Trial reportCancer prevention research (Philadelphia, Pa.)2012
Soy isoflavone supplementation for breast cancer risk reduction: a randomized phase II trial.
Trial report in Cancer prevention research (Philadelphia, Pa.), 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 66 papers, 5 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
66 citing papers in PubMed, 5 syntheses or guidelines pooled it, 171 citations in OpenAlex.
- The Anti-Aging Benefits of Phytoestrogens: Insights and Evidence.Current medicinal chemistry · 2026Pooled it
- Isoflavone Consumption and Risk of Breast Cancer: An Updated Systematic Review with Meta-Analysis of Observational Studies.Nutrients · 2023Pooled it
- Therapy-resistant breast cancer in focus: Clinically relevant mitigation by flavonoids targeting cancer stem cells.Frontiers in pharmacology · 2023Pooled it
- Effect of the Intake of Isoflavones on Risk Factors of Breast Cancer-A Systematic Review of Randomized Controlled Intervention Studies.Nutrients · 2021Pooled it
- Pooled it
- A Randomized Controlled Trial of Soy Isoflavone Intake on Mammographic Density among Malaysian Women.Nutrients · 2023Trial
- Soy isoflavones decrease fibroglandular breast tissue measured by magnetic resonance imaging in premenopausal women: A 2-year randomized double-blind placebo controlled clinical trial.Clinical nutrition ESPEN · 2022Trial
- Impact of 18-Month Soy Protein Supplementation on Steroid Hormones and Serum Biomarkers of Angiogenesis, Apoptosis, and the Growth Hormone/IGF-1 Axis: Results of a Randomized, Placebo-Controlled Trial in Males Following Prostatectomy.Nutrition and cancer · 2022Trial
- Double-Blind Randomized 12-Month Soy Intervention Had No Effects on Breast MRI Fibroglandular Tissue Density or Mammographic Density.Cancer prevention research (Philadelphia, Pa.) · 2015Trial
- The effects of soy supplementation on gene expression in breast cancer: a randomized placebo-controlled study.Journal of the National Cancer Institute · 2014Trial
- Effects of short-term fructooligosaccharide intake on equol production in Japanese postmenopausal women consuming soy isoflavone supplements: a pilot study.Nutrition journal · 2013Trial
- Cytology in nipple aspirate fluid during a randomized soy food intervention among premenopausal women.Nutrition and cancer · 2013Trial
- Biological activities and therapeutic potential of soy isoflavones: a focus on anticancer activity.Molecular biology reports · 2026Review
- Investigating the Epigenetic Therapeutic Potential of Natural Compounds in Cancer.International journal of molecular sciences · 2025Review
- Review
- Perspective: Isoflavones-Intriguing Molecules but Much Remains to Be Learned about These Soybean Constituents.Advances in nutrition (Bethesda, Md.) · 2025Review
- A Review of the Clinical and Epidemiologic Evidence Relevant to the Impact of Postdiagnosis Isoflavone Intake on Breast Cancer Outcomes.Current nutrition reports · 2025Review
- Chemopreventive and therapeutic effects ofFrontiers in pharmacology · 2025Article
- Bioactive nutraceuticals as G4 stabilizers: potential cancer prevention and therapy-a critical review.Naunyn-Schmiedeberg's archives of pharmacology · 2024Review
- Drug repurposing for cancer therapy.Signal transduction and targeted therapy · 2024Review
6 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
18 authors at 4 institutions in 1 country.
Funding
Abstract
Soy isoflavone consumption may protect against breast cancer development. We conducted a phase IIB trial of soy isoflavone supplementation to examine its effect on breast epithelial proliferation and other biomarkers in the healthy high-risk breast. One hundred and twenty-six consented women underwent a random fine-needle aspiration (rFNA); those with 4,000 or more epithelial cells were randomized to a double-blind 6-month intervention of mixed soy isoflavones (PTIG-2535) or placebo, followed by repeat rFNA. Cells were examined for Ki-67 labeling index and atypia. Expression of 28 genes related to proliferation, apoptosis, and estrogenic effect was measured using quantitative reverse transcriptase PCR. Hormone and protein levels were measured in nipple aspirate fluid (NAF). All statistical tests were two-sided. Ninety-eight women were evaluable for Ki-67 labeling index. In 49 treated women, the median Ki-67 labeling index was 1.18 at entry and 1.12 post intervention, whereas in 49 placebo subjects, it was 0.97 and 0.92 (P for between-group change: 0.32). Menopausal stratification yielded similar results between groups, but within premenopausal soy-treated women, Ki-67 labeling index increased from 1.71 to 2.18 (P = 0.04). We saw no treatment effect on cytologic atypia or NAF parameters. There were significant increases in the expression of 14 of 28 genes within the soy, but not the control group, without significant between-group differences. Plasma genistein values showed excellent compliance. A 6-month intervention of mixed soy isoflavones in healthy, high-risk adult Western women did not reduce breast epithelial proliferation, suggesting a lack of efficacy for breast cancer prevention and a possible adverse effect in premenopausal women.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.