Pegfilgrastim for Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to understand how women with non-metastatic breast cancer experience pain during chemotherapy treatment with pegfilgrastim, a medication used to prevent infection during chemo. Researchers seek to determine if younger women report more frequent or intense pain compared to older women. Participants are divided into two groups: those 45 years or younger and those over 45. Women diagnosed with invasive breast cancer, set to receive chemo and pegfilgrastim, and without chronic pain conditions are suitable for this study. As a Phase 2 trial, this research measures how well the treatment works in an initial, smaller group, offering participants a chance to contribute to important findings.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does exclude those taking chronic narcotics. It's best to discuss your specific medications with the study doctor.
Is there any evidence suggesting that pegfilgrastim is likely to be safe for humans?
Research has shown that pegfilgrastim is generally safe. Studies indicate it is particularly safe for short-term use. Although rare, some serious side effects have occurred, but these affect only a small number of cases. Importantly, no major safety differences have been found between adults and children using pegfilgrastim, suggesting it is well-tolerated across different age groups. The FDA has also approved pegfilgrastim for other uses, supporting its safety.12345
Why are researchers excited about this trial?
Pegfilgrastim is unique because it helps reduce the risk of infection in breast cancer patients by boosting white blood cell production. Unlike standard chemotherapy treatments that can lower white blood cell counts, pegfilgrastim specifically targets and enhances the growth of neutrophils, a type of white blood cell crucial for fighting infections. Researchers are excited about pegfilgrastim because it offers a targeted approach that not only supports the immune system during cancer treatment but also potentially reduces the need for hospitalization due to infections. This makes managing side effects of cancer treatment more effective and improves the overall quality of life for patients.
What evidence suggests that pegfilgrastim might be an effective treatment for pain management during chemotherapy?
Research has shown that pegfilgrastim lowers the risk of febrile neutropenia, a fever caused by low white blood cell counts, in patients undergoing chemotherapy. One study found that pegfilgrastim reduced the chance of febrile neutropenia by 94% compared to a placebo. Another study demonstrated that a single injection of pegfilgrastim was as effective as multiple daily injections of an older treatment, filgrastim, during chemotherapy cycles. Pegfilgrastim can be administered using different methods, such as an on-body injector or a prefilled syringe, both of which are equally effective in preventing issues from low white blood cell counts. Clinical data strongly supports the effectiveness of this treatment in managing chemotherapy side effects. Participants in this trial will be divided into two groups based on age, with both groups receiving pegfilgrastim to evaluate its effectiveness across different age ranges.678910
Who Is on the Research Team?
Julie Fisher, MD
Principal Investigator
Wake Forest University Health Sciences
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Chemotherapy Treatment
Participants receive chemotherapy treatment along with pegfilgrastim (or biosimilar substitution) to manage white blood cell counts.
Pain Monitoring
Participants self-report pain using ESAS scores over the course of one week following each dose of pegfilgrastim.
Follow-up
Participants are monitored for safety and effectiveness after the last administration of pegfilgrastim.
What Are the Treatments Tested in This Trial?
Interventions
- pegfilgrastim
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Subjects over 45 years of age
Subjects 45 years of age or younger
Find a Clinic Near You
Who Is Running the Clinical Trial?
Julie Fisher, MD
Lead Sponsor
Wake Forest University Health Sciences
Lead Sponsor
Atrium Health Levine Cancer Institute
Collaborator
Citations
A retrospective review of the real-world experience ...
In the whole cycle cohort, first cycle FN rates from those in the full cycle analysis were 2/83 (2.4%) and 3/59 (5.1%) for Neulasta® and Lapelga®, respectively ...
Economic and clinical outcomes of pegfilgrastim via ...
This is the first large real-world database analysis investigating the clinical and economic outcomes between PFS and OBI methods of pegfilgrastim ...
A randomized double-blind multicenter phase III study ...
A single 6 mg injection of pegfilgrastim was as effective as daily injections of filgrastim for all efficacy measures for all cycles.
Febrile Neutropenia Reduction | Neulasta® (pegfilgrastim ...
Next-day Neulasta reduced the incidence of FN by 94% when used every cycle, at the right time 3,† Neulasta ® 1% vs placebo 17%, P < 0.001.
On-body injector pegfilgrastim for chemotherapy-induced ...
Pegfilgrastim administered via an OBI device is reported to be as effective at preventing CIN/FN as when delivered via PFS or auto-injector methods [17,18]. The ...
SAFETY DATA SHEET
Skin Sensitization: Not determined, however, based on the characteristics of this substance may have the potential to be a skin sensitizer.
Neulasta®
Pegfilgrastim has been classified per Amgen's Hazard. Classification System as an Occupational Exposure Band 4 compound (5 µg/m3 - 20. µg/m3). Engineering ...
PEGFILGRASTIM-FPGK injection, for subcutaneous use
No overall differences in safety were identified between adult and pediatric patients based on postmarketing surveillance and review of the scientific ...
The Safety Profile of Filgrastim and Pegfilgrastim - PMC
Overall, filgrastim and pegfilgrastim have a high margin of safety for short-term use; however, rare severe adverse events have emerged.
10.
fresenius-kabi.com
fresenius-kabi.com/content/dam/fresenius-kabi/us/documents/resource-center/safety-and-compliance/Pegfilgrastim_06_mg06_mL_SDS_NA2015_072922_FINAL.pdfSTIMUFEND® (pegfilgrastim-fpgk) injection, for ...
Hazard Statements (GHS-US/CA). : H361 - Suspected of damaging fertility or the unborn child. Precautionary Statements (GHS-US/CA) : P201 - ...
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