Improving Outcomes for Older Patients with Breast Cancer, Elevate Study

Active:	No
Cancer Type:	Breast Cancer	NCT ID:	NCT03818087
Trial Phases:		Protocol IDs:	18-634 (primary) NCI-2020-08912
Eligibility:	70 Years and older, Male and Female	Study Type:	Other
Study Sponsor:	Dana-Farber Harvard Cancer Center
NCI Full Details:	http://clinicaltrials.gov/show/NCT03818087

Summary

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.

Objectives

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.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.