Women With Suspected or Confirmed Recurrent Breast CancerNCT02530008
Breast Cancer 2-PREVENT Translational Center of Excellence (TCE) - Metastatic Markers of Recurrent Tumor Phenotype for Breast Cancer
An observational study of Women With Suspected or Confirmed Recurrent Breast Cancer, run by Abramson Cancer Center at Penn Medicine at 2 sites in United States.
Trial summary
This is a cohort study of women with suspected or confirmed recurrent breast cancer, with accessible tumor by standard clinical biopsy, prior to starting a new therapy for recurrent metastatic disease. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Women With Suspected or Confirmed Recurrent Breast Cancer
- How many people
- 600 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2013to Oct 2026
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: women with recurrent breast cancer
Who may be able to join
- Histologically-confirmed breast cancer - based upon pathology report of the primary or metastatic diagnosis
- Recurrent breast cancer (local, regional, or distant disease) - as determined by either clinical,radiological, or pathological evaluation
- Willing to undergo or provide tissue from a recent biopsy of recurrent tumor for both clinical and research testing
- Willing to undergo blood specimen collection
- Age 18 or over and are able to give informed consent
Who cannot join
- Non-metastatic breast cancer (stage I, II or III)
- Anticoagulation that cannot be interrupted for the purpose of study evaluation (patients must have normal INR and PTT at the time of study biopsy)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Lancaster General Hospital
Lancaster, Pennsylvania, 17602
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
This is a cohort study of women with suspected or confirmed recurrent breast cancer, with accessible tumor by standard clinical biopsy, prior to starting a new therapy for recurrent metastatic disease. Study participants will be ascertained from the population of all persons greater than eighteen years of age receiving care at the clinical practices of the Rowan Breast Center (RBC) at the University of Pennsylvania. The overarching goal of this study is to identify the genetic and molecular markers of molecular evolution identified in patients who have progressed from a primary diagnosis of breast cancer to recurrent, metastatic disease. As an observational study, this study seeks to gather data regarding the molecular and genetic changes that a primary cancer undergoes as a patient's cancer recurs and ultimately progresses. We anticipate enrolling 600 women with recurrent breast cancer who meet eligibility requirements for this study. Participation in this study will include the following: a biopsy and blood collection, completion of the study questionnaire, an optional bone marrow aspiration, and repeat collection of blood, offer of a research biopsy and a optional bone marrow aspirate collection at each progression time point. The study participants' medical information will be updated and changes in disease status will be captured on a regular basis.
What is being measured
The primary outcome is the main question the study is designed to answer.
subjects with detectable DTCs/CTCs
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2015 (estimated)
- Study startOct 2013
- Primary completionOct 2024
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Women With Suspected or Confirmed Recurrent Breast CancerStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe 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
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Angela DeMichele, MD, Principal investigator, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02530008
- Sponsor's protocol ID
- UPCC 30113
- Status last verified
- Jan 2026
- First submitted
- 19 Aug 2015
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast Cancer 2-PREVENT Translational Center of Excellence (TCE) - Metastatic Markers of Recurrent Tumor Phenotype for Breast Cancer
- ClinicalTrials.gov ID
- NCT02530008
- Acronym / sponsor ID
- UPCC 30113
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- Oct 2013 (actual)
- Primary completion
- Oct 2024 (actual)
- Study completion
- Oct 2026 (estimated)
- First posted
- 20 Aug 2015 (estimated)
- 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 is a cohort study of women with suspected or confirmed recurrent breast cancer, with accessible tumor by standard clinical biopsy, prior to starting a new therapy for recurrent metastatic disease. Study participants will be ascertained from the population of all persons greater than eighteen years of age receiving care at the clinical practices of the Rowan Breast Center (RBC) at the University of Pennsylvania. The overarching goal of this study is to identify the genetic and molecular markers of molecular evolution identified in patients who have progressed from a primary diagnosis of breast cancer to recurrent, metastatic disease. As an observational study, this study seeks to gather data regarding the molecular and genetic changes that a primary cancer undergoes as a patient's cancer recurs and ultimately progresses. We anticipate enrolling 600 women with recurrent breast cancer who meet eligibility requirements for this study. Participation in this study will include the following: a biopsy and blood collection, completion of the study questionnaire, an optional bone marrow aspiration, and repeat collection of blood, offer of a research biopsy and a optional bone marrow aspirate collection at each progression time point. The study participants' medical information will be updated and changes in disease status will be captured on a regular basis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- women with recurrent breast cancer
Key inclusion criteria (5 listed)
- Histologically-confirmed breast cancer - based upon pathology report of the primary or metastatic diagnosis
- Recurrent breast cancer (local, regional, or distant disease) - as determined by either clinical,radiological, or pathological evaluation
- Willing to undergo or provide tissue from a recent biopsy of recurrent tumor for both clinical and research testing
- Willing to undergo blood specimen collection
- Age 18 or over and are able to give informed consent
Key exclusion criteria (2 listed)
- Non-metastatic breast cancer (stage I, II or III)
- Anticoagulation that cannot be interrupted for the purpose of study evaluation (patients must have normal INR and PTT at the time of study biopsy)
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
subjects with detectable DTCs/CTCs
Time frame: 2 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 22 Jan 2026.
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.
Angela DeMichele, MD principal investigator
Abramson Cancer Center at Penn Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Women With Suspected or Confirmed Recurrent Breast Cancer, run by Abramson Cancer Center at Penn Medicine at 2 sites 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 5 inclusion and 2 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 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
subjects with detectable DTCs/CTCs (time frame: 2 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 22 Jan 2026.