Breast CancerNCT00086749
Effect of Tamoxifen on Breast Density in Premenopausal Women With Breast Cancer or High Risk for Breast Cancer
An observational study of Breast Cancer, run by Northwestern University at 1 site in United States.
Trial summary
RATIONALE: High estrogen levels may be associated with dense breast tissue and an increased risk of developing breast cancer. Tamoxifen may be effective in reducing breast density by decreasing estrogen levels. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2003to Dec 2007
- 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 20 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women who are initiating tamoxifen on the advice of their treating physician as the sole systemic treatment for breast carcinoma or breast cancer risk reduction
DISEASE CHARACTERISTICS:
- Initiating tamoxifen as the sole systemic treatment for breast cancer OR for breast cancer risk reduction
- Undergoing mammography at least annually
- No bilateral breast cancer or stage IV breast cancer
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age
- 20 to 45
Sex
- Female
Menopausal status
- Premenopausal
- No change in menstrual patterns within the past 6 months
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Other
- Not pregnant or nursing
- No planned pregnancy within the next 5 years
- No medical or psychiatric disorder that would preclude giving informed consent
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No prior chemotherapy for breast cancer
Endocrine therapy
- See Disease Characteristics
- No prior tamoxifen for more than 1 month in duration
Radiotherapy
- Not specified
Surgery
- Not specified
Trial locations and contacts
1 site in 1 country.
United States1 site
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, 60611-3013
About this study
Official title: A Prospective Study Of The Effect Of Tamoxifen On Breast Density In Premenopausal Women
RATIONALE: High estrogen levels may be associated with dense breast tissue and an increased risk of developing breast cancer. Tamoxifen may be effective in reducing breast density by decreasing estrogen levels.
PURPOSE: This phase I trial is studying how well tamoxifen works in reducing breast density in premenopausal women with breast cancer or at high risk of developing breast cancer.
Read the detailed description
OBJECTIVES:
Primary
- Determine whether breast density, as measured by digital mammography, decreases in premenopausal women receiving tamoxifen for breast cancer or for breast cancer risk reduction.
- Determine whether breast density, as determined by a trained mammographer, decreases in patients treated with this drug.
- Correlate tamoxifen-induced symptoms in estrogen target tissue with change in salivary steroids in patients treated with this drug.
Secondary
- Determine the effect of this drug on salivary steroids in regularly cycling and amenorrheic patients.
- Correlate changes in breast density with tamoxifen-induced alterations in sex steroid levels, as measured in the saliva, of patients treated with this drug.
OUTLINE: Patients receive oral tamoxifen once daily. Treatment continues for 5 years in the absence of disease metastasis (patients with known breast cancer) or a diagnosis of breast cancer (patients undergoing risk reduction).
Patients undergo mammography to determine breast density at baseline, at 6 and 12 months, and then annually for 4 years. Patients also collect daily salivary samples during the 30-day periods surrounding the imaging studies to measure salivary estradiol and progesterone levels. The results of the salivary hormone studies are correlated with density changes at study completion.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.
- Conditions
- Breast Cancer
- Keywords
- breast cancer, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer
- 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 |
|---|---|---|
| Tamoxifen group | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2004 (estimated)
- Study startFeb 2003
- Primary completionDec 2007
- Study completionDec 2007
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 Northwestern 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
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Seema A. Khan, MD, Principal investigator, Robert H. Lurie Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00086749
- Sponsor's protocol ID
- NCI 00B2
- Other IDs
- NU-NCI-00B2, NCI-00B2
- Status last verified
- Jul 2012
- First submitted
- 8 Jul 2004
- Last updated
- 11 Jul 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study Of The Effect Of Tamoxifen On Breast Density In Premenopausal Women
- ClinicalTrials.gov ID
- NCT00086749
- Acronym / sponsor ID
- NCI 00B2
- Conditions
- Breast Cancer
- Keywords
- breast cancer, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2003
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 12 Jul 2004 (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.
RATIONALE: High estrogen levels may be associated with dense breast tissue and an increased risk of developing breast cancer. Tamoxifen may be effective in reducing breast density by decreasing estrogen levels.
PURPOSE: This phase I trial is studying how well tamoxifen works in reducing breast density in premenopausal women with breast cancer or at high risk of developing breast cancer.
Detailed description
OBJECTIVES:
Primary
- Determine whether breast density, as measured by digital mammography, decreases in premenopausal women receiving tamoxifen for breast cancer or for breast cancer risk reduction.
- Determine whether breast density, as determined by a trained mammographer, decreases in patients treated with this drug.
- Correlate tamoxifen-induced symptoms in estrogen target tissue with change in salivary steroids in patients treated with this drug.
Secondary
- Determine the effect of this drug on salivary steroids in regularly cycling and amenorrheic patients.
- Correlate changes in breast density with tamoxifen-induced alterations in sex steroid levels, as measured in the saliva, of patients treated with this drug.
OUTLINE: Patients receive oral tamoxifen once daily. Treatment continues for 5 years in the absence of disease metastasis (patients with known breast cancer) or a diagnosis of breast cancer (patients undergoing risk reduction).
Patients undergo mammography to determine breast density at baseline, at 6 and 12 months, and then annually for 4 years. Patients also collect daily salivary samples during the 30-day periods surrounding the imaging studies to measure salivary estradiol and progesterone levels. The results of the salivary hormone studies are correlated with density changes at study completion.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tamoxifen group | – | – |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women who are initiating tamoxifen on the advice of their treating physician as the sole systemic treatment for breast carcinoma or breast cancer risk reduction
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
Not reported in the source record.
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 11 Jul 2012.
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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.
Seema A. Khan, MD principal investigator
Robert H. Lurie Cancer Center
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, run by Northwestern 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?
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 11 Jul 2012. 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.
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 11 Jul 2012.