BRCA1 Mutation CarrierNCT01219075
Soy Isoflavones Supplementation in Treating Women at High Risk For or With Breast Cancer
A study testing soy isoflavones, questionnaire administration and magnetic resonance imaging in people with BRCA1 Mutation Carrier and BRCA2 Mutation Carrier, run by University of Southern California at 1 site in United States.
Trial summary
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of soy isoflavones supplements may prevent or treat early stage breast cancer. PURPOSE: This clinical trial studies soy isoflavones supplementation in treating women at high risk for or with breast cancer. Read more about this study
- Who is it for?
- Ages 30 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- BRCA1 Mutation Carrier, BRCA2 Mutation Carrier, Ductal Breast Carcinoma in Situ
- What is being tested?
- soy isoflavones, questionnaire administration and magnetic resonance imaging
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2010to 24 Nov 2022
- Phase
- Interventional
- 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 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women at high risk for breast cancer, defined as any of the following groups:
- Five year Gail risk > 1.7%
- Known BRCA1/BRCA2 mutation carrier
- Family history consistent with hereditary breast cancer
- Prior biopsy exhibiting atypical hyperplasia or lobular carcinoma in situ (LCIS)
- History of invasive breast cancer or ductal carcinoma in situ (DCIS) and have completed standard therapy including tamoxifen/aromatase inhibitor or will not be treated with tamoxifen/aromatase inhibitor
- Signed Informed Consent
Who cannot join
- Metastatic breast cancer
- Undergoing treatment (chemotherapy, radiation, or SERMs)
- Pregnancy or breast-feeding, or planning to become pregnant within one year prior to study entry
- Regular soy consumers (i.e., < once per week of soy food, soy supplements or other products)
- Known food allergies such as to soy or nuts
- Not willing to avoid soy foods/supplements during study period
Show all 9Show fewer
- Current users of exogenous hormones or oral contraceptive or planning to use exogenous hormones during the duration of the study
- Cannot stop taking aspirin or NSAIDs within a week of breast biopsy
- Active participant in other ongoing trials
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Southern California
Los Angeles, California, 90033-0804
About this study
Official title: Soy Treatment for High-risk Women
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of soy isoflavones supplements may prevent or treat early stage breast cancer. PURPOSE: This clinical trial studies soy isoflavones supplementation in treating women at high risk for or with breast cancer.
Read the detailed description
PRIMARY OBJECTIVES: I. To assess whether magnetic resonance imaging (MRI) volume (equivalent to 3-dimensional mammographic density) is reduced in high-risk women or those with invasive breast cancer or DCIS who are supplemented daily with soy (5p mg total isoflavones as aglycone) compared to placebo (microcrystalline cellulose) tablets for 1 year.II. To assess whether cell proliferation and apoptosis, as measured by Ki67 and caspase 3 staining, respectively, of breast epithelial cells is altered with soy treatment.SECONDARY OBJECTIVES: I. To assess whether other intermediate molecular markers including estrogen receptor alpha (ER alpha) and ER beta differ between women supplemented with soy vs placebo. OUTLINE: Patients are randomized to 1 of 2 treatment arms.ARM I: Patients receive oral soy isoflavones supplement once daily for12 months in the absence of disease progression.ARM II: Patients receive oral placebo once daily for 12 months in the absence of disease progression.
- Conditions
- BRCA1 Mutation Carrier, BRCA2 Mutation Carrier, Ductal Breast Carcinoma in Situ, Lobular Breast Carcinoma in Situ, Stage IA Breast Cancer, Stage IB Breast Cancer
- Being tested
- soy isoflavones, placebo, questionnaire administration, magnetic resonance imaging, biopsy
- Medical subject headings
- Carcinoma, Intraductal, Noninfiltrating, Breast Carcinoma In Situ, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
soy isoflavonesDietary supplement
Also called NovaSoy, soy phytoestrogens
Given orally
placeboOther
Also called PLCB
Given orally
questionnaire administrationOther
Ancillary studies
magnetic resonance imagingProcedure or surgery
Also called MRI, NMR imaging, NMRI, nuclear magnetic resonance imaging
Correlative studies
biopsyProcedure or surgery
Also called biopsies
Correlative studies
immunohistochemistry staining methodOther
Also called immunohistochemistry
Correlative studies
laboratory biomarker analysisOther
Correlative studies
mammographyProcedure or surgery
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients receive oral soy isoflavones supplement once daily for 12 months in the absence of disease progression. Receives: Dietary Supplement: soy isoflavones; Other: questionnaire administration; Procedure: magnetic resonance imaging; Procedure: biopsy; Other: immunohistochemistry staining method; Other: laboratory biomarker analysis; Procedure: mammography |
| Arm II | Placebo comparator | Patients receive oral placebo once daily for 12 months in the absence of disease progression. Receives: Other: placebo; Other: questionnaire administration; Procedure: magnetic resonance imaging; Procedure: biopsy; Other: immunohistochemistry staining method; Other: laboratory biomarker analysis; Procedure: mammography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with reduced MRI volume (MRIV)
Measured: At completion of 12 months on the study
Secondary outcomes (1)
Percentage of cells that stain positive for Ki67, caspase 3, ratio of Ki67/caspase, ER alpha and ER beta
Measured: At completion of 12 months on the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2010 (estimated)
- Study start1 Jul 2010
- Primary completion24 Nov 2022
- Study completion24 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BRCA1 Mutation CarrierStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), California Breast Cancer Research Program
- Responsible party
- Sponsor
- Investigators
- Anna Wu, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01219075
- Sponsor's protocol ID
- 1B-10-6
- Other IDs
- NCI-2010-01847
- Status last verified
- Nov 2023
- First submitted
- 7 Oct 2010
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Wu AH, Spicer D, Garcia A, Tseng CC, Hovanessian-Larsen L, Sheth P, Martin SE, Hawes D, Russell C, MacDonald H, Tripathy D, Su MY, Ursin G, Pike MC. Double-Blind Randomized 12-Month Soy Intervention Had No Effects on Breast MRI Fibroglandular Tissue Density or Mammographic Density. Cancer Prev Res (Phila). 2015 Oct;8(10):942-51. doi: 10.1158/1940-6207.CAPR-15-0125. Epub 2015 Aug 14.
PubMed 26276750
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Soy Treatment for High-risk Women
- ClinicalTrials.gov ID
- NCT01219075
- Acronym / sponsor ID
- 1B-10-6
- Conditions
- BRCA1 Mutation Carrier, BRCA2 Mutation Carrier, Ductal Breast Carcinoma in Situ, Lobular Breast Carcinoma in Situ, Stage IA Breast Cancer, Stage IB Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), California Breast Cancer Research Program
- Study start
- 1 Jul 2010 (actual)
- Primary completion
- 24 Nov 2022 (actual)
- Study completion
- 24 Nov 2022 (actual)
- First posted
- 13 Oct 2010 (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: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of soy isoflavones supplements may prevent or treat early stage breast cancer. PURPOSE: This clinical trial studies soy isoflavones supplementation in treating women at high risk for or with breast cancer.
Detailed description
PRIMARY OBJECTIVES: I. To assess whether magnetic resonance imaging (MRI) volume (equivalent to 3-dimensional mammographic density) is reduced in high-risk women or those with invasive breast cancer or DCIS who are supplemented daily with soy (5p mg total isoflavones as aglycone) compared to placebo (microcrystalline cellulose) tablets for 1 year.II. To assess whether cell proliferation and apoptosis, as measured by Ki67 and caspase 3 staining, respectively, of breast epithelial cells is altered with soy treatment.SECONDARY OBJECTIVES: I. To assess whether other intermediate molecular markers including estrogen receptor alpha (ER alpha) and ER beta differ between women supplemented with soy vs placebo. OUTLINE: Patients are randomized to 1 of 2 treatment arms.ARM I: Patients receive oral soy isoflavones supplement once daily for12 months in the absence of disease progression.ARM II: Patients receive oral placebo once daily for 12 months in the absence of disease progression.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Dietary Supplement: soy isoflavones, Other: questionnaire administration, Procedure: magnetic resonance imaging, Procedure: biopsy, Other: immunohistochemistry staining method, Other: laboratory biomarker analysis, Procedure: mammographyPatients receive oral soy isoflavones supplement once daily for 12 months in the absence of disease progression. |
| Arm II | Placebo comparator | Other: placebo, Other: questionnaire administration, Procedure: magnetic resonance imaging, Procedure: biopsy, Other: immunohistochemistry staining method, Other: laboratory biomarker analysis, Procedure: mammographyPatients receive oral placebo once daily for 12 months in the absence of disease progression. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Women at high risk for breast cancer, defined as any of the following groups:
- Five year Gail risk > 1.7%
- Known BRCA1/BRCA2 mutation carrier
- Family history consistent with hereditary breast cancer
- Prior biopsy exhibiting atypical hyperplasia or lobular carcinoma in situ (LCIS)
Key exclusion criteria (9 listed)
- Metastatic breast cancer
- Undergoing treatment (chemotherapy, radiation, or SERMs)
- Pregnancy or breast-feeding, or planning to become pregnant within one year prior to study entry
- Regular soy consumers (i.e., < once per week of soy food, soy supplements or other products)
- Known food allergies such as to soy or nuts
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 |
|---|---|---|
| soy isoflavonesAlso: NovaSoy, soy phytoestrogensGiven orally | Dietary supplement | Arm I |
| placeboAlso: PLCBGiven orally | Other | Arm II |
| questionnaire administrationAncillary studies | Other | Arm I, Arm II |
| magnetic resonance imagingAlso: MRI, NMR imaging, NMRI, nuclear magnetic resonance imagingCorrelative studies | Procedure or surgery | Arm I, Arm II |
| biopsyAlso: biopsiesCorrelative studies | Procedure or surgery | Arm I, Arm II |
| immunohistochemistry staining methodAlso: immunohistochemistryCorrelative studies | Other | Arm I, Arm II |
| laboratory biomarker analysisCorrelative studies | Other | Arm I, Arm II |
| mammographyCorrelative studies | Procedure or surgery | Arm I, Arm II |
Primary outcome
Number of participants with reduced MRI volume (MRIV)
Time frame: At completion of 12 months on the study
1 secondary outcome
Percentage of cells that stain positive for Ki67, caspase 3, ratio of Ki67/caspase, ER alpha and ER beta
Time frame: At completion of 12 months on the study
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 18 Nov 2023.
- Derived from this study: PubMed 26276750Wu AH, Spicer D, Garcia A, Tseng CC, Hovanessian-Larsen L, Sheth P, Martin SE, Hawes D, Russell C, MacDonald H, Tripathy D, Su MY, Ursin G, Pike MC. Double-Blind Randomized 12-Month Soy Intervention Had No Effects on Breast MRI Fibroglandular Tissue Density or Mammographic Density. Cancer Prev Res (Phila). 2015 Oct;8(10):942-51. doi: 10.1158/1940-6207.CAPR-15-0125. Epub 2015 Aug 14.
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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.
Anna Wu principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing soy isoflavones, questionnaire administration and magnetic resonance imaging in people with BRCA1 Mutation Carrier and BRCA2 Mutation Carrier, run by University of Southern California 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 7 inclusion and 9 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 18 Nov 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.
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?
Number of participants with reduced MRI volume (MRIV) (time frame: At completion of 12 months on the study). 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 NCT01219075, 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 18 Nov 2023; AzTrials last refreshed its copy on 8 Nov 2026.