Elevate! : An Elderly Breast Cancer Cohort Study

Running, not enrolling

Conditions studied: Breast Cancer

In brief

This study is focused on understanding how the investigators can improve upon breast cancer and health outcomes for older participants with breast cancer.

Key facts

Study ID

NCT03818087

Run by

Dana-Farber Cancer Institute

People needed

253

Starts

2019-02-19

Expected to finish

2028-11-01

Last updated by the study team

2025-12-19

Who can join

Age: 70 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Age 70 or older at the time of diagnosis (as indicated by the date of breast biopsy)
• No more than 67 patients (1/3) will be aged 70-74, with the remaining patients on study ages 75 or older
• Any gender is eligible
• Invasive, non-metastatic breast cancer at diagnosis
• Those with prior diagnoses of pre-invasive (DCIS) or invasive breast cancer are eligible as long as their current diagnosis is felt by the treating provider to represent a NEW non-metastatic primary invasive breast cancer (e.g. someone with a nodal recurrence from prior disease are not eligible but those with a new contralateral breast cancer 3 years after a first breast cancer would be eligible)
• Any breast cancer subtype is allowed
• Breast cancer-diagnosing biopsy within 90 days of enrollment
• Receiving or will receive medical oncology care (+/- surgical and radiation oncology treatments) at the participating center: DFCI/satellites and affiliate sites
• Patients must be able to understand, speak, and read English or assign a designated caregiver/proxy for the duration of the study who understands, speaks, and reads English and who is willing to assist with filling out the survey components which do not have a validated, translated version. This is because the surveys are not readily available in multiple languages as a whole, although some components (such as the Geriatric Assessment and PROs are readily available in multiple languages).
• If a patient scores 11 or higher on the baseline Orientation-Memory-Concentration Test done at baseline (Appendix E), a proxy/designee must then be assigned to help the patient fill out the questionnaires for the duration of the study in order to participate. The treating provider will also be notified about the cognitive impairment.
• Ability to provide informed consent

You may not qualify if…

• Pathological or clinical stage 0, IV disease
• Those with nodal or metastatic recurrences at the time of enrollment
• Unable to speak and read English AND no designee who speaks and reads English, as above
• Unable to provide informed consent

Where it is running

• Northern Light Cancer Care — Bangor, Maine, United States
• Brigham and Women Hospital — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Lifespan Cancer Institute — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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