NCT04174742Active, not recruiting
Self Reported Pain in Women While Undergoing Treatment for Non-metastatic Breast Cancer
Self-Reported Pain and Nadir White Blood Cell/Absolute Neutrophil Count in Women 45 and Under Compared to Older Women Receiving Pegfilgrastim (or Biosimilar Substitution) While Undergoing Chemotherapy for Non-Metastatic Breast Cancer
Source: ClinicalTrials.gov · Last updated 13 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 115 (estimated)
- First submitted
- 31 Oct 2019
- Start date
- 17 Dec 2019
- Primary completion date
- Jan 2041
- Lead sponsor
- Wake Forest University Health Sciences
- Diseases
- Metastatic breast cancer
- NCT number
- NCT04174742
What you commit to
- Study type: Observational
- Planned participants: 115
- From 17 Dec 2019 to the primary completion date, Jan 2041
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Have previously received chemotherapy or radiation other than the first cycle of the planned adjuvant or neoadjuvant chemotherapy as indicated in Inclusion #5
Other illness
- Uncontrolled intercurrent illness/medical condition or psychiatric illness/social situations that would limit compliance with study requirements as determined by the investigator
- Diagnosis of distant metastatic breast cancer
- Diagnosis of a chronic pain syndrome (e.g. fibromyalgia, severe osteoarthritis, etc.)
Other
- Subjects meeting any of the criteria below may not participate in the study:
- Taking chronic narcotics, as determined by treating physician
- A baseline ESAS pain score of greater than 8.
Who the study is looking for
- Subject must meet all the following applicable inclusion criteria to participate in this study:
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Levine Cancer Institute Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| Wake Forest Baptist Comprehensive Cancer Center Coordinator of this site? Confirm its status | Winston-Salem | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.