Breast CancerPhase 2NCT01276704
Prevention Strategy for Pre-Menopausal Women at High Risk for Development of Breast Cancer
A Phase 2 study testing secoisolariciresinol in people with Breast Cancer, run by Carol Fabian, MD at 7 sites in United States.
Trial summary
The investigators will study the effect of 12 months of SDG (Brevail) vs placebo on women at increased risk for development of breast cancer. Read more about this study
- Who is it for?
- Ages 21 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- secoisolariciresinol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 7 sitesUnited States
- Study dates
- Jan 2011to Jul 2017
- 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 21 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- RPFNA performed in the follicular portion (day 1-10) of the menstrual cycle. Note that day 1 is defined as the first day of bleeding.
- RPFNA specimen exhibits hyperplasia +/- atypia (Masood score of ≥13) with ≥500 cells on the cytology slide.
- Ki-67 ≥2% positivity (≥500 cells).
- Willing to continue without oral contraceptives throughout the duration of the study participation (12 months). Non-oral contraceptives are permissible. If heterosexually active, must be agreeable to use some non-hormonal form of contraception during the trial or husband or partner must have had a vasectomy. (Safety of SDG during pregnancy has not been documented).
- Have reasonable organ function as documented by metabolic chemistry profile.
- Willing to undergo a history and physical at baseline and 12 months and be contacted periodically by the trial coordinator during the 12 month study period.
- Willing to have blood drawn at baseline and twelve months.
- Able to understand and willing to provide informed consent for the RPFNA's and study participation.
Who cannot join
None listed.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Northwestern University Medical Center
Chicago, Illinois, 60611
Ohio State Unviersity Medical Center
Columbus, Ohio, 43210
University of Kansas Medical Center
Kansas City, Kansas, 66160
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
University of Washington
Seattle, Washington, 98109-1023
About this study
Official title: Flaxseed Lignan as a Prevention Strategy for Pre-Menopausal Women at High Risk for Development of Breast Cancer
The investigators will study the effect of 12 months of SDG (Brevail) vs placebo on women at increased risk for development of breast cancer.
Read the detailed description
The investigators would like to see if women at increased risk for breast cancer are likely to tolerate SDG daily for 12 months without significant side effects or changes in their menstrual cycles. The investigators would also like to determine if Brevail® can reduce breast cell proliferation in pre-menopausal women.
- Conditions
- Breast Cancer
- Being tested
- Placebo, secoisolariciresinol
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
The placebo contains same filler materials as commercially available Brevail® but without active SDG.
secoisolariciresinolDrug
Also called SDG
1 capsule daily of secoisolariciresinol diglycoside (SDG)50mg
| Study group | Role | What they receive |
|---|---|---|
| flaxseed lignan, SDG | Experimental | Secoisolariciresinol diglycoside Receives: Drug: secoisolariciresinol |
| Placebo | Placebo comparator | Matched Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Percent of Breast Epithelial Cells With Ki-67 Immunocytochemical Expression
Change over the course of study in the percent of breast epithelial cells expressing the proliferation marker Ki- 67/MIB-1 in hyperplastic benign breast tissue acquired by random periareolar fine needle aspiration pre-study and post-study.
Measured: 12 months
Secondary outcomes (2)
Change in Gene Expression
Gene expression in breast epithelial cells assessed by RT-qPCR. Change in expression (fold-change for 12-months compared to baseline value) was evaluated by cluster analysis and used to define "responders" and non-responders" based on favorable or non-favorable modulation of a set of 12 relevant genes.
Specifically, data for change in ESR1 (codes for estrogen receptor alpha) are shown.
Measured: 12 months
Breast Cancer Prevention Trial (BCPT) Symptom Checklist
Quality of life as measured by the Breast Cancer Prevention Trial (BCPT) Symptom Checklist, completed at baseline and end of study by each participant.
Responses to 43 questions (with each question given a value from 0 to 4, higher score being worse) are clustered into seven domains to yield an average score per domain. These seven category scores are then averaged to provide a final average score (range by definition, 0 to 4). Change in score over the course of the intervention per individual is then assessed. By definition, change in score theoretically ranges from -4 to +4.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionJul 2017
- Study completionJul 2017
Why it stopped: accrual rate lower than anticipated; funding expired
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carol Fabian, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Lignan Research Inc.
- Responsible party
- Sponsor-investigator, Carol Fabian, MD, University of Kansas Medical Center
- Investigators
- Carol Fabian, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01276704
- Sponsor's protocol ID
- 12377
- Status last verified
- Aug 2023
- First submitted
- 6 Jan 2011
- Last updated
- 21 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: Global results will be published.
