Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
253 participants
OBSERVATIONAL
2019-02-19
2028-11-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Elevate
Participants over the age of 70 years old with early-stage breast cancer will be recruited.
Observational cohort
Patients will be followed by collecting clinical data, biospecimens, and quality of life assessments over a period of five years from registration.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Observational cohort
Patients will be followed by collecting clinical data, biospecimens, and quality of life assessments over a period of five years from registration.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
70 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Susan G. Komen Breast Cancer Foundation
OTHER
Dana-Farber Cancer Institute
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Rachel Freedman, MD, MPH
Primary Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Rachel A Freedman, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
18-634
Identifier Type: -
Identifier Source: org_study_id