To hear about similar clinical trials, please enter your email below
Trial Title:
Longitudinal ctDNA Surveillance for Older Women With ER+ Breast Cancer Who Omit Surgery
NCT ID:
NCT05914792
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
estrogen receptor positive (ER+)
progesterone receptor (PR+)
early-stage breast cancer
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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.
Detailed description:
Age is one of the most important risk factors for the development of breast cancer.
Nearly a third of all breast cancer cases occur in older women (aged ≥ 70 years), with
most cases being estrogen receptor-positive (ER+). Such tumours are unlikely to be the
ultimate cause of death for older women, particularly when considering other
comorbidities. Our group has recently shown that risk of breast cancer-related mortality
is only around 3% for older women who forego upfront surgery and instead treated with
primary endocrine monotherapy. However, with omission of surgery, surveillance for tumor
growth or treatment failure is important but requires patients (and their caregivers) to
have regular imaging and to see their oncology team every 3 months, which can be quite
burdensome. Thus, this study employs a ctDNA surveillance scheme to monitor for potential
tumor growth. Partnering with Natera, this study uses a bespoke, tumor-specific ctDNA
assay (Signatera) to monitor for changes in ctDNA dynamics while the patient is on
endocrine therapy.
This study is for patients who choose not to undergo primary surgical intervention and
are managed medically on primary endocrine therapy (any endocrine therapy permitted).
Patients will undergo Signatera testing at the time of regularly scheduled clinic
follow-up visits and/or at the time of surveillance imaging, which will occur every 3-6
months. Patients will also be asked to complete regular surveys while participating in
the study.
Criteria for eligibility:
Study pop:
Women 70 years of age or older with ER+/HER2-, non-metastatic breast cancer who forego
upfront surgery in favor of primary endocrine therapy.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Gender:
Female
Gender based:
Yes
Gender description:
Women only with ER+ breast cancer
Minimum age:
70 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
UPMC Magee Womens Hospital - Surgical Oncology
Address:
City:
Pittsburgh
Zip:
15232
Country:
United States
Status:
Recruiting
Contact:
Last name:
Neil Carleton
Phone:
412-641-8554
Email:
carletonn2@upmc.edu
Investigator:
Last name:
Priscilla McAuliffe, MD, PhD
Email:
Principal Investigator
Start date:
April 19, 2022
Completion date:
June 30, 2030
Lead sponsor:
Agency:
University of Pittsburgh
Agency class:
Other
Source:
University of Pittsburgh
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05914792
