Post-MenopausalPhase 2NCT00280930
Letrozole in Postmenopausal Women at Increased Risk for Breast Cancer
A Phase 2 study testing Letrozole in people with Post-Menopausal and Breast Cancer, run by Dana-Farber Cancer Institute at 3 sites in United States.
Trial summary
The purpose of this study to see what happens to breast density in healthy postmenopausal women after treatment with letrozole in one year, compared with treatment with placebo for one year. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Post-Menopausal, Breast Cancer
- What is being tested?
- Letrozole
- How many people
- 60 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2005to not given
- Phase
- Phase 2
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal status defined as: women >55 years of age-no spontaneous menses for at least 12 months; in women < 55 years-no spontaneous menses within the past 12 months and with an FSH level >34.4 IU/I; bilateral oophorectomy
- If subject had prior invasive breast cancer it must have been surgically removed at the time of orginal diagnosis with no evidence of metastases and the primary tumor may be receptive negative, positive or equivocal
- Baseline mammogram (within 6 months) indicating mammographic density occupying >25% (grade 4/5, 5/6 or 6/6) of the breast tissue
- Baseline breast examination demonstrating no clinical evidence of breast cancer
- Acceptable quality DEXA of the L2-L4 postero-anterior (PA) spine and hup must be performed 6 months of randomization
- Subject is willing and able to complete the quality of life questionnaire in either English or French
Who cannot join
- Mammogram suspicious for breast cancer (unless subsequently ruled out)
- Patient's with prior malignancies are eligible unless they have metastatic disease
- Uncontrolled metabolic or endocrine disease, cardiovascular disease or malabsorption syndrome
- Current chemotherapy or immunotherapy
- Hormone replacement therapy or Evista (raloxifene) discontinued less than three months before baseline mammogram
- Tamoxifen therapy discontinued less than six months prior to randomization
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: A Randomized Feasibility Study of Letrozole in Postmenopausal Women at Increased Risk for Development of Breast Cancer as Evidenced by High Breast Density
The purpose of this study to see what happens to breast density in healthy postmenopausal women after treatment with letrozole in one year, compared with treatment with placebo for one year. Other goals of the study include determining if there is a connection between estrogen level and breast density for women in the study and collecting information about the quality of life of those taking part in the study.
Read the detailed description
- Patients will be randomized into one of two study groups. Group 1 will receive letrozole and Group 2 will receive placebo. This is a double-blind trial so neither the patient or the doctor will know what treatment group they are assigned to.
- If the patient is in Group 1 they will take letrozole tablets orally once a day with food for one year. Patients in Group 2 will take a placebo tablet orally once a day with food for one year.
- Patients in both groups will also be given calcium tablets (500mg) and vitamin D tablets (400IU) once a day for one year.
- After the initial screening visits, the patient will return to the clinic at 3, 6, 9 and 12 months (a total of up to 6 visits in the first year). There will also be two follow-up visits at 18 and 24 months. For the 3, 9 and 18 month visits, telephone contact instead of a clinic visit is allowed.
- The following tests and procedures will be performed during these visits: evaluation of side effects; routine blood tests(6, 12, and 24 month visits); urine sample (6 and 12 month visits); complete physical exam including breast exam (12 and 24 month visits); mammogram (12 and 24 month visits); bone marrow density x-ray test (12 and 24 month visits); standard x-rays of the lower back and chest (12 month visit); and a questionnaire about how the patient is feeling (12 and 24 month visits).
- The length of participation in this study is for 1 year of study treatment followed by 1 year of follow-up.
- Conditions
- Post-Menopausal, Breast Cancer
- Being tested
- Letrozole
- Keywords
- letrozole, breast cancer, menopause
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LetrozoleDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the proportion of women with breast density of > grade 4 who have a decrease in breast density of at least one grade after treatment with letrozole for one year.
Secondary outcomes (6)
To determine if the decrease in breast density grade is sustained one year after cessation of therapy
to determine if there is a correlation between plasma estrogen profile and breast density at baseline
to determine the percentage of subjects with breast tissue hyperplasia and atypical hyperplasia before and after therapy
to assess change in estrogen profile from baseline and at 1 year and 1 year after cessation of therapy
to assess the general safety of the utilization of letrozole in healthy post-menopausal women for one year
to compare the effects on menopause-specific quality of life.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2006 (estimated)
- Study startOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-MenopausalStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Massachusetts General Hospital
- Investigators
- Paul Goss, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00280930
- Sponsor's protocol ID
- 05-183
- Other IDs
- NCIC CTG MAP.1
- Status last verified
- Jan 2007
- First submitted
- 23 Jan 2006
- Last updated
- 19 Jan 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Feasibility Study of Letrozole in Postmenopausal Women at Increased Risk for Development of Breast Cancer as Evidenced by High Breast Density
- ClinicalTrials.gov ID
- NCT00280930
- Acronym / sponsor ID
- 05-183
- Conditions
- Post-Menopausal, Breast Cancer
- Keywords
- letrozole, breast cancer, menopause
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Massachusetts General Hospital
- Study start
- Oct 2005
- First posted
- 24 Jan 2006 (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.
