feasibility
Year 5
Differences in healthcare resource utilization
Incidence of Febrile Neutropenia
Incidence of chemotherapy alteration
Incidence of chemotherapy-related mortality
Incidence of treatment-related hospitalizations
Patient G-CSF preference
Rate of G-CSF compliance as prescribed
Day 5
Bone pain

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2 Treatment Groups

1 of 2
5 Days of Filgrastim
1 of 2

Active Control

233 Total Participants · 2 Treatment Groups

Primary Treatment: Pegfilgrastim · No Placebo Group · Phase 4

ActiveComparator Group · 1 Intervention: Pegfilgrastim · Intervention Types: Drug
5 Days of Filgrastim
ActiveComparator Group · 1 Intervention: Filgrastim · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 5 days after first g-csf injection

Who is running the clinical trial?

Ottawa Hospital Research InstituteLead Sponsor
544 Previous Clinical Trials
2,517,774 Total Patients Enrolled
34 Trials studying Breast Cancer
5,273 Patients Enrolled for Breast Cancer
Terry Ng, MDPrincipal InvestigatorOttawa Hospital Research Institute
1 Previous Clinical Trials
240 Total Patients Enrolled
1 Trials studying Breast Cancer
240 Patients Enrolled for Breast Cancer

Eligibility Criteria

Age 18+ · All Participants · 0 Total Inclusion Criteria

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Frequently Asked Questions

How many participants are the maximum capacity for this experiment?

"Affirmative, the information hosted on shows that this medical study is still recruiting participants. The trial was first posted on June 9th 2021 and most recently edited November 5th 2022; 232 people are required from two different sites." - Anonymous Online Contributor

Unverified Answer

Are volunteers still being recruited for this investigation?

" affirms that recruitment is in progress for this medical experiment, which was posted on June 9th 2021 and adjusted as recently as November 5th 2022." - Anonymous Online Contributor

Unverified Answer

What potential hazards have been associated with the use of Pegfilgrastim?

"There is already regulatory approval for Pegfilgrastim, which has been granted a safety score of 3." - Anonymous Online Contributor

Unverified Answer

What conditions do physicians typically prescribe Pegfilgrastim to treat?

"Pegfilgrastim is most commonly administered to alleviate severe congenital neutropenia, though it may also provide relief from acute leukemia and other malignant neoplasms." - Anonymous Online Contributor

Unverified Answer

To what extent has Pegfilgrastim been utilized in other clinical experiments?

"Currently, 172 trials are underway that involve Pegfilgrastim. 40 of these studies have advanced to the third and final phase while 5807 sites across the world are running tests regarding this drug's efficacy. The majority of clinical research is taking place in Saint Louis, Missouri." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.