The Hurria Older PatiEnts (HOPE) With Breast Cancer Study

April 4, 2024 updated by: City of Hope Medical Center

Clinical and Biological Predictors of Chemotherapy Toxicity in Older Adults

The goal of this study is to develop a "bedside to bench" model of clinical and biological predictors for toxicity to adjuvant and neoadjuvant chemotherapy in older adults with breast cancer. The investigators will develop a predictive model using clinical and biological predictors of toxicity to adjuvant and neoadjuvant chemotherapy in older adults with breast cancer. The investigators will also determine the association between clinical and biological factors and reduced relative dose intensity of the prescribed chemotherapy regimen. In addition, the investigators will explore specific chemotherapy toxicities associated with reduced relative dose intensity of a prescribed regimen.

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

Although cancer is a disease associated with aging, there is no standard tool in oncology practice that incorporates clinical and biological factors to identify older adults with cancer who may be more vulnerable to the toxicity of chemotherapy. It is generally recognized that chronological age tells relatively little about an older adult's physiological age. Oncologists allude to this when they describe an older adult as: "a 'young' 80-year-old" or "an 'old' 80-year-old," implying factors other than age contribute to the health status of an older adult. Geriatricians address this by routinely performing a "geriatric assessment," which measures independent clinical predictors of morbidity and mortality in older adults. In addition, several potential biomarkers of aging have been described that are associated with functional decline and mortality among older adults. This study will identify whether novel biomarkers of aging can predict risk of chemotherapy toxicity. The current proposal will fill this knowledge gap by melding the principles of geriatrics with those of oncology to create a tool to assess the clinical and biological risk factors for chemotherapy toxicity in older adults.

Furthermore, this study will determine the association between chemotherapy toxicity and dose reductions and/or delays that decrease chemotherapy dose intensity. Maintenance of chemotherapy dose intensity is necessary to maintain chemotherapy efficacy. Older adults are at risk for chemotherapy toxicity and if this toxicity results in decreased dose intensity, the benefits of chemotherapy will be compromised. This study will identify the association between clinical and biological predictors of grade 2-5 toxicity and relative dose intensity. Furthermore, this study will identify the specific dose-limiting toxicities. These data will provide evidence-based criteria to identify those patients whose projected risk of toxicity would limit dose intensity and compromise the efficacy of standard treatment. These data could serve as the basis for "vulnerable elderly trials" which would study an alternate therapy regimen in patients who are predicted to have a significant risk of toxicity (and compromised efficacy) with the standard regimen.

This proposal unites the fields of geriatrics and oncology, incorporating geriatric correlates of vulnerability and studying their impact in an aging oncology population. These data will be used to develop a predictive equation for the risk of chemotherapy toxicity that can be utilized in daily oncology practice. These data will facilitate decision-making regarding the risks and benefits of adjuvant chemotherapy in older adults with breast cancer and ultimately serve as a foundation on which to identify older adults at risk for chemotherapy toxicity in order to guide interventions to decrease this risk.

Study Type

Observational

Enrollment (Estimated)

700

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91010
        • City of Hope Medical Center
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale University
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana-Farber Cancer Institute
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University St. Louis
    • New York
      • Buffalo, New York, United States, 14263
        • Roswell Park Cancer Institute
      • New Hyde Park, New York, United States, 11042
        • Hofstra-North-LIJ Cancer Institute
      • New York, New York, United States, 10065
        • Memorial Sloan-Kettering Cancer Center
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • University of North Carolina
      • Winston-Salem, North Carolina, United States, 27106
        • Wake Forest University
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Case Western Reserve University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • University of Virginia Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Outpatient clinic practices (City of Hope, Memorial Sloan-Kettering Cancer Center, Yale University School of Medicine, University of Rochester, University of North Carolina, Wake Forest University, and Case Western Reserve University)

Description

Patients with Breast Cancer:

Inclusion Criteria:

  • Patients with stages I-III breast cancer receiving adjuvant or neoadjuvant chemotherapy
  • Able to understand English
  • Able to provide informed consent
  • Patients age ≥65 and of any performance status are eligible

Exclusion Criteria:

  • Patients with metastatic disease

Breast Cancer Controls:

Inclusion Criteria:

  • Patients with stages I-III breast cancer
  • Patient will not receive adjuvant or neoadjuvant chemotherapy
  • Patients age ≥65 and of any performance status are eligible
  • Able to understand English
  • Able to provide informed consent

Exclusion Criteria:

  • Patients with metastatic disease
  • Receipt of chemotherapy

Healthy Controls:

Inclusion Criteria:

  • Patients age ≥65 and of any performance status are eligible
  • No history of cancer (excluding non-melanoma skin cancer)
  • Able to understand English
  • Able to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients
All patients 65 years old with Stage I to III breast cancer who are beginning adjuvant or neo-adjuvant chemotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Develop a predictive model of clinical and biological predictors for grade 2-5 toxicity to adjuvant and neoadjuvant chemotherapy.
Time Frame: 6 months after completion of chemotherapy
6 months after completion of chemotherapy
Understand the association between clinical and biological factors and reduced relative dose intensity (RDI) of the prescribed chemotherapy regimen.
Time Frame: 6 months after completion of chemotherapy
6 months after completion of chemotherapy
Identify the specific chemotherapy toxicities associated with reduced relative dose intensity of the prescribed chemotherapy regimen.
Time Frame: 6 months after completion of chemotherapy
6 months after completion of chemotherapy
Understand the association between the receipt of adjuvant chemotherapy and change in functional status from pre-chemotherapy to end of chemotherapy.
Time Frame: 6 months after completion of chemotherapy
6 months after completion of chemotherapy

Secondary Outcome Measures

Outcome Measure
Time Frame
Assess potential biomarkers for physiologic age, including interleukin-6, C-reactive protein, D-dimer, and p16 expression.
Time Frame: 6 months after completion of chemotherapy
6 months after completion of chemotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

City of Hope Medical Center

Collaborators

National Institutes of Health (NIH)
National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Mina Sedrak, MD, City of Hope Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 9, 2011

Primary Completion (Actual)

December 2, 2018

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

October 31, 2011

First Submitted That Met QC Criteria

November 15, 2011

First Posted (Estimated)

November 16, 2011

Study Record Updates

Last Update Posted (Actual)

April 8, 2024

Last Update Submitted That Met QC Criteria

April 4, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11127 (DAIDS ES Registry Number)
  • 1R01AG037037-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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