The purpose of this study to see what happens to breast density in healthy postmenopausal women after treatment with letrozole in one year, compared with treatment with placebo for one year. Other goals of the study include determining if there is a connection between estrogen level and breast density for women in the study and collecting information about the quality of life of those taking part in the study.
Detailed description
- Patients will be randomized into one of two study groups. Group 1 will receive letrozole and Group 2 will receive placebo. This is a double-blind trial so neither the patient or the doctor will know what treatment group they are assigned to.
- If the patient is in Group 1 they will take letrozole tablets orally once a day with food for one year. Patients in Group 2 will take a placebo tablet orally once a day with food for one year.
- Patients in both groups will also be given calcium tablets (500mg) and vitamin D tablets (400IU) once a day for one year.
- After the initial screening visits, the patient will return to the clinic at 3, 6, 9 and 12 months (a total of up to 6 visits in the first year). There will also be two follow-up visits at 18 and 24 months. For the 3, 9 and 18 month visits, telephone contact instead of a clinic visit is allowed.
- The following tests and procedures will be performed during these visits: evaluation of side effects; routine blood tests(6, 12, and 24 month visits); urine sample (6 and 12 month visits); complete physical exam including breast exam (12 and 24 month visits); mammogram (12 and 24 month visits); bone marrow density x-ray test (12 and 24 month visits); standard x-rays of the lower back and chest (12 month visit); and a questionnaire about how the patient is feeling (12 and 24 month visits).
- The length of participation in this study is for 1 year of study treatment followed by 1 year of follow-up.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Postmenopausal status defined as: women >55 years of age-no spontaneous menses for at least 12 months; in women < 55 years-no spontaneous menses within the past 12 months and with an FSH level >34.4 IU/I; bilateral oophorectomy
- If subject had prior invasive breast cancer it must have been surgically removed at the time of orginal diagnosis with no evidence of metastases and the primary tumor may be receptive negative, positive or equivocal
- Baseline mammogram (within 6 months) indicating mammographic density occupying >25% (grade 4/5, 5/6 or 6/6) of the breast tissue
- Baseline breast examination demonstrating no clinical evidence of breast cancer
- Acceptable quality DEXA of the L2-L4 postero-anterior (PA) spine and hup must be performed 6 months of randomization
Key exclusion criteria (6 listed)
- Mammogram suspicious for breast cancer (unless subsequently ruled out)
- Patient's with prior malignancies are eligible unless they have metastatic disease
- Uncontrolled metabolic or endocrine disease, cardiovascular disease or malabsorption syndrome
- Current chemotherapy or immunotherapy
- Hormone replacement therapy or Evista (raloxifene) discontinued less than three months before baseline mammogram
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 |
|---|---|---|
| Letrozole | Drug | – |
Primary outcome
To determine the proportion of women with breast density of > grade 4 who have a decrease in breast density of at least one grade after treatment with letrozole for one year.
6 secondary outcomes
To determine if the decrease in breast density grade is sustained one year after cessation of therapy
to determine if there is a correlation between plasma estrogen profile and breast density at baseline
to determine the percentage of subjects with breast tissue hyperplasia and atypical hyperplasia before and after therapy
to assess change in estrogen profile from baseline and at 1 year and 1 year after cessation of therapy
to assess the general safety of the utilization of letrozole in healthy post-menopausal women for one year
to compare the effects on menopause-specific quality of life.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2007.
Related trials for Post-Menopausal
Not yet recruiting
The Role of Diet Quality in Sleep Among Women in Postmenopause
Post Menopausal Women
Not yet recruiting
Effect of Hormone Replacement Therapy on Physiotherapy Outcomes in Postmenopausal Women With Frozen Shoulder
Frozen Shoulder, Adhesive Capsulitis
RecruitingObservational study
Observational Study of Bone Complications in People With Post-menopausal Breast Cancer Who Have Stopped Treatment With Denosumab and Aromatase Inhibitors
Breast Cancer
Recruiting
Effects of Amylopectin Chromium Blend on Whole-Body Protein Kinetics and Glucose in Peri/Post-Menopausal Women
Glucose Monitoring, Continuous, Whole Body Protein Metabolism
Active, not recruitingPhase 2
A Study to See Whether Estrogen Can Slow the Growth of Some ER Positive Breast Cancers
Estrogen Receptor Positive Breast Cancer
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.
Paul Goss, MD, PhD principal investigator
Massachusetts General Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Letrozole in people with Post-Menopausal and Breast Cancer, run by Dana-Farber Cancer Institute at 3 sites 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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 19 Jan 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
To determine the proportion of women with breast density of > grade 4 who have a decrease in breast density of at least one grade after treatment with letrozole for one year.. 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 19 Jan 2007.