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
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
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- 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.
- 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