Improving Outcomes for Older Patients with Breast Cancer, Elevate Study

Status: closed to accrual

This study investigates the experiences, treatments, and outcomes of older patients with breast cancer. Information gathered from this study may help researchers better understand the experiences, barriers, and changes in physical function older patients with breast cancer may have, and why they decide to have a certain treatment or not, and whether they continue their treatment for as long as the doctor recommends. This may ultimately help researchers understand how they can improve upon breast cancer and health outcomes for older patients with breast cancer, a group of patients who often have low risk cancers, but who may do worse than younger participants with the same kind of cancers.

Inclusion Criteria

Age 70 or older at the time of diagnosis (as indicated by the date of breast biopsy) * No more than approximately 83 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 (ductal carcinoma in situ [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: Dana-Farber Cancer Institute (DFCI)/satellite, partner, 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 patient reported outcomes [PROs] are readily available in multiple languages)
If a patient scores 11 or higher on the baseline Orientation-Memory-Concentration Test done at baseline, 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 or Spanish AND no designee who speaks and reads English or Spanish, as above
Unable to provide informed consent

PRIMARY OBJECTIVE:

I. Examine adjuvant treatment recommendations, treatment receipt and adherence, and individualized treatment/adherence barriers among enrolled patients and compare treatment patterns by patient age and other relevant characteristics.

SECONDARY/EXPLORATORY OBJECTIVES:

I. Examine invasive disease-free survival, local recurrences, distant recurrences, overall survival, causes of death, and breast cancer-specific survival for all enrolled patients.

II. Examine tumor genomics and cell-free deoxyribonucleic acid (DNA) among patients who do and do not experience relapse.

III. Explore the tumor microenvironment, including immunological biomarkers, in archived and fresh tissue samples and compare findings with those in younger women.

IV. Examine blood for clonal hematopoiesis of indeterminate potential (CHIP) and associations of CHIP results with survival, breast cancer recurrences, and toxicity event.

V. Examine provider satisfaction with receiving the summarized Geriatric Assessment results for their patient.

OUTLINE:

Patients complete questionnaires over 15-30 minutes at baseline, 6, 12, 18, and 24 months and at 3, 4, and 5 years. Patients also undergo collection of blood samples at baseline, 12 months, and 3 years. Patients' previously collected tissue sample is requested and patients may also undergo collection of tissue sample at time of surgery. Patients' medical records are reviewed periodically for up to 10 years.

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Improving Outcomes for Older Patients with Breast Cancer, Elevate Study

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