Breast CancerNCT03719495
Evaluation of Endocrine Therapy Effects of Host Immunity in Early Stage Breast Cancer
An observational study of Breast Cancer and Estrogen Receptor-positive Breast Cancer, run by Duke University at 1 site in United States.
Trial summary
The purpose of this research study is to learn about the effects that standard of care endocrine therapies have on the immune system's response to cancer by looking at the number and types of immune cells present and how they function in women with early stage estrogen receptor positive (ER+) breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Estrogen Receptor-positive Breast Cancer, Healthy
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jun 2019to 31 Jul 2023
- 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 18 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Pre-menopausal and postmenopausal women with breast cancer who are initiating endocrine therapy or aromatase inhibitors. Pre-menopausal and postmenopausal healthy women who are not on any hormonal birth control.
Who may be able to join
- No known significant health problems.
- Available to participate for the planned duration of the investigational study (6 months).
- Able and willing to complete the informed consent process.
- Agree to have blood stored for future studies.
- Premenopausal women must have a history of regular menses defined as occuring monthly at regular intervals.
- Postmenopausal women are defined as:
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- prior bilateral oophorectomy
- 60 or older
- age less than 60 years
- amenorrheic for 12 months or more in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression
- and follicle-stimulating hormone (FSH) and plasma estradiol in the postmenopausal range.
- Early stage breast cancer including T1-3, N0-3.
- Histologically documented estrogen receptor positive adenocarcinoma of the breast that is (any progesterone status allowed):
- ER positive defined as ≥ 10% tumor cells positive for ER by immunohistochemistry (IHC), irrespective of staining intensity.
- HER2 negative status is determined by:
- IHC 1+, as defined by incomplete membrane staining that is faint/barely perceptible and within >10% of invasive tumor cells, OR
- IHC 0, as defined by no staining observed or membrane staining that is incomplete and is faint/barely perceptible and within ≤ 10% of the invasive tumor cells, OR
- FISH negative based on:
- Single-probe average HEr2 copy number <4.0 signals/cell, OR
- Dual-probe HER2/CEP17 ratio <2.0 with an average HER2 copy number <4.0 signals/cell.
- Patients should have plans to initiate standard of care endocrine therapy in the adjuvant setting per primary provider.
- Patients can have had neoadjuvant or adjuvant chemotherapy with resolution of all hematologic toxicity to less than grade 1 by CTCAE v4.0 (e.g. Hg ≥10d/dL, Platelets 75,000mm3, Neutrophil >1500mm3).
- Patients should be willing to provide an archival tumor specimen from their definitive surgery.
- Able and willing to complete the informed consent process.
- Available to participate for the planned duration of the study (6 months).
- Agree to have bio-specimens stored for future research.
Who cannot join
- Relapsed or metastatic breast cancer.
- History of cancer or concurrent active malignancy (excluding basal cell skin cancer, resected squamous cell carcinoma of the skin).
- Receipt of neoadjuvant or previous endocrine therapy including ovarian function suppression in the neoadjuvant setting.
- Current use of hormonal birth control (copper IUD allowed) or estrogen replacement therapy.
- Known to have a condition in which repeated blood draws pose more than minimal risk for the subject such as hemophilia, other severe coagulation disorders or significantly impaired venous access.
- Concurrent enrollment in a therapeutic clinical trial involving novel drug therapies
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- Active autoimmune disease that has required systemic treatment in past year (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, or similar treatment) is not considered a form of systemic treatment.
- Immunodeficient subjects, E.G., receiving systemic steroid therapy or any other form of immunosuppressive therapy within 30 days prior to the first dose of endocrine therapy treatment
- Concurrent use of other oncologic therapies in the adjuvant setting other than bisphosphonates
- Active or ongoing infection
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease, active bleeding diatheses including any subjects known to have evidence of acute or chronic hepatitis B, hepatitis C or human immunodeficiency virus (HIV), or psychiatric illness / social situations that would limit compliance with study requirements or compromise the ability of the subject to give written informed consent.
- Pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Evaluation of the Effects of Endocrine Therapies on Immune Cell Repertoire and Function in Early Stage Estrogen Receptor Positive Breast Cancer Patients
The purpose of this research study is to learn about the effects that standard of care endocrine therapies have on the immune system's response to cancer by looking at the number and types of immune cells present and how they function in women with early stage estrogen receptor positive (ER+) breast cancer.
Read the detailed description
The study will enroll mainly subjects with estrogen receptor positive breast cancer that have completed surgery and radiation therapy to remove the tumor(s) and have not yet started standard treatment endocrine therapy. There is one group of subjects who have not been diagnosed with cancer. The information learned from this study will help doctors understand more about how the immune system responds to endocrine therapy for early stage breast cancer in people who are estrogen receptor positive with the goal of developing improved therapies that harness the immune system.
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Pre-menopausal women as healthy controls will be recruited on Duke University Campus and Duke University Hospital. | |
| Cohort 2 | Postmenopausal women as healthy controls will be recruited on Duke University Campus and Duke University Hospital. | |
| Cohort 3 | Pre-menopausal women initiating tamoxifen after standard of care local-regional therapy after surgery +/- radiation. | |
| Cohort 4 | Pre-menopausal women initiating ovarian suppression plus aromatase inhibition after surgery +/- radiation. | |
| Cohort 5 | Postmenopausal women initiating endocrine therapy with aromatase inhibition after standard of care surgery +/- radiation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in estrogen levels in response to adjuvant endocrine therapy.
Phenotypic and functional characterization of T cell and B cell populations will be performed on peripheral blood mononuclear cells.
Measured: 2 years
Secondary outcomes (7)
Changes in regulatory T cells in premenopausal vs postmenopausal women treated with aromatase inhibitors.
Blood will be assessed at each time point to understand the impact of endocrine therapy on regulatory T cells.
Measured: Through study completion, approximately 1 year.
Changes in T cell activation/ V cell activation in premenopausal vs postmenopausal women treated with aromatase inhibitors.
Blood will be assessed at each time point to understand the impact of endocrine therapy in T cell activation/ V cell activation.
Measured: Through study completion, approximately 1 year.
Changes in T cell exhaustion in premenopausal vs postmenopausal women treated with aromatase inhibitors.
Blood will be assessed at each time point to understand the impact of endocrine therapy in T cell exhaustion.
Measured: Through study completion, approximately 1 year.
Changes in myeloid-derived suppressor cells in premenopausal vs postmenopausal women treated with aromatase inhibitors.
Blood will be assess at each time point to understand the impact of endocrine therapy on myeloid-derived suppressor cells.
Measured: Through study completion, approximately 1 year.
Changes in physical manifestations with the Patient-Reported Outcomes Measurement Information System (PROMIS) fatigue survey to measure response to adjuvant endocrine therapy.
PROMIS Fatigue quality of life survey will be given at each time point.
Measured: Through study completion, approximately 1 year.
Changes in inflammatory markers with Patient-Reported Arthralgia Inventory (PRAI) to measure response to adjuvant endocrine therapy.
16-item Patient-Reported Arthralgia Inventory (PRAI) quality of life survey will be given at each time point.
Measured: Through study completion, approximately 1 year.
Assess changes in RNA express in response to endocrine therapy.
RNA expression of PMBCs will be performed to assess changes in gene expression due to endocrine therapy.
Measured: Through study completion, approximately 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2018
- Study start19 Jun 2019
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
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 Duke 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
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Susan Dent, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03719495
- Sponsor's protocol ID
- Pro00100408
- Status last verified
- May 2024
- First submitted
- 15 Oct 2018
- Last updated
- 16 May 2024
- 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 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Endocrine Therapies on Immune Cell Repertoire and Function in Early Stage Estrogen Receptor Positive Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT03719495
- Acronym / sponsor ID
- Pro00100408
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 19 Jun 2019 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 25 Oct 2018 (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 purpose of this research study is to learn about the effects that standard of care endocrine therapies have on the immune system's response to cancer by looking at the number and types of immune cells present and how they function in women with early stage estrogen receptor positive (ER+) breast cancer.
