Breast CancerNCT05914792
Longitudinal ctDNA Surveillance for Older Women With ER+ Breast Cancer Who Omit Surgery
An observational study of Breast Cancer, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and older, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Apr 2022to 1 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- Women only
- No healthy volunteers
- Older adult
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.
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Magee Womens Hospital - Surgical Oncology
Pittsburgh, Pennsylvania, 15232
About this study
Official title: Longitudinal ctDNA Monitoring in Older Women With ER+ Breast Cancer Who Forego Upfront Surgery in Favor of Primary Endocrine Therapy
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.
Read the 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.
- Conditions
- Breast Cancer
- Keywords
- estrogen receptor positive (ER+), progesterone receptor (PR+), early-stage breast cancer
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 5 years
Secondary outcomes (4)
Progression-free survival (PFS)
The length of time after treatment initiation that patient is alive and without any evidence of tumor progression as defined by RECIST1.1 criteria. Per RECISIT v1.1: Progressive Disease (PD): ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression.
Measured: Up to 5 years
Breast cancer-specific survival (BCSS)
BCSS is defined as the length of time from the date of diagnosis through the end of follow up that patients are free from breast cancer-related mortality.
Measured: Up to 5 years
Overall survival (OS)
The length of time from the date of diagnosis through the end of follow up that patients are still alive.
Measured: 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)
This assessment is a 16 item questionnaire using Likert scale (0-4) measured with each ctDNA blood draw. Score ranges from 0-64 with higher scores indicative of higher quality of life / asymptomatic from cancer-related therapy.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start19 Apr 2022
- Primary completion16 Oct 2024
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Natera, Inc.
- Responsible party
- Principal investigator, Emilia J Diego, MD, University of Pittsburgh
- Investigators
- Priscilla McAuliffe, MD, PhD, Principal investigator, UPMC Magee Women's Hospital, UPMC Hillman Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05914792
- Sponsor's protocol ID
- HCC 22-088
- Other IDs
- STUDY21100091
- Status last verified
- Apr 2026
- First submitted
- 13 Jun 2023
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal ctDNA Monitoring in Older Women With ER+ Breast Cancer Who Forego Upfront Surgery in Favor of Primary Endocrine Therapy
- ClinicalTrials.gov ID
- NCT05914792
- Acronym / sponsor ID
- HCC 22-088
- Conditions
- Breast Cancer
- Keywords
- estrogen receptor positive (ER+), progesterone receptor (PR+), early-stage breast cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Natera, Inc.
- Study start
- 19 Apr 2022 (actual)
- Primary completion
- 16 Oct 2024 (actual)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 22 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 70 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of ctDNA positivity
Time frame: Up to 5 years
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.
4 secondary outcomes
Progression-free survival (PFS)
Time frame: Up to 5 years
Breast cancer-specific survival (BCSS)
Time frame: Up to 5 years
Overall survival (OS)
Time frame: 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)
Time frame: Up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Priscilla McAuliffe, MD, PhD principal investigator
UPMC Magee Women's Hospital, UPMC Hillman Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of ctDNA positivity (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.