Recruiting

Observational Study

Sponsor:

UNC Lineberger Comprehensive Cancer Center

Code:

NCT06789653

Conditions

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 22 - 66

Healthy Volunteers: Not accepted

Interventions

p16INK4a mRNA level assessment

organ-specific protein signatures assessment

Study Details

Brief summary:

This study compares changes in P16INK4A expression and plasma proteomic signatures of specific organ age pre- and post-chemotherapy in women treated with adjuvant chemotherapy for early-stage breast cancer. It aims to determine if biological and accelerated immune aging, assessed using T cells from peripheral blood, represents aging in different organs.

Patients receiving chemotherapy, especially adjuvant regimens that include anthracyclines and taxanes, often experience late development of cardiac toxicity, functional loss, and cognitive decline. Comparing baseline characteristics with organ aging before therapy might identify patients at the highest risk for chemotherapy complications. For example, this is clinically significant for patients whose therapy includes taxanes or other drugs known to cause peripheral neuropathy. Identifying aging in the neurological or vascular systems before treatment might lead to changes in regimens.

Determining accelerated aging in specific organs allows for investigating interventions to mitigate organ damage. For instance, identifying patients at the highest risk of cardiac aging after treatment could lead to testing the effects of exercise, senolytics, and other strategies to reduce the risk of long-term heart disease.

Conditions

Breast Cancer

Study ID

NCT06789653

Start date

Oct 10, 2024

Status verified date

Aug, 2026

Completion date

Nov 1, 2027

Anticipated

Primary completion date

Nov 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 22 - 66

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age ≥22years and <66 years
  • Diagnosed with early-stage breast cancer (The American Joint Committee on Cancer stages I-III).
  • Understand and read English.
  • Receive care at the study site.
  • Able to understand and participate in study procedures for length of study.

Exclusion Criteria:

  • Unable to provide consent, unable to communicate verbally.
  • Unable to understand or read English.
  • Enrolled in hospice care.

Study Design

Enrollment

80 participants

Anticipated

Interventions and Outcome Measures

Arms

Chemotherapy

40 patients with early-stage breast cancer whose treatment plan includes adjuvant or neoadjuvant chemotherapy.

Control

20 patients with early-stage breast cancer whose treatment plan does not includeadjuvant or neoadjuvant chemotherapy.

Interventions

p16INK4a mRNA level assessment

Blood samples will be collected at two time points, plasma samples will be aliquoted, and T cells will be separated and expression of p16INK4a mRNA in peripheral blood T-lymphocytes will be determined

organ-specific protein signatures assessment

Blood samples will be collected at two time points, plasma samples will be aliquoted, and organ-specific protein signatures assessment will be determined.

Primary outcome measure

  • p16INK4a level changes over time [ Time Frame: Up to 8 months ]
  • Organ-specific protein expression change over time [ Time Frame: Up to 8 months ]

Central Contacts and Locations

Central contacts

Locations

University of North Carolina

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Principal Investigator:

Hyman Muss, MD

More Information

Sponsor

UNC Lineberger Comprehensive Cancer Center

Last update posted

Aug 18, 2026

Last verified

Aug, 2026

Keywords

  • proteomic
  • plasma proteomic
  • P16INK4A
  • chemotherapy
  • T cells
  • aging
  • morbidity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by UNC Lineberger Comprehensive Cancer Center on 2026-08-18.