Trial reportBMC cancer2016
Phase II study of metformin for reduction of obesity-associated breast cancer risk: a randomized controlled trial protocol.
Trial report in BMC cancer, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02028221 (Phase II Study of Metformin for Reduction of Obesity-Associated Breast Cancer Risk), which is not on this map. Cited by 21 papers, 1 of them a synthesis 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.
Phase II Study of Metformin for Reduction of Obesity-Associated Breast Cancer Risk
Who cites it
21 citing papers in PubMed, 1 synthesis or guideline pooled it, 39 citations in OpenAlex.
- Mechanisms underlying obesity-malignancy connection: a systematic narrative review.Journal of physiology and biochemistry · 2025Pooled it
- A randomized controlled trial of metformin in women with components of metabolic syndrome: intervention feasibility and effects on adiposity and breast density.Breast cancer research and treatment · 2021Trial
- Metformin and its Nanoformulations in Cancer Prevention and Therapy.Current pharmaceutical design · 2025Review
- Article
- Drug repurposing for cancer therapy.Signal transduction and targeted therapy · 2024Review
- Metformin and Breast Cancer: Current Findings and Future Perspectives from Preclinical and Clinical Studies.Pharmaceuticals (Basel, Switzerland) · 2024Review
- Combination of metformin and gallic acid induces autophagy and apoptosis in human breast cancer cells.Research in pharmaceutical sciences · 2023Article
- Association between diabetes status and breast cancer in US adults: findings from the US National Health and Nutrition Examination Survey.Frontiers in endocrinology · 2023Article
- The promising therapeutic effects of metformin on metabolic reprogramming of cancer-associated fibroblasts in solid tumors.Cellular & molecular biology letters · 2022Article
- Obesity and Breast Cancer Risk: The Oncogenic Implications of Metabolic Dysregulation.The Journal of clinical endocrinology and metabolism · 2022Article
- Cardiovascular disease in type 2 diabetes mellitus: progress toward personalized management.Cardiovascular diabetology · 2022Review
- Nipple Aspirate Fluid at a Glance.Cancers · 2021Review
- In Situ Metabolic Characterisation of Breast Cancer and Its Potential Impact on Therapy.Cancers · 2020Article
- Metformin and Chemoprevention: Potential for Heart-Healthy Targeting of Biologically Aggressive Breast Cancer.Frontiers in public health · 2020Review
- Molecular Links between Central Obesity and Breast Cancer.International journal of molecular sciences · 2019Review
- Challenges and future of precision medicine strategies for breast cancer based on a database on drug reactions.Bioscience reports · 2019Review
- Combination of Oligofructose and Metformin Alters the Gut Microbiota and Improves Metabolic Profiles, Contributing to the Potentiated Therapeutic Effects on Diet-Induced Obese Animals.Frontiers in endocrinology · 2019Article
- Assessment of mammographic breast density after sleeve gastrectomy.Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery · 2018Article
- Obesity, Metabolic Syndrome, and Breast Cancer: From Prevention to Intervention.Current surgery reports · 2018Article
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 3 institutions in 1 country.
Funding
Abstract
backgroundTwo-thirds of U.S. adult women are overweight or obese. High body mass index (BMI) and adult weight gain are risk factors for a number of chronic diseases, including postmenopausal breast cancer. The higher postmenopausal breast cancer risk in women with elevated BMI is likely to be attributable to related metabolic disturbances including altered circulating sex steroid hormones and adipokines, elevated pro-inflammatory cytokines, and insulin resistance. Metformin is a widely used antidiabetic drug that has demonstrated favorable effects on metabolic disturbances and as such may lead to lower breast cancer risk in obese women. Further, the anti-proliferative effects of metformin suggest it may decrease breast density, an accepted biomarker of breast cancer risk. METHODS/
designThis is a Phase II randomized, double-blind, placebo-controlled trial of metformin in overweight/obese premenopausal women who have elements of metabolic syndrome. Eligible participants will be randomized to receive metformin 850 mg BID (n = 75) or placebo (n = 75) for 12 months. The primary endpoint is change in breast density, based on magnetic resonance imaging (MRI) acquired fat-water features. Secondary outcomes include changes in serum insulin levels, serum insulin-like growth factor (IGF)-1 to insulin-like growth factor binding protein (IGFBP)-3 ratio, serum IGF-2 levels, serum testosterone levels, serum leptin to adiponectin ratio, body weight, and waist circumference. Exploratory outcomes include changes in metabolomic profiles in plasma and nipple aspirate fluid. Changes in tissue architecture as well as cellular and molecular targets in breast tissue collected in a subgroup of participants will also be explored. DISCUSSION: The study will evaluate whether metformin can result in favorable changes in breast density, select proteins and hormones, products of body metabolism, and body weight and composition. The study should help determine the potential breast cancer preventive activity of metformin in a growing population at risk for multiple diseases.
trial registrationClinicalTrials.gov Identