Triple Negative Breast CancerNCT03165487
Comparison of the Breast Tumor Microenvironment
An observational study of Triple Negative Breast Cancer and Hormone Receptor Positive Malignant Neoplasm of Breast, run by Columbia University at 1 site in United States.
Trial summary
The goal of the project is to identify a molecular signature of tumor stroma from "normal" adjacent breast tissue obtained prospectively at the time of breast conserving surgery before and after receiving intraoperative radiation therapy (IORT) in subjects that have luminal A and triple negative breast cancer. Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Triple Negative Breast Cancer, Hormone Receptor Positive Malignant Neoplasm of Breast
- What is being tested?
- Breast tissue collection and Blood sample collection
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2017to 15 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Subjects will be recruited from the outpatient Breast Surgery and Radiation Oncology Clinics of Columbia University
Who may be able to join
- Female, age greater than or equal to 40
- Core biopsy proven invasive breast carcinoma or ductal carcinoma in situ (DCIS), all subtypes excluding invasive lobular carcinoma due to increased risk for multifocal disease
- Human epidermal growth factor receptor 2 (HER2) negative regardless of hormone receptor status
- Clinically less than or equal to 3cm unifocal lesion
- Clinically node negative
- Must have diagnostic mammogram performed within last 6 months
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- Eastern Cooperative Oncology Group Performance Status (ECOG PS) less than or equal to 1
- Appropriate renal, liver, and hematologic lab values
- Ability to give informed consent
Who cannot join
- Multifocal disease
- Clinically N1 disease at diagnosis
- Invasive lobular carcinoma
- Metastatic disease
- Patients for whom RT would be contraindicated (e.g., connective tissue disorder or prior ipsilateral breast radiation)
- Patients with known BRCA1/2 mutations
- Pregnant or nursing
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Irving Medical Center
New York, New York, 10032
About this study
Official title: Differential Comparison of the Breast Tumor Microenvironment Between Luminal A and Triple Negative Breast Cancer With and Without Radiation Treatment
The goal of the project is to identify a molecular signature of tumor stroma from "normal" adjacent breast tissue obtained prospectively at the time of breast conserving surgery before and after receiving intraoperative radiation therapy (IORT) in subjects that have luminal A and triple negative breast cancer. IORT is considered as being standard of care.
Read the detailed description
There is evidence that the normal tissue around a tumor plays a role in determining how the tumor behaves, including how it will respond to treatments and how likely it is to recur. In breast cancer, radiation is used to decrease the chance of recurrence in the area where the tumor is removed. This risk of recurrence varies between different types of breast cancer. The investigators seek to study the proteins produced in normal tissue surrounding breast tumors. The tissue will be taken from women who are receiving radiation to the breast at the time of their surgery (known as intraoperative radiation), one specimen taken before radiation and one after. A new process will be used to stabilize the tissue rapidly and allow the proteins to be identified before they break down. This will allow us to identify differences in the proteins produced by cells before and after radiation and between two types of breast cancers, luminal A (less likely to recur) and triple negative (more likely to recur). Identifying these differences in proteins may allow them to be used in the future as markers to predict the likelihood of tumors recurring.
- Being tested
- Breast tissue collection, Blood sample collection
- Keywords
- Triple Negative Breast Cancer, microenvironment, IORT, Hormone Receptor Positive, HER 2 negative
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast tissue collectionOther
During Breast Conservation Surgery, one sample will be collected before and after IORT.
Blood sample collectionOther
Blood will be collected before and after IORT, and at the two week follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Luminal A Breast Cancer | Luminal A Breast cancer subjects will have tissue specimens and blood collected before and after IORT during the Breast conserving surgery. Receives: Other: Breast tissue collection; Other: Blood sample collection | |
| Triple Negative Breast Cancer | Triple Negative breast cancer subjects will have tissue specimens and blood collected before and after IORT during the Breast conserving surgery. Receives: Other: Breast tissue collection; Other: Blood sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with significant mean percent change in Tumor Infiltrating Lymphocytes (TILs)
This outcome measure is designed to measure the amount of TILs in newly diagnosed luminal A and Triple Negative Breast Cancer (TNBC) tumors. The mean percent change in TILS in tumor tissue from initial core biopsy samples will be compared with pathology samples from definitive surgery after IORT between the two different breast cancer sub-types.
Measured: Two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2017
- Study start28 Sep 2017
- Primary completion15 Jun 2021
- Study completion15 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple Negative Breast CancerStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eileen Connolly, Columbia University
- Investigators
- Eileen Connolly, MD, Principal investigator, Assistant Professor of Radiation Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03165487
- Sponsor's protocol ID
- AAAO7708
- Status last verified
- Oct 2026
- First submitted
- 22 May 2017
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differential Comparison of the Breast Tumor Microenvironment Between Luminal A and Triple Negative Breast Cancer With and Without Radiation Treatment
- ClinicalTrials.gov ID
- NCT03165487
- Acronym / sponsor ID
- AAAO7708
- Keywords
- Triple Negative Breast Cancer, microenvironment, IORT, Hormone Receptor Positive, HER 2 negative
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 28 Sep 2017 (actual)
- Primary completion
- 15 Jun 2021 (actual)
- Study completion
- 15 Jun 2021 (actual)
- First posted
- 24 May 2017 (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.
The goal of the project is to identify a molecular signature of tumor stroma from "normal" adjacent breast tissue obtained prospectively at the time of breast conserving surgery before and after receiving intraoperative radiation therapy (IORT) in subjects that have luminal A and triple negative breast cancer. IORT is considered as being standard of care.
Detailed description
There is evidence that the normal tissue around a tumor plays a role in determining how the tumor behaves, including how it will respond to treatments and how likely it is to recur. In breast cancer, radiation is used to decrease the chance of recurrence in the area where the tumor is removed. This risk of recurrence varies between different types of breast cancer. The investigators seek to study the proteins produced in normal tissue surrounding breast tumors. The tissue will be taken from women who are receiving radiation to the breast at the time of their surgery (known as intraoperative radiation), one specimen taken before radiation and one after. A new process will be used to stabilize the tissue rapidly and allow the proteins to be identified before they break down. This will allow us to identify differences in the proteins produced by cells before and after radiation and between two types of breast cancers, luminal A (less likely to recur) and triple negative (more likely to recur). Identifying these differences in proteins may allow them to be used in the future as markers to predict the likelihood of tumors recurring.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Luminal A Breast Cancer | – | Other: Breast tissue collection, Other: Blood sample collectionLuminal A Breast cancer subjects will have tissue specimens and blood collected before and after IORT during the Breast conserving surgery. |
| Triple Negative Breast Cancer | – | Other: Breast tissue collection, Other: Blood sample collectionTriple Negative breast cancer subjects will have tissue specimens and blood collected before and after IORT during the Breast conserving surgery. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be recruited from the outpatient Breast Surgery and Radiation Oncology Clinics of Columbia University
Key inclusion criteria (9 listed)
- Female, age greater than or equal to 40
- Core biopsy proven invasive breast carcinoma or ductal carcinoma in situ (DCIS), all subtypes excluding invasive lobular carcinoma due to increased risk for multifocal disease
- Human epidermal growth factor receptor 2 (HER2) negative regardless of hormone receptor status
- Clinically less than or equal to 3cm unifocal lesion
- Clinically node negative
Key exclusion criteria (7 listed)
- Multifocal disease
- Clinically N1 disease at diagnosis
- Invasive lobular carcinoma
- Metastatic disease
- Patients for whom RT would be contraindicated (e.g., connective tissue disorder or prior ipsilateral breast radiation)
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 |
|---|---|---|
| Breast tissue collectionDuring Breast Conservation Surgery, one sample will be collected before and after IORT. | Other | Luminal A Breast Cancer, Triple Negative Breast Cancer |
| Blood sample collectionBlood will be collected before and after IORT, and at the two week follow-up. | Other | Luminal A Breast Cancer, Triple Negative Breast Cancer |
Primary outcome
Number of subjects with significant mean percent change in Tumor Infiltrating Lymphocytes (TILs)
Time frame: Two weeks
This outcome measure is designed to measure the amount of TILs in newly diagnosed luminal A and Triple Negative Breast Cancer (TNBC) tumors. The mean percent change in TILS in tumor tissue from initial core biopsy samples will be compared with pathology samples from definitive surgery after IORT between the two different breast cancer sub-types.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 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.
Eileen Connolly, MD principal investigator
Assistant Professor of Radiation Oncology
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 Triple Negative Breast Cancer and Hormone Receptor Positive Malignant Neoplasm of Breast, run by Columbia 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 9 inclusion and 7 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: finished, as of the sponsor's last update on 21 Oct 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of subjects with significant mean percent change in Tumor Infiltrating Lymphocytes (TILs) (time frame: Two weeks). 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 21 Oct 2026.