Self Reported Pain in Women While Undergoing Treatment for Non-metastatic Breast Cancer

NCT04174742 | Recruiting FDA Drug

• 3 other identifiers: IRB00081356Pro00037721LCI-BRE-GCSF-001
• Study Type: observational
• Target: 115
• Locations: 1 country
• Sites: 2

Brief Summary

The overall purpose of this study is to investigate whether younger subjects report pain with pegfilgrastim (or biosimilar substitution) more often and/or at higher levels (greater intensity) than older subjects.This study will be carried out throughout the course of your chemotherapy treatment, which will be prescribed by your study doctor. Participation in this study will not affect your cancer treatment.

Conditions

Breast; Breast Cancer

Keywords

Pain

Outcome Measures

Primary Outcomes (1)

• Frequency of pain

  investigate whether younger patients report pegfilgrastim (or biosimilar substitution)-induced pain with greater frequency than older patients.

  approx 7 months

Secondary Outcomes (2)

• Intensity of pain

  approx 7 months

• White Blood Cell/Absolute Neutrophil Count (WBC/ANC)

  On day 7 of each pegfilgrastim or biosimilar substitution cycle (28 day cycle, approx 4-6 cycles) through study completion (one week after last administration of pegfilgrastim or biosimilar substitution)

Study Arms (2)

A

Subjects 45 years of age or younger

Drug: pegfilgrastim

B

Subjects over 45 years of age

Drug: pegfilgrastim

Interventions

pegfilgrastim DRUG

It works by increasing neutrophil migration to counteract cytotoxicity. It is commonly administered to patients receiving chemotherapy for breast cancer treatment. It has been shown to significantly reduce the incidence of neutropenic fever, although without statistically significant impact on overall survival.

A; B

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Female patients undergoing neoadjuvant or adjuvant chemotherapy for breast cancer who will receive pegfilgrastim (or biosimilar substitution) during their treatment.

You may qualify if:

• Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
• Age ≥ 18 years at the time of consent
• Female
• Histological or cytological confirmation of invasive breast cancer.
• Planned to undergo adjuvant or neoadjuvant chemotherapy treatment for invasive breast cancer AND pegfilgrastim (or biosimilar substitution) treatment for neutropenic prophylaxis.
• Ability to read and understand the English and/or Spanish language
• As determined by the enrolling physician, ability of the subject to understand and comply with study procedures for the entire length of the study

You may not qualify if:

• Subjects meeting any of the criteria below may not participate in the study:
• Uncontrolled intercurrent illness/medical condition or psychiatric illness/social situations that would limit compliance with study requirements as determined by the investigator
• Taking chronic narcotics, as determined by treating physician
• Diagnosis of distant metastatic breast cancer
• Diagnosis of a chronic pain syndrome (e.g. fibromyalgia, severe osteoarthritis, etc.)
• A baseline ESAS pain score of greater than 8.

Sponsors & Collaborators

• Atrium Health Levine Cancer Institute: collaborator
• Wake Forest University Health Sciences: lead

Study Sites (2)

Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

RECRUITING

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Pain

Interventions

pegfilgrastim

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Julie Fisher, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Moore, RN

CONTACT

980-442-2340; laura.moore1@atriumhealth.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2019
• First Posted: November 22, 2019
• Study Start: December 17, 2019
• Primary Completion (Estimated): January 1, 2041
• Study Completion (Estimated): January 1, 2041
• Last Updated: April 17, 2026

Record last verified: 2026-04

Locations

US (2)