Longitudinal ctDNA Surveillance for Older Women With ER+ Breast Cancer Who Omit Surgery

NCT05914792 | Active Not Recruiting

• 2 other identifiers: HCC 22-088STUDY21100091
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective study recruits patients with ER+/HER2-, non-metastatic breast cancer who omit upfront surgery in favor of primary endocrine therapy for sample collection and prospective circulating tumor DNA (ctDNA) measurement to guide disease surveillance.

Conditions

Breast Cancer

Keywords

estrogen receptor positive (ER+); progesterone receptor (PR+); early-stage breast cancer

Outcome Measures

Primary Outcomes (1)

• Proportion of ctDNA positivity

  Proportion of patients with ER+/HER2- breast cancer who omit upfront surgery in favor of primary endocrine therapy who have any ctDNA positivity using Signatera assay.

  Up to 5 years

Secondary Outcomes (4)

• Progression-free survival (PFS)

  Up to 5 years

• Breast cancer-specific survival (BCSS)

  Up to 5 years

• Overall survival (OS)

  Up to 5 years

• Longitudinal quality of life assessment using National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Breast Cancer Symptom Index - 16 Item Version (NCCN NFBSI-16)

  Up to 5 years

Eligibility Criteria

• Age: 70 Years+
• Gender Eligibility Details: Women only with ER+ breast cancer
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women 70 years of age or older with ER+/HER2-, non-metastatic breast cancer who forego upfront surgery in favor of primary endocrine therapy.

You may qualify if:

• early-stage (stages I-III) breast cancer
• estrogen receptor positive (ER+) and/or progesterone receptor positive (PR+) and HER2 receptor negative
• able to provide blood samples
• decision made by treating physician and patient to forego upfront surgery in favor of medical management with endocrine therapy
• non-metastatic disease at diagnosis (patients need not have staging scans; patients at higher risk for de novo stage IV disease should not have any symptoms concerning for metastatic disease)
• patients may be taking any endocrine therapy
• patients may be taking any CDK4/6 inhibitor as deemed necessary by their treating physician
• any ECOG Performance Status allowed
• if patients have synchronous bilateral ER+ breast cancer, tissue from both sites should be submitted to Natera to perform ctDNA testing
• patients with multifocal/multicentric tumors are eligible and the largest focus of cancer should be submitted for testing

You may not qualify if:

• under 70 years of age
• breast cancer that is not estrogen receptor positive (ER+) or progesterone receptor (PR+)
• unable to provide blood samples or insufficient tumor tissue for Signatera testing

Sponsors & Collaborators

• University of Pittsburgh: lead
• Natera, Inc.: collaborator

Study Sites (1)

UPMC Magee Womens Hospital - Surgical Oncology

Pittsburgh, Pennsylvania, 15232, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Patient blood to track ctDNA longitudinally over time as well as any tissue samples that the patient may have (including core biopsy samples and/or surgical specimens should the patient and their treating physician decide to undergo salvage surgery at any point).

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Priscilla McAuliffe, MD, PhD

  UPMC Magee Women's Hospital, UPMC Hillman Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: June 13, 2023
• First Posted: June 22, 2023
• Study Start: April 19, 2022
• Primary Completion: October 16, 2024
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)