Elevate! : An Elderly Breast Cancer Cohort Study

NCT03818087 | Active Not Recruiting

• 1 other identifier: 18-634
• Study Type: observational
• Target: 253
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Breast Cancer

Keywords

Breast Cancer

Outcome Measures

Primary Outcomes (4)

• Adjuvant treatment recommendations

  Report treatment recommendations made to patients enrolled on the cohort

  7 years

• Adherence to hormonal therapy

  We will survey patients on adherence

  7 years

• Barriers to treatment and adherence

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

  7 years

• Treatment patterns by age and other characteristics

  We will examine treatment receipt and patterns by subtype of disease

  7 years

Study Arms (1)

Elevate

Participants over the age of 70 years old with early-stage breast cancer will be recruited.

Behavioral: Observational cohort

Interventions

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.

Elevate

Eligibility Criteria

• Age: 70 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Age 70 or older at the time of diagnosis

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

Sponsors & Collaborators

• Susan G. Komen Breast Cancer Foundation: collaborator
• Dana-Farber Cancer Institute: lead

Study Sites (4)

Northern Light Cancer Care

Bangor, Maine, 04401, United States

Location

Brigham and Women Hospital

Boston, Massachusetts, 02215, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Lifespan Cancer Institute

Providence, Rhode Island, 02903, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Archival tissue will be collected from participant's prior surgeries and procedures. Some participants undergoing breast surgery during the five years of participation may have a sample of fresh tissue taken for research purposes in the operating room. Blood will be collected at registration and at serial timepoints over a period of five years.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Rachel A Freedman, MD, MPH

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: December 19, 2018
• First Posted: January 28, 2019
• Study Start: February 19, 2019
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): November 1, 2028
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data can be shared no earlier than 1 year following the date of publication.
• Access Criteria: Requests may be directed to: \[contact information for Sponsor- Investigator or designee\].

Locations

US (4)