Publications
Fabian CJ, Khan SA, Garber JE, Dooley WC, Yee LD, Klemp JR, Nydegger JL, Powers KR, Kreutzjans AL, Zalles CM, Metheny T, Phillips TA, Hu J, Koestler DC, Chalise P, Yellapu NK, Jernigan C, Petroff BK, Hursting SD, Kimler BF. Randomized Phase IIB Trial of the Lignan Secoisolariciresinol Diglucoside in Premenopausal Women at Increased Risk for Development of Breast Cancer. Cancer Prev Res (Phila). 2020 Jul;13(7):623-634. doi: 10.1158/1940-6207.CAPR-20-0050. Epub 2020 Apr 20.
PubMed 32312713
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flaxseed Lignan as a Prevention Strategy for Pre-Menopausal Women at High Risk for Development of Breast Cancer
- ClinicalTrials.gov ID
- NCT01276704
- Acronym / sponsor ID
- 12377
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: accrual rate lower than anticipated; funding expired
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Carol Fabian, MDUniversity, hospital or other
- Collaborators
- Lignan Research Inc.
- Study start
- Jan 2011 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 13 Jan 2011 (estimated)
- Results
- Posted 21 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators will study the effect of 12 months of SDG (Brevail) vs placebo on women at increased risk for development of breast cancer.
Detailed description
The investigators would like to see if women at increased risk for breast cancer are likely to tolerate SDG daily for 12 months without significant side effects or changes in their menstrual cycles. The investigators would also like to determine if Brevail® can reduce breast cell proliferation in pre-menopausal women.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| flaxseed lignan, SDG | Experimental | Drug: secoisolariciresinolSecoisolariciresinol diglycoside |
| Placebo | Placebo comparator | Drug: PlaceboMatched Placebo |
Who may qualify
- Ages
- 21 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- RPFNA performed in the follicular portion (day 1-10) of the menstrual cycle. Note that day 1 is defined as the first day of bleeding.
- RPFNA specimen exhibits hyperplasia +/- atypia (Masood score of ≥13) with ≥500 cells on the cytology slide.
- Ki-67 ≥2% positivity (≥500 cells).
- Willing to continue without oral contraceptives throughout the duration of the study participation (12 months). Non-oral contraceptives are permissible. If heterosexually active, must be agreeable to use some non-hormonal form of contraception during the trial or husband or partner must have had a vasectomy. (Safety of SDG during pregnancy has not been documented).
- Have reasonable organ function as documented by metabolic chemistry profile.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| PlaceboThe placebo contains same filler materials as commercially available Brevail® but without active SDG. | Drug | Placebo |
| secoisolariciresinolAlso: SDG1 capsule daily of secoisolariciresinol diglycoside (SDG)50mg | Drug | flaxseed lignan, SDG |
Primary outcome
Change in Percent of Breast Epithelial Cells With Ki-67 Immunocytochemical Expression
Time frame: 12 months
Change over the course of study in the percent of breast epithelial cells expressing the proliferation marker Ki- 67/MIB-1 in hyperplastic benign breast tissue acquired by random periareolar fine needle aspiration pre-study and post-study.
2 secondary outcomes
Change in Gene Expression
Time frame: 12 months
Breast Cancer Prevention Trial (BCPT) Symptom Checklist
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 32312713Fabian CJ, Khan SA, Garber JE, Dooley WC, Yee LD, Klemp JR, Nydegger JL, Powers KR, Kreutzjans AL, Zalles CM, Metheny T, Phillips TA, Hu J, Koestler DC, Chalise P, Yellapu NK, Jernigan C, Petroff BK, Hursting SD, Kimler BF. Randomized Phase IIB Trial of the Lignan Secoisolariciresinol Diglucoside in Premenopausal Women at Increased Risk for Development of Breast Cancer. Cancer Prev Res (Phila). 2020 Jul;13(7):623-634. doi: 10.1158/1940-6207.CAPR-20-0050. Epub 2020 Apr 20.
- 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 Fabian, MD principal investigator
University of Kansas Medical Center
7 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 secoisolariciresinol in people with Breast Cancer, run by Carol Fabian, MD at 7 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 8 inclusion and 0 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: stopped early, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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. 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 21 Sep 2023). 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 Percent of Breast Epithelial Cells With Ki-67 Immunocytochemical Expression (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01276704, which also lists 1 linked publication.
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 21 Sep 2023.