Breast CancerPhase 2NCT00579826
Study of Breast Cancer Prevention by Letrozole in High Risk Women
A Phase 2 study testing Letrozole in people with Breast Cancer, run by Carol Fabian, MD at 1 site in United States.
Trial summary
This is a multi-institution double-blind placebo-controlled trial whose main objective is to determine if 6 months of letrozole (2.5 mg daily) can reduce proliferation as assessed by Ki-67 in high risk postmenopausal women on systemic hormone replacement therapy who have random periareolar fine needle aspiration… Read more about this study
- Who is it for?
- Ages 30 to 69 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Letrozole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Aug 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 69 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Post-menopausal women at high risk for development of breast cancer
- stable dose of hormone replacement therapy
- have cytomorphologic evidence of hyperplasia +/- atypia and Ki-67 expression >1.5% in benign breast epithelial cells acquired by RPFNA
- Serum level of 25-hydroxyvitamin D of at least 30 ng/ml prior to study entry
- Willing to have a repeat random periareolar fine needle aspiration (RPFNA) and mammogram at 6 months and 12 months (if participating in the open label portion of the study) following initiation of study drug
Who cannot join
- Prior history of osteoporosis or osteoporotic fracture.
- Prior history of invasive breast cancer or other invasive cancer within five years from date of study entry.
- Current and chronic use of cyclooxygenase-2 (COX-2) specific inhibitors or NSAIDs
- Receiving treatment for rheumatoid arthritis or fibromyalgia
- Current history of poorly controlled migraines or perimenopausal symptoms
- Currently receiving other investigational agents.
- Receipt of more than 6 months of an aromatase inhibitor (anastrozole, exemestane, letrozole, etc.) at any time in the past.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
This is a multi-institution double-blind placebo-controlled trial whose main objective is to determine if 6 months of letrozole (2.5 mg daily) can reduce proliferation as assessed by Ki-67 in high risk postmenopausal women on systemic hormone replacement therapy who have random periareolar fine needle aspiration (RPFNA) evidence of hyperplasia with atypia or borderline atypia, and a minimum Ki-67 of >1.5%.
The primary hypothesis is that proliferation and expression of other estrogen response genes will be favorably modulated by six months of letrozole relative to placebo without substantially increasing hot flashes or worsening overall quality of life.
Read the detailed description
Subsequent to the 6 month RPFNA for assessment of biomarkers, toxicity and quality of life assessments, all women may receive optional open-label letrozole for an additional 6 months, followed by a third RPFNA and biomarker
- Conditions
- Breast Cancer
- Being tested
- Letrozole, Placebo
- 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
Also called Letrozole(Femara)
Letrozole 2.5 mg tablet daily. Then optional open label letrozole for another 6 months.
PlaceboDrug
Placebo tablet daily for 6 months then optional open label letrozole for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Letrozole | Experimental | Letrozole, 2.5 mg daily for 6 months Receives: Drug: Letrozole |
| Placebo | Placebo comparator | Placebo, daily for 6 months Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Proliferation Rate (Ki-67 by Immunocytochemistry) From Baseline to 6 Months
Change in proliferation rate (percent positively stained cells for Ki-67 antigen by immunocytochemistry) in benign breast epithelial cells acquired by random periareolar fine needle aspiration (RPFNA) from women at high risk for the development of breast cancer.
Measured: Baseline to 6 Months
Secondary outcomes (2)
Assessment of Change in Morphology by the Masood Score.
Masood score is a semi-quantitative index of increasing abnormality, thus higher values are worse. Range 6 to 24.
Based on Masood S, Frykberg ER, McLellan GL, Scalapino MC, Mitchum DG, Bullard JB. Prospective evaluation of radiologically directed fine-needle aspiration biopsy of nonpalpable breast lesions. Cancer 1990; 66:1480-7.
Measured: Baseline to 6 Months
Change in Mammographic Density From Baseline to 6 Months..
Percent area of the breast considered to be at increased density, as determined by the computer program Cumulus..
