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Active, Not Recruiting

NCT Number: NCT03818087

Elevate! : An Elderly Breast Cancer Cohort Study

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

70 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Northern Light Cancer Care, Bangor, Maine, United States

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About this study

This study is focused on understanding how the investigators can improve upon breast cancer and health outcomes for older participants with breast cancer, a group of participants who often have low risk cancers, but who may do worse than younger participants with the same kind of cancers. Researchers want to better understand the experiences, barriers, and changes in physical function older participants with breast cancer have.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Observational Cohort

Behavioral

Patients will be followed by collecting clinical data, biospecimens, and quality of life assessments over a period of five years from registration.

Primary outcomes

  1. Adjuvant treatment recommendations

    Time frame: 7 years

    Report treatment recommendations made to patients enrolled on the cohort

  2. Adherence to hormonal therapy

    Time frame: 7 years

    We will survey patients on adherence

  3. Barriers to treatment and adherence

    Time frame: 7 years

    We will survey patients on the reasons for adherence and poor adherence

  4. Treatment patterns by age and other characteristics

    Time frame: 7 years

    We will examine treatment receipt and patterns by subtype of disease

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Collaborators

  • Susan G. Komen Breast Cancer Foundation

Registry information

Official study title

Elevate! : Improving Outcomes for Older Patients With Breast Cancer:a Longitudinal Cohort and Patient Engagement Study

Important dates

Study start
2019
Primary completion
2027
Study completion
2028
First posted
Jan 28, 2019
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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