Breast CancerNCT01472094
The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
An observational study of Breast Cancer, run by City of Hope Medical Center at 17 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- How many people
- 700 participants
- Where
- 17 sitesUnited States
- Study dates
- 9 Sep 2011to 8 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
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)
Who may be able to join
- 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
- Patients with stages I-III breast cancer
- Patient will not receive adjuvant or neoadjuvant chemotherapy
Show all 13Show fewer
- Patients age ≥65 and of any performance status are eligible
- Able to understand English
- Able to provide informed consent
- 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
Who cannot join
- Patients with metastatic disease
- Breast Cancer Controls:
- Patients with metastatic disease
- Receipt of chemotherapy
- Healthy Controls:
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Roswell Park Cancer Institute
Buffalo, New York, 14263
University of North Carolina
Chapel Hill, North Carolina, 27514
University of Virginia Health System
Charlottesville, Virginia, 22903
University of Chicago
Chicago, Illinois, 60637
Case Western Reserve University
Cleveland, Ohio, 44106
City of Hope Medical Center
Duarte, California, 91010
Yale University
New Haven, Connecticut, 06510
Hofstra-North-LIJ Cancer Institute
New Hyde Park, New York, 11042
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Rhode Island Hospital
Providence, Rhode Island, 02903
University of Rochester Medical Center
Rochester, New York, 14642
Washington University St. Louis
St Louis, Missouri, 63110
Wake Forest University
Winston-Salem, North Carolina, 27106
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients | All patients 65 years old with Stage I to III breast cancer who are beginning adjuvant or neo-adjuvant chemotherapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Develop a predictive model of clinical and biological predictors for grade 2-5 toxicity to adjuvant and neoadjuvant chemotherapy.
Measured: 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.
Measured: 6 months after completion of chemotherapy
Identify the specific chemotherapy toxicities associated with reduced relative dose intensity of the prescribed chemotherapy regimen.
Measured: 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.
Measured: 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.
Measured: 6 months after completion of chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2011 (estimated)
- Study start9 Sep 2011
- Primary completion2 Dec 2018
- Study completion8 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Mina Sedrak, MD, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01472094
- Sponsor's protocol ID
- 11127
- Other IDs
- 1R01AG037037-01
- Status last verified
- Oct 2026
- First submitted
- 31 Oct 2011
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21810685Ji 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.
PubMed 37962093Sedrak 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.
PubMed 36455189Magnuson 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.
PubMed 33444080
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Biological Predictors of Chemotherapy Toxicity in Older Adults
- ClinicalTrials.gov ID
- NCT01472094
- Acronym / sponsor ID
- 11127
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA)
- Study start
- 9 Sep 2011 (actual)
- Primary completion
- 2 Dec 2018 (actual)
- Study completion
- 8 Sep 2027 (estimated)
- First posted
- 16 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | –All patients 65 years old with Stage I to III breast cancer who are beginning adjuvant or neo-adjuvant chemotherapy. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- 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)
Key inclusion criteria (13 listed)
- 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
- Patients with stages I-III breast cancer
Key exclusion criteria (5 listed)
- Patients with metastatic disease
- Patients with metastatic disease
- Receipt of chemotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
Identify the specific chemotherapy toxicities associated with reduced relative dose intensity of the prescribed chemotherapy regimen.
Time frame: 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
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Background: PubMed 21810685Hurria 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.
- Derived from this study: PubMed 37962093Ji 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.
- Derived from this study: PubMed 36455189Sedrak 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.
- Derived from this study: PubMed 33444080Magnuson 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mina Sedrak, MD principal investigator
City of Hope Medical Center
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by City of Hope Medical Center at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01472094, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.