Measured: Baseline to 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2007 (estimated)
- Study startOct 2006
- Primary completionMar 2015
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carol Fabian, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis, National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Carol Fabian, MD, University of Kansas Medical Center
- Investigators
- Carol J Fabian, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00579826
- Sponsor's protocol ID
- 10587
- Other IDs
- CFEM345AUS45, 5R01CA122577-03
- Status last verified
- May 2023
- First submitted
- 18 Dec 2007
- Last updated
- 12 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: Global results will be published.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Breast Cancer Prevention by Letrozole in High Risk Women
- ClinicalTrials.gov ID
- NCT00579826
- Acronym / sponsor ID
- 10587
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Carol Fabian, MDUniversity, hospital or other
- Collaborators
- Novartis, National Cancer Institute (NCI)
- Study start
- Oct 2006
- Primary completion
- Mar 2015 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 24 Dec 2007 (estimated)
- Results
- Posted 23 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-institution double-blind placebo-controlled trial whose main objective is to determine if 6 months of letrozole (2.5 mg daily) can reduce proliferation as assessed by Ki-67 in high risk postmenopausal women on systemic hormone replacement therapy who have random periareolar fine needle aspiration (RPFNA) evidence of hyperplasia with atypia or borderline atypia, and a minimum Ki-67 of >1.5%.
The primary hypothesis is that proliferation and expression of other estrogen response genes will be favorably modulated by six months of letrozole relative to placebo without substantially increasing hot flashes or worsening overall quality of life.
Detailed description
Subsequent to the 6 month RPFNA for assessment of biomarkers, toxicity and quality of life assessments, all women may receive optional open-label letrozole for an additional 6 months, followed by a third RPFNA and biomarker
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Letrozole | Experimental | Drug: LetrozoleLetrozole, 2.5 mg daily for 6 months |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo, daily for 6 months |
Who may qualify
- Ages
- 30 to 69 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Post-menopausal women at high risk for development of breast cancer
- stable dose of hormone replacement therapy
- have cytomorphologic evidence of hyperplasia +/- atypia and Ki-67 expression >1.5% in benign breast epithelial cells acquired by RPFNA
- Serum level of 25-hydroxyvitamin D of at least 30 ng/ml prior to study entry
- Willing to have a repeat random periareolar fine needle aspiration (RPFNA) and mammogram at 6 months and 12 months (if participating in the open label portion of the study) following initiation of study drug
Key exclusion criteria (7 listed)
- Prior history of osteoporosis or osteoporotic fracture.
- Prior history of invasive breast cancer or other invasive cancer within five years from date of study entry.
- Current and chronic use of cyclooxygenase-2 (COX-2) specific inhibitors or NSAIDs
- Receiving treatment for rheumatoid arthritis or fibromyalgia
- Current history of poorly controlled migraines or perimenopausal symptoms
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 |
|---|---|---|
| LetrozoleAlso: Letrozole(Femara)Letrozole 2.5 mg tablet daily. Then optional open label letrozole for another 6 months. | Drug | Letrozole |
| PlaceboPlacebo tablet daily for 6 months then optional open label letrozole for 6 months. | Drug | Placebo |
Primary outcome
Change in Proliferation Rate (Ki-67 by Immunocytochemistry) From Baseline to 6 Months
Time frame: Baseline to 6 Months
Change in proliferation rate (percent positively stained cells for Ki-67 antigen by immunocytochemistry) in benign breast epithelial cells acquired by random periareolar fine needle aspiration (RPFNA) from women at high risk for the development of breast cancer.
2 secondary outcomes
Assessment of Change in Morphology by the Masood Score.
Time frame: Baseline to 6 Months
Change in Mammographic Density From Baseline to 6 Months..
Time frame: Baseline to 6 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Global results will be published.
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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.
Carol J Fabian, MD principal investigator
University of Kansas Medical Center
1 site 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 Breast Cancer, run by Carol Fabian, MD 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 5 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 12 Jun 2023. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 23 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Proliferation Rate (Ki-67 by Immunocytochemistry) From Baseline to 6 Months (time frame: Baseline to 6 Months). 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 12 Jun 2023.