Breast NeoplasmsNCT01582074
The Ultrasound Study of Tamoxifen
An observational study of Breast Neoplasms, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Background: Studies have shown that changes in breast density (the amount of white area on a woman's mammogram) may be related to changes in breast cancer risk. Currently, there is no ideal way to measure breast density repeatedly over time. Read more about this study
- Who is it for?
- Ages 30 to 70 years, women only
- Conditions the study is for
- Breast Neoplasms
- How many people
- 247 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jul 2011to 1 Jan 2016
- 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 30 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: primary clinical
- All Subjects:
- Aged 30 to 70 at the baseline visit;
- Weight is less than or equal to 350 lbs;
- Not currently pregnant or breastfeeding;
- No breast implants currently;
- No active skin infections or wounds overlying the breast;
- The breast, as visually assessed, can fit through the ultrasound tomography ring (i.e., 20 cm in diameter);
- No serious medical or psychiatric illnesses that would prevent voluntary informed consent.
Cases:
Is planning to take tamoxifen for clinical indications including:
- A referral from a health care professional based on a woman s personal risk of breast cancer (i.e., BRCA1/2 mutation carrier or 5-year predicted risk of breast cancer of greater than or equal to 1.66% according to the gail model [30]; OR
- A diagnosis with invasive, estrogen receptor positive breast cancer, ductal carcinoma in situ, lobular carcinoma in situ, or atypical lobular or ductal hyperplasia affecting one breast; AND
- Has never been diagnosed with breast cancer in the breast contralateral to the current diagnosis;
- Is not receiving or currently planning to take chemotherapy.
Screen-negative Comparison Group:
- The most recent mammogram resulted in recommendations for continued routine screening (i.e., BIRADS diagnostic score of 1 or "2");
- Not currently taking oral contraceptives or menopausal hormone therapy;
- Not been previously diagnosed with breast cancer or received medications or radiation for any type of cancer;
- Not taking medicines (such as tamoxifen or raloxifene) to lower her breast cancer risk.
Trial locations and contacts
1 site in 1 country.
About this study
Background:
- Studies have shown that changes in breast density (the amount of white area on a woman's mammogram) may be related to changes in breast cancer risk. Currently, there is no ideal way to measure breast density repeatedly over time. Researchers want to test whether ultrasound tomography scans can show changes in breast density. To examine these changes, healthy volunteers with no history of breast cancer and women who are taking tamoxifen will have ultrasound tomography scans.
Read more
Objectives:
- To test whether ultrasound tomography scans can show changes in breast density related to tamoxifen exposure.
Eligibility:
- Women between 30 and 70 years of age who are (a) taking tamoxifen or (b) healthy volunteers who have never had breast cancer.
Design:
- All participants will have a screening visit. Healthy volunteers will have one additional study visit; women taking tamoxifen will have three additional study visits.
- All participants will be screened with a physical exam and medical history. They will also give blood and saliva samples. This visit will also include an initial ultrasound tomography breast scan.
- For the healthy volunteers:
- At the study visit (12 months after the screening visit), participants will have a short interview and be weighed. They will also have an ultrasound tomography breast scan and provide a blood sample.
- For the women taking tamoxifen:
- At the second and third visits (1 to 3 months and 3 to 6 months after starting tamoxifen), participants will have a short interview. They will also be weighed and have an ultrasound tomography breast scan.
- At the fourth visit (12 months after starting tamoxifen), participants will have a short interview, weight measurement, and the ultrasound tomography breast scan, and will also provide a blood sample.
- All participants may be followed for up to 5 years after their final study visit.
Read the detailed description
Elevated breast density is one of the strongest risk factors for non-familial breast cancer [1]. Recently, the International Breast Cancer Intervention Study-1 (IBIS-1) trial reported that women whose mammographic density declined by 10% within 12-18 months of initiating tamoxifen chemoprevention also had a marked reduction in cancer risk [2]; however, preliminary data suggested that in 30% of patients, tamoxifen failed to lower density and did not reduce cancer risk. Therefore, we hypothesize that breast density represents a biosensor of tamoxifen response, reflecting bioavailability and action of active drug metabolites. Distinguishing tamoxifen responders from non-responders at the earliest time point would have value for making informed treatment decisions, providing a rationale for continued therapy among responders while sparing non-responders exposure to ineffective treatment. We propose to use a novel ultrasound tomography (UST) scanner to repeatedly assess volumetric breast density among 150 women during their first year of tamoxifen use for clinical indications, including a referral from a health professional based on a woman s personal risk of breast cancer or a diagnosis of atypical lobular or ductal hyperplasia (ALH/ADH), ductal carcinoma in situ (DCIS), lobular carcinoma in situ (LCIS), or invasive breast cancer, to assess whether tamoxifen-related declines in mammographic density found at 12 months can be identified earlier with UST. UST is ideally suited for this application because it produces volumetric data and avoids artifacts secondary to breast compression and exposure to potentially harmful ionizing radiation. For comparison, we will perform UST on a group of 150 age-, race-, and menopausal status-matched women without breast cancer in order to assess changes in UST density over time without tamoxifen exposure. The specific goal of this project is to utilize UST to describe the early time course of volumetric breast density change. The broader objective is to assess the concept of breast density as a biosensor of tamoxifen response and UST as a useful tool for making this determination.