Detailed description
The study will enroll mainly subjects with estrogen receptor positive breast cancer that have completed surgery and radiation therapy to remove the tumor(s) and have not yet started standard treatment endocrine therapy. There is one group of subjects who have not been diagnosed with cancer. The information learned from this study will help doctors understand more about how the immune system responds to endocrine therapy for early stage breast cancer in people who are estrogen receptor positive with the goal of developing improved therapies that harness the immune system.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –Pre-menopausal women as healthy controls will be recruited on Duke University Campus and Duke University Hospital. |
| Cohort 2 | – | –Postmenopausal women as healthy controls will be recruited on Duke University Campus and Duke University Hospital. |
| Cohort 3 | – | –Pre-menopausal women initiating tamoxifen after standard of care local-regional therapy after surgery +/- radiation. |
| Cohort 4 | – | –Pre-menopausal women initiating ovarian suppression plus aromatase inhibition after surgery +/- radiation. |
| Cohort 5 | – | –Postmenopausal women initiating endocrine therapy with aromatase inhibition after standard of care surgery +/- radiation. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pre-menopausal and postmenopausal women with breast cancer who are initiating endocrine therapy or aromatase inhibitors. Pre-menopausal and postmenopausal healthy women who are not on any hormonal birth control.
Key inclusion criteria (26 listed)
- No known significant health problems.
- Available to participate for the planned duration of the investigational study (6 months).
- Able and willing to complete the informed consent process.
- Agree to have blood stored for future studies.
- Premenopausal women must have a history of regular menses defined as occuring monthly at regular intervals.
Key exclusion criteria (12 listed)
- Relapsed or metastatic breast cancer.
- History of cancer or concurrent active malignancy (excluding basal cell skin cancer, resected squamous cell carcinoma of the skin).
- Receipt of neoadjuvant or previous endocrine therapy including ovarian function suppression in the neoadjuvant setting.
- Current use of hormonal birth control (copper IUD allowed) or estrogen replacement therapy.
- Known to have a condition in which repeated blood draws pose more than minimal risk for the subject such as hemophilia, other severe coagulation disorders or significantly impaired venous access.
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
Changes in estrogen levels in response to adjuvant endocrine therapy.
Time frame: 2 years
Phenotypic and functional characterization of T cell and B cell populations will be performed on peripheral blood mononuclear cells.
7 secondary outcomes
Changes in regulatory T cells in premenopausal vs postmenopausal women treated with aromatase inhibitors.
Time frame: Through study completion, approximately 1 year.
Changes in T cell activation/ V cell activation in premenopausal vs postmenopausal women treated with aromatase inhibitors.
Time frame: Through study completion, approximately 1 year.
Changes in T cell exhaustion in premenopausal vs postmenopausal women treated with aromatase inhibitors.
Time frame: Through study completion, approximately 1 year.
Changes in myeloid-derived suppressor cells in premenopausal vs postmenopausal women treated with aromatase inhibitors.
Time frame: Through study completion, approximately 1 year.
Changes in physical manifestations with the Patient-Reported Outcomes Measurement Information System (PROMIS) fatigue survey to measure response to adjuvant endocrine therapy.
Time frame: Through study completion, approximately 1 year.
Changes in inflammatory markers with Patient-Reported Arthralgia Inventory (PRAI) to measure response to adjuvant endocrine therapy.
Time frame: Through study completion, approximately 1 year.
Assess changes in RNA express in response to endocrine therapy.
Time frame: Through study completion, approximately 1 year.
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 16 May 2024.
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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.
Susan Dent, MD principal investigator
Duke 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 Estrogen Receptor-positive Breast Cancer, run by Duke 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 26 inclusion and 12 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 16 May 2024. 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?
Changes in estrogen levels in response to adjuvant endocrine therapy. (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 16 May 2024.