The Hurria Older PatiEnts (HOPE) With Breast Cancer Study

NCT01472094 | Active Not Recruiting DMC

• 2 other identifiers: 111271R01AG037037-01
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 17

Brief Summary

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (4)

• Develop a predictive model of clinical and biological predictors for grade 2-5 toxicity to adjuvant and neoadjuvant 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.

  6 months after completion of chemotherapy

• Identify the specific chemotherapy toxicities associated with reduced relative dose intensity of the prescribed chemotherapy regimen.

  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.

  6 months after completion of chemotherapy

Secondary Outcomes (1)

• Assess potential biomarkers for physiologic age, including interleukin-6, C-reactive protein, D-dimer, and p16 expression.

  6 months after completion of chemotherapy

Study Arms (1)

Patients

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

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• 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)

You may qualify if:

• 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

You may not qualify if:

• Patients with metastatic disease
• Breast Cancer Controls:
• 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
• Patients with metastatic disease
• Receipt of chemotherapy
• Healthy Controls:
• 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

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (17)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

Yale University

New Haven, Connecticut, 06510, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Washington University St. Louis

St Louis, Missouri, 63110, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Hofstra-North-LIJ Cancer Institute

New Hyde Park, New York, 11042, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27514, United States

Location

Wake Forest University

Winston-Salem, North Carolina, 27106, United States

Location

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

University of Virginia Health System

Charlottesville, Virginia, 22903, United States

Location

Related Publications (4)

• Hurria A, Togawa K, Mohile SG, Owusu C, Klepin HD, Gross CP, Lichtman SM, Gajra A, Bhatia S, Katheria V, Klapper S, Hansen K, Ramani R, Lachs M, Wong FL, Tew WP. Predicting chemotherapy toxicity in older adults with cancer: a prospective multicenter study. J Clin Oncol. 2011 Sep 1;29(25):3457-65. doi: 10.1200/JCO.2011.34.7625. Epub 2011 Aug 1.

  PMID: 21810685 BACKGROUND

• Ji J, Bae M, Sun CL, Wildes TM, Freedman RA, Magnuson A, O'Connor T, Moy B, Klepin HD, Chapman AE, Tew WP, Dotan E, Fenton MA, Kim H, Katheria V, Gross CP, Cohen HJ, Muss HB, Sedrak MS. Falls prechemotherapy and toxicity-related hospitalization during adjuvant chemotherapy for breast cancer in older women: Results from the prospective multicenter HOPE trial. Cancer. 2024 Mar 15;130(6):936-946. doi: 10.1002/cncr.35105. Epub 2023 Nov 14.

  PMID: 37962093 DERIVED

• Sedrak MS, Sun CL, Ji J, Cohen HJ, Gross CP, Tew WP, Klepin HD, Wildes TM, Dotan E, Freedman RA, O'Connor T, Chow S, Fenton MA, Moy B, Chapman AE, Dale W, Katheria V, Kuderer NM, Lyman GH, Magnuson A, Muss HB. Low-Intensity Adjuvant Chemotherapy for Breast Cancer in Older Women: Results From the Prospective Multicenter HOPE Trial. J Clin Oncol. 2023 Jan 10;41(2):316-326. doi: 10.1200/JCO.22.01440. Epub 2022 Dec 1.

  PMID: 36455189 DERIVED

• Magnuson A, Sedrak MS, Gross CP, Tew WP, Klepin HD, Wildes TM, Muss HB, Dotan E, Freedman RA, O'Connor T, Dale W, Cohen HJ, Katheria V, Arsenyan A, Levi A, Kim H, Mohile S, Hurria A, Sun CL. Development and Validation of a Risk Tool for Predicting Severe Toxicity in Older Adults Receiving Chemotherapy for Early-Stage Breast Cancer. J Clin Oncol. 2021 Feb 20;39(6):608-618. doi: 10.1200/JCO.20.02063. Epub 2021 Jan 14.

  PMID: 33444080 DERIVED

Related Links

• Related Info

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Mina Sedrak, MD

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 31, 2011
• First Posted: November 16, 2011
• Study Start: September 9, 2011
• Primary Completion: December 2, 2018
• Study Completion (Estimated): September 18, 2026
• Last Updated: November 10, 2025

Record last verified: 2025-11

Locations

US (17)