- Conditions
- Breast Neoplasms
- Keywords
- Ultrasound Tomography, Tamoxifen, Breast Cancer, Estrogen Receptor Positive, Breast Density
- 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 |
|---|---|---|
| Cases | women with breast cancer | |
| Controls | Matched women without breast cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in breast density
Change in breast density
Measured: 12 month follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2012 (estimated)
- Study start5 Jul 2011
- Primary completion31 Dec 2015
- Study completion1 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 247 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Gretchen Benson, Ph.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01582074
- Sponsor's protocol ID
- 999911199
- Other IDs
- 11-C-N199
- Status last verified
- Dec 2020
- First submitted
- 19 Apr 2012
- Last updated
- 28 Dec 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Ultrasound Study of Tamoxifen
- ClinicalTrials.gov ID
- NCT01582074
- Acronym / sponsor ID
- 999911199
- Conditions
- Breast Neoplasms
- Keywords
- Ultrasound Tomography, Tamoxifen, Breast Cancer, Estrogen Receptor Positive, Breast Density
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 247 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 5 Jul 2011 (actual)
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- 1 Jan 2016 (actual)
- First posted
- 20 Apr 2012 (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.
Background:
- Studies have shown that changes in breast density (the amount of white area on a woman's mammogram) may be related to changes in breast cancer risk. Currently, there is no ideal way to measure breast density repeatedly over time. Researchers want to test whether ultrasound tomography scans can show changes in breast density. To examine these changes, healthy volunteers with no history of breast cancer and women who are taking tamoxifen will have ultrasound tomography scans.
Objectives:
- To test whether ultrasound tomography scans can show changes in breast density related to tamoxifen exposure.
Eligibility:
- Women between 30 and 70 years of age who are (a) taking tamoxifen or (b) healthy volunteers who have never had breast cancer.
Design:
- All participants will have a screening visit. Healthy volunteers will have one additional study visit; women taking tamoxifen will have three additional study visits.
- All participants will be screened with a physical exam and medical history. They will also give blood and saliva samples. This visit will also include an initial ultrasound tomography breast scan.
- For the healthy volunteers:
- At the study visit (12 months after the screening visit), participants will have a short interview and be weighed. They will also have an ultrasound tomography breast scan and provide a blood sample.
- For the women taking tamoxifen:
- At the second and third visits (1 to 3 months and 3 to 6 months after starting tamoxifen), participants will have a short interview. They will also be weighed and have an ultrasound tomography breast scan.
- At the fourth visit (12 months after starting tamoxifen), participants will have a short interview, weight measurement, and the ultrasound tomography breast scan, and will also provide a blood sample.
- All participants may be followed for up to 5 years after their final study visit.
Detailed description
Elevated breast density is one of the strongest risk factors for non-familial breast cancer [1]. Recently, the International Breast Cancer Intervention Study-1 (IBIS-1) trial reported that women whose mammographic density declined by 10% within 12-18 months of initiating tamoxifen chemoprevention also had a marked reduction in cancer risk [2]; however, preliminary data suggested that in 30% of patients, tamoxifen failed to lower density and did not reduce cancer risk. Therefore, we hypothesize that breast density represents a biosensor of tamoxifen response, reflecting bioavailability and action of active drug metabolites. Distinguishing tamoxifen responders from non-responders at the earliest time point would have value for making informed treatment decisions, providing a rationale for continued therapy among responders while sparing non-responders exposure to ineffective treatment. We propose to use a novel ultrasound tomography (UST) scanner to repeatedly assess volumetric breast density among 150 women during their first year of tamoxifen use for clinical indications, including a referral from a health professional based on a woman s personal risk of breast cancer or a diagnosis of atypical lobular or ductal hyperplasia (ALH/ADH), ductal carcinoma in situ (DCIS), lobular carcinoma in situ (LCIS), or invasive breast cancer, to assess whether tamoxifen-related declines in mammographic density found at 12 months can be identified earlier with UST. UST is ideally suited for this application because it produces volumetric data and avoids artifacts secondary to breast compression and exposure to potentially harmful ionizing radiation. For comparison, we will perform UST on a group of 150 age-, race-, and menopausal status-matched women without breast cancer in order to assess changes in UST density over time without tamoxifen exposure. The specific goal of this project is to utilize UST to describe the early time course of volumetric breast density change. The broader objective is to assess the concept of breast density as a biosensor of tamoxifen response and UST as a useful tool for making this determination.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | –women with breast cancer |
| Controls | – | –Matched women without breast cancer |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- primary clinical
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
Change in breast density
Time frame: 12 month follow-up visit
Change in breast density
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 28 Dec 2020.
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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.
Gretchen Benson, Ph.D. principal investigator
National Cancer Institute (NCI)
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 Neoplasms, run by National Cancer Institute (NCI) 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?
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 28 Dec 2020. 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?
Change in breast density (time frame: 12 month follow-up visit). 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 28 Dec 2020.