Breast CancerNCT04074720
Prospective Breast Cancer Biospecimen Collection
An observational study of Breast Cancer and Invasive Breast Cancer, run by Thomas Jefferson University at 1 site in United States.
Trial summary
Tissue will be procured during a standard of care procedure the patient will already be scheduled to undergo. A one time blood draw will be performed at this time and an optional rectal swab for biome analysis may occur. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Invasive Breast Cancer, Carcinoma in Situ of the Breast
- What is being tested?
- Tissue Sample collection, Blood Sample Collection and Rectal Swab
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2018to 1 Jul 2028
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults (≥18 years old) with newly diagnosed in situ carcinoma or invasive breast cancer, or patients with primary breast cancer with metastasis to the brain. Up to 200 newly diagnosed breast cancer patients, and 36 patients with brain metastases.
Who may be able to join
- Adults >18 years old at time of consent
- Subject must be capable to giving informed consent or have an acceptable surrogate capable of giving consent on the subject behalf.
- Patients with carcinoma in situ or invasive breast cancer
- Patient must be undergoing one of the following:
- definitive surgical tumor resection for breast cancer OR
- placement of a vascular access device as a prelude to neoadjuvant therapy for breast cancer OR
- neurosurgical resection of a brain metastasis from primary breast cancer.
Who cannot join
- <18 years old
- Not able to give informed consent and does not have acceptable surrogate capable to giving informed consent.
- Active drug/alcohol dependence or abuse history
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Nicole Simone, 2159556702, Nicole.Simone@jefferson.edu
About this study
Tissue will be procured during a standard of care procedure the patient will already be scheduled to undergo. A one time blood draw will be performed at this time and an optional rectal swab for biome analysis may occur. Follow Up will only consist of chart review to determine date of recurrence, metastases, and/or death
Read the detailed description
This is a breast cancer biospecimen and possible metastasis procurement study with the goal of obtaining specimens appropriately for genomic and proteomic analysis. Other than reviewing and signing the consent form by the participants in the study, and the study-specific blood tissue procurement and blood draw (and optional biome specimen), all care and clinical encounters will be as per standard of care. There are four times when tissue may be procured and an optional biome specimen collection depending on the treatment course the treating team decides upon. The technique will be chosen based on physician discretion, patient medical treatment, and patient preference. Treatment regimen will consist of tumor sampling/extraction, one blood draw, optional biome specimen collection, and sample storing. This is a single arm study; all participants will have tissue and blood sample procured for biospecimen analysis and repository. Patients have the option to donate a biome specimen as well. Providing the biome sample is optional and will not influence eligibility to patient participation in this study. There will be no assignment or randomization to different treatment groups.
- Being tested
- Tissue Sample collection, Blood Sample Collection, Rectal Swab
- Keywords
- Breast Cancer, Tumor Tissue Collection, Serum Collection, Plasma Collection, Fresh Tissue Collection, Fixed Tissue Collection, Translational Research, Biospecimen Collection, Surgical Resection, Vascular Access Placement
- Medical subject headings
- Breast Neoplasms, Breast Carcinoma In Situ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tissue Sample collectionProcedure or surgery
Tissue sample collected following standard of care procedure patient was already scheduled to have
Blood Sample CollectionOther
A one time sample of blood will be collected on day of standard of care procedure
Rectal SwabOther
optional rectal swab may be collected on day of standard of care procedure
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Newly Diagnosed Breast Cancer Patients | Tissue will be procured during a standard of care procedure the patient will already have scheduled. A one time blood draw will be performed at this time and an optional rectal swab for biome analysis may occur. Follow up will only consist of chart review to determine date of recurrence, metastases, and/or death. Receives: Procedure: Tissue Sample collection; Other: Blood Sample Collection; Other: Rectal Swab | |
| Group 2: Patients with Brain Metastases from Primary Breast Cancer | The brain metastasis specimen experiments will use tissue from 36 patients (12 per subtype: estrogen positive, Her-neu-2 positive, and triple negative). Tissue will be procured during a standard of care procedure the patient will already have scheduled. A one time blood draw will be performed at this time and an optional rectal swab for biome analysis may occur. Follow up will only consist of chart review to determine date of recurrence, metastases, and/or death. Receives: Procedure: Tissue Sample collection; Other: Blood Sample Collection; Other: Rectal Swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor biomarker identification
Collected biospecimens will be analyzed using current laboratory techniques to identify the presence of breast cancer biomarkers such as estrogen receptor (ER) and human epidermal growth factor receptor 2 (HER2).
Measured: Up to 5 years
Secondary outcomes (1)
Laboratory-based breast cancer tumor genomic profile
Genomic profile will be based on laboratory analysis of the collected tumor tissue biospecimens to identify how genes interact with the tumor and its environment.
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 posted30 Aug 2019
- Study start10 May 2018
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jul 2028 (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.
- 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicole Simone, MD, Principal investigator, Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04074720
- Sponsor's protocol ID
- 16D.674
- Other IDs
- JT 8877
- Status last verified
- Nov 2025
- First submitted
- 1 Aug 2019
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Breast Cancer Biospecimen Collection
- ClinicalTrials.gov ID
- NCT04074720
- Acronym / sponsor ID
- 16D.674
- Keywords
- Breast Cancer, Tumor Tissue Collection, Serum Collection, Plasma Collection, Fresh Tissue Collection, Fixed Tissue Collection, Translational Research, Biospecimen Collection
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 10 May 2018 (actual)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 30 Aug 2019 (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.
Tissue will be procured during a standard of care procedure the patient will already be scheduled to undergo. A one time blood draw will be performed at this time and an optional rectal swab for biome analysis may occur. Follow Up will only consist of chart review to determine date of recurrence, metastases, and/or death
Detailed description
This is a breast cancer biospecimen and possible metastasis procurement study with the goal of obtaining specimens appropriately for genomic and proteomic analysis. Other than reviewing and signing the consent form by the participants in the study, and the study-specific blood tissue procurement and blood draw (and optional biome specimen), all care and clinical encounters will be as per standard of care. There are four times when tissue may be procured and an optional biome specimen collection depending on the treatment course the treating team decides upon. The technique will be chosen based on physician discretion, patient medical treatment, and patient preference. Treatment regimen will consist of tumor sampling/extraction, one blood draw, optional biome specimen collection, and sample storing. This is a single arm study; all participants will have tissue and blood sample procured for biospecimen analysis and repository. Patients have the option to donate a biome specimen as well. Providing the biome sample is optional and will not influence eligibility to patient participation in this study. There will be no assignment or randomization to different treatment groups.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Newly Diagnosed Breast Cancer Patients | – | Procedure: Tissue Sample collection, Other: Blood Sample Collection, Other: Rectal SwabTissue will be procured during a standard of care procedure the patient will already have scheduled. A one time blood draw will be performed at this time and an optional rectal swab for biome analysis may occur. Follow up will only consist of chart review to determine date of recurrence, metastases, and/or death. |
| Group 2: Patients with Brain Metastases from Primary Breast Cancer | – | Procedure: Tissue Sample collection, Other: Blood Sample Collection, Other: Rectal SwabThe brain metastasis specimen experiments will use tissue from 36 patients (12 per subtype: estrogen positive, Her-neu-2 positive, and triple negative). Tissue will be procured during a standard of care procedure the patient will already have scheduled. A one time blood draw will be performed at this time and an optional rectal swab for biome analysis may occur. Follow up will only consist of chart review to determine date of recurrence, metastases, and/or death. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults (≥18 years old) with newly diagnosed in situ carcinoma or invasive breast cancer, or patients with primary breast cancer with metastasis to the brain. Up to 200 newly diagnosed breast cancer patients, and 36 patients with brain metastases.
Key inclusion criteria (7 listed)
- Adults >18 years old at time of consent
- Subject must be capable to giving informed consent or have an acceptable surrogate capable of giving consent on the subject behalf.
- Patients with carcinoma in situ or invasive breast cancer
- Patient must be undergoing one of the following:
Key exclusion criteria (3 listed)
- <18 years old
- Not able to give informed consent and does not have acceptable surrogate capable to giving informed consent.
- Active drug/alcohol dependence or abuse history
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tissue Sample collectionTissue sample collected following standard of care procedure patient was already scheduled to have | Procedure or surgery | Group 1: Newly Diagnosed Breast Cancer Patients, Group 2: Patients with Brain Metastases from Primary Breast Cancer |
| Blood Sample CollectionA one time sample of blood will be collected on day of standard of care procedure | Other | Group 1: Newly Diagnosed Breast Cancer Patients, Group 2: Patients with Brain Metastases from Primary Breast Cancer |
| Rectal Swaboptional rectal swab may be collected on day of standard of care procedure | Other | Group 1: Newly Diagnosed Breast Cancer Patients, Group 2: Patients with Brain Metastases from Primary Breast Cancer |
Primary outcome
Tumor biomarker identification
Time frame: Up to 5 years
Collected biospecimens will be analyzed using current laboratory techniques to identify the presence of breast cancer biomarkers such as estrogen receptor (ER) and human epidermal growth factor receptor 2 (HER2).
1 secondary outcome
Laboratory-based breast cancer tumor genomic profile
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 3 Dec 2025.
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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.
Nicole Simone, MD principal investigator
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
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 and Invasive Breast Cancer, run by Thomas Jefferson University 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 7 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: looking for participants now, as of the sponsor's last update on 3 Dec 2025. 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?
Contact Nicole Simone, MD (215-955-6702, Nicole.Simone@jefferson.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor biomarker identification (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 3 Dec 2025.