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Alkylating Agent

Eflapegrastim for Neutropenia in Breast Cancer

Phase 1
Recruiting
Research Sponsored by Spectrum Pharmaceuticals, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
New diagnosis of histologically confirmed early-stage breast cancer (ESBC), defined as operable Stage I to Stage IIIA breast cancer
Candidate to receive adjuvant or neoadjuvant TC chemotherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up cycles 2-4 (cycle length=21 days) (up to approximately 63 days)
Awards & highlights

Study Summary

This trial looks at whether a different schedule for giving a drug to prevent low white blood cell count works better than the standard schedule.

Who is the study for?
This trial is for adults with early-stage breast cancer who are set to receive TC chemotherapy. They must have normal organ function, not be pregnant or breastfeeding, and agree to use two forms of contraception. People with other serious illnesses, recent investigational drug use, or prior treatments that could interfere are excluded.Check my eligibility
What is being tested?
The study tests Eflapegrastim's effect on severe neutropenia duration in patients receiving Docetaxel and Cyclophosphamide for breast cancer. It explores different timing intervals for administering Eflapegrastim after the chemotherapy drugs.See study design
What are the potential side effects?
Eflapegrastim may cause bone pain, muscle aches, fever-like symptoms, injection site reactions, and allergic responses due to its role in increasing white blood cell counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been newly diagnosed with early-stage breast cancer that can be operated on.
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I am eligible for additional chemotherapy before or after surgery.
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My kidneys are functioning well.
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I am at least 18 years old.
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I can perform all self-care but may not be able to work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~cycles 2-4 (cycle length=21 days) (up to approximately 63 days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and cycles 2-4 (cycle length=21 days) (up to approximately 63 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time to Recovery of Absolute Neutrophil Count (ANC) From Nadir to ≥1.5×10^9/L in Cycle 1
Secondary outcome measures
Duration of Grade 4 Neutropenia (DSN) in Cycle 1
Expansion Phase: DSN in Cycles 2-4
Expansion Phase: Incidence of FN in Cycles 2-4
+8 more
Other outcome measures
CD34+ count in the peripheral blood during Cycle 1

Trial Design

4Treatment groups
Experimental Treatment
Group I: Expansion Phase: Eflapegrastim @ 30 mins post TCExperimental Treatment3 Interventions
Eflapegrastim (13.2 mg/0.6 mL fixed dose, equivalent to 3.6 mg G-CSF). Supplied in prefilled single-use syringes for subcutaneous injection. Cycles 1-4: Administered on the same day as TC chemotherapy, 30 minutes following the end of TC administration. Each cycle is 21 days.
Group II: Early Phase: Eflapegrastim @ 5 hours post TCExperimental Treatment3 Interventions
Eflapegrastim (13.2 mg/0.6 mL fixed dose, equivalent to 3.6 mg G-CSF). Supplied in prefilled single-use syringes for subcutaneous injection. Cycle 1: Administered on the same day as TC chemotherapy, 5 hours from the end of TC administration. Cycles 2-4: Administered 24 hours after TC chemotherapy administration. Each cycle is 21 days.
Group III: Early Phase: Eflapegrastim @ 30mins post TCExperimental Treatment3 Interventions
Eflapegrastim (13.2 mg/0.6 mL fixed dose, equivalent to 3.6 mg granulocyte colony-stimulating factor [G-CSF]). Supplied in prefilled single-use syringes for subcutaneous injection. Cycle 1: Administered on the same day as TC chemotherapy, 30 minutes from the end of TC administration. Cycles 2-4: Administered 24 hours after TC chemotherapy administration. Each cycle is 21 days.
Group IV: Early Phase: Eflapegrastim @ 3 hours post TCExperimental Treatment3 Interventions
Eflapegrastim (13.2 mg/0.6 mL fixed dose, equivalent to 3.6 mg G-CSF). Supplied in prefilled single-use syringes for subcutaneous injection. Cycle 1: Administered on the same day as TC chemotherapy, 3 hours from the end of TC administration. Cycles 2-4: Administered 24 hours after TC chemotherapy administration. Each cycle is 21 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
FDA approved
Docetaxel
FDA approved

Find a Location

Who is running the clinical trial?

Spectrum Pharmaceuticals, IncLead Sponsor
82 Previous Clinical Trials
8,139 Total Patients Enrolled
8 Trials studying Breast Cancer
1,118 Patients Enrolled for Breast Cancer
Shanta Chawla, MDStudy DirectorSpectrum Pharmaceuticals, Inc
8 Previous Clinical Trials
2,144 Total Patients Enrolled
3 Trials studying Breast Cancer
330 Patients Enrolled for Breast Cancer

Media Library

Breast Cancer Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT04187898 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who meets the qualifications to join this clinical experiment?

"To qualify for this trial, participants must have neutropenia and be between 18 to 55 years of age. In total, 90 individuals are required for the study."

Answered by AI

How secure is the use of Eflapegrastim for individuals?

"Our research team at Power has determined the safety of Eflapegrastim to be a 1 due to its status as an experimental drug in Phase 1 trials; there is only limited evidence for both efficacy and safety."

Answered by AI

In which instances is Eflapegrastim most commonly employed?

"Eflapegrastim is predominately used to treat neoplasm metastasis, but it can also be helpful for more advanced cases of bladder cancer, end-of-life directives, and certain types of lung cancers."

Answered by AI

Is this experiment seeking participants aged 20 or older?

"This research requires patients aged between 18 and 55. For those under 18, there are 387 studies available while 3427 have been designed for seniors over 65 years old."

Answered by AI

Is this research endeavor appearing in multiple locations across Canada?

"Patients are currently being accepted at City of Hope in Long Beach, California, Pacific Shores Oncology in Winter Haven, Florida, and Bond & Steele Clinic, P.A. in Yuma, Arizona among other clinical trial sites across the country."

Answered by AI

Are there any reports of prior research surrounding Eflapegrastim?

"Eflapegrastim was initially investigated at City of Hope Comprehensive Cancer Center in 1997. Since then, the compound has been tested through 1,833 clinical trials with an additional 1,104 presently active studies largely based out of Long Beach, California."

Answered by AI

How many volunteers are engaged in this experiment?

"Spectrum Pharmaceuticals, Inc. is sponsoring this clinical trial and require 90 eligible patients to complete it. The trial will be conducted at City of Hope in Long Beach, California as well as Pacific Shores Oncology in Winter Haven, Florida."

Answered by AI

Are individuals currently being accepted into the experiment?

"Correct. According to the details on clinicaltrials.gov, this medical experiment, which was first unveiled in March 11th 2020, is still recruiting participants. 90 volunteers need to be recruited from 9 distinct facilities."

Answered by AI

Who else is applying?

What state do they live in?
Florida
What site did they apply to?
Bond & Steele Clinic, P.A.
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Open-Label, Phase 1 Study to Evaluate Duration of Severe Neutropenia After Same-Day Dosing of Eflapegrastim in Patients With Breast-Cancer
2020. "Open-Label, Phase 1 Study to Evaluate Duration of Severe Neutropenia After Same-Day Dosing of Eflapegrastim in Patients With Breast-Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04187898.
All > Breast Cancer Anaheim
~3 spots leftby Jul 2024
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