NCT01219075 is a NA clinical trial of soy isoflavones in BRCA1 Mutation Carrier, sponsored by University of Southern California.

Who is sponsoring NCT01219075?

NCT01219075 is sponsored by University of Southern California.

What drugs are being tested in NCT01219075?

Interventions in NCT01219075: soy isoflavones, placebo, questionnaire administration, magnetic resonance imaging, biopsy, immunohistochemistry staining method, laboratory biomarker analysis, mammography.

What condition does NCT01219075 study?

NCT01219075 studies BRCA1 Mutation Carrier, BRCA2 Mutation Carrier, Ductal Breast Carcinoma in Situ, Lobular Breast Carcinoma in Situ, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer.

Is NCT01219075 still recruiting?

NCT01219075 is currently completed. Last updated 18 November 2023.

Last reviewed 2023-11-18 · How we verify

NCT01219075

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Soy Isoflavones Supplementation in Treating Women at High Risk For or With Breast Cancer

Completed NA Last updated 18 November 2023

What this trial tests

NA trial testing soy isoflavones in BRCA1 Mutation Carrier in 110 participants. Completed in 24 November 2022.

Timeline

1 July 2010

Primary endpoint
24 November 2022

24 November 2022

Quick facts

Lead sponsor	University of Southern California
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	110
Start date	1 July 2010
Primary completion	24 November 2022
Estimated completion	24 November 2022
Sites	1 location across United States

Drugs / interventions tested

soy isoflavones — full drug profile →
placebo
questionnaire administration
magnetic resonance imaging
biopsy — full drug profile →
immunohistochemistry staining method
laboratory biomarker analysis — full drug profile →
mammography

Conditions studied

BRCA1 Mutation Carrier — all drugs for BRCA1 Mutation Carrier →
BRCA2 Mutation Carrier — all drugs for BRCA2 Mutation Carrier →
Ductal Breast Carcinoma in Situ — all drugs for Ductal Breast Carcinoma in Situ →
Lobular Breast Carcinoma in Situ — all drugs for Lobular Breast Carcinoma in Situ →

Sponsor

University of Southern California

Who can join

Adults 30 to 75, female only, with BRCA1 Mutation Carrier or BRCA2 Mutation Carrier. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

Flavonoids: New Frontier for Immuno-Regulation and Breast Cancer Control.
Sudhakaran M, Sardesai S, Doseff AI. · · 2019 · cited 56× · PMID 30995775 · DOI 10.3390/antiox8040103
Exploring the Biological Activity and Mechanism of Xenoestrogens and Phytoestrogens in Cancers: Emerging Methods and Concepts.
Wang X, Ha D, Yoshitake R, Chan YS, et al · · 2021 · cited 27× · PMID 34445499 · DOI 10.3390/ijms22168798
Double-Blind Randomized 12-Month Soy Intervention Had No Effects on Breast MRI Fibroglandular Tissue Density or Mammographic Density.
Wu AH, Spicer D, Garcia A, Tseng CC, et al · · 2015 · cited 25× · PMID 26276750 · DOI 10.1158/1940-6207.capr-15-0125
Targeting Breast Cancer Stem Cells Using Naturally Occurring Phytoestrogens.
Nguyen M, Osipo C. · · 2022 · cited 24× · PMID 35743256 · DOI 10.3390/ijms23126813
Hereditary cancer syndromes as model systems for chemopreventive agent development.
Walcott FL, Patel J, Lubet R, Rodriguez L, et al · · 2016 · cited 13× · PMID 26970132 · DOI 10.1053/j.seminoncol.2015.09.015

Verify or expand the search:

Other trials of soy isoflavones

Trials testing the same drug.

NCT06047145 — Evaluation of Soy Isoflavones on Skin Ageing Parameters · NA · completed

Other recruiting trials for BRCA1 Mutation Carrier

Currently open trials in the same condition.

NCT02208375 — mTORC1/2 Inhibitor AZD2014 or the Oral AKT Inhibitor AZD5363 for Recurrent Endometrial and Ovarian · Phase 1 · active not recruiting

Other University of Southern California trials

Trials by the same sponsor.

NCT07288463 — Hearing Loss and Genetic Risks for Alzheimer's Disease and Related Dementia · NA · not yet recruiting
NCT05914233 — Non-invasive Ultrasound Retinal Stimulation for Vision Restoration · NA · not yet recruiting
NCT06163664 — Role of ChatGPT in Vestibular Schwannoma Management · NA · withdrawn
NCT07332312 — A Culturally Informed Patient Navigation Program (CFPN) to Reduce Delays Between Diagnosis and Treatment in American Ind · NA · not yet recruiting
NCT07290478 — Encouraging Older Adults and Adults With Serious Illness to Designate a Health Care Proxy · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01219075 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Southern California
Last refreshed: 18 November 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01219075.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing