MinorStudy completion pushed from Sep 18, 2026 to Sep 8, 2027
Eligibility criteria expanded, about 16 words
Publications: details revised at 4 of 4 entries
MinorStudy completion date: Oct 9, 2025 to Sep 18, 2026v26
MinorStudy completion date: Dec 30, 2024 to Oct 9, 2025v25
MinorStudy completion date: Dec 30, 2023 to Dec 30, 2024v24
MinorStudy completion date: Apr 30, 2023 to Dec 30, 2023v23
Show 21 earlier versionsHide 21 earlier versions
MinorStudy title shortened, about 1 wordv22
MinorPrimary completion date changed from estimate of Apr 30, 2022 to Dec 2, 2018
Study completion date: Apr 30, 2022 to Apr 30, 2023
v21
MinorPrimary and study completion dates: Apr 2022 to Apr 30, 2022v20
NotablePrimary and study completion dates: Apr 2020 to Apr 2022v19
MinorRe-verified, no change to tracked fieldsv18
NotablePrimary and study completion dates: Apr 2019 to Apr 2020v17
NotablePrimary and study completion dates: Apr 2018 to Apr 2019
Trial status: Recruiting to Active, Not Recruiting
Site details revised at 17 of 17 sites
v16
NotablePrimary completion date: Apr 2017 to Apr 2018
Study completion date: Apr 2018
Start date: Sep 2011 to Sep 9, 2011
v15
NotablePrimary completion date: Sep 2016 to Apr 2017v14
MinorStudy sites: 15 to 17v13
Minor2 versionsRe-verified since Feb 26, 2015, no change to tracked fieldsv11-v12
MinorStudy sites: 10 to 15v10
MinorStudy sites: 9 to 10v9
Minor2 versionsRe-verified since Nov 13, 2013, no change to tracked fieldsv7-v8
MinorStudy sites: 8 to 9v6
NotablePrimary endpoints: 3 to 4
Eligibility criteria expanded, about 82 words
v5
MinorEnrollment target: 500 to 700v4
MinorRe-verified, no change to tracked fieldsv3
MinorStudy sites: 7 to 8v2
MinorStudy First Submitted
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number
NCT01472094
Lead Sponsor
City of Hope Medical Center Collaborators: National Institutes of Health (NIH), National Institute on Aging (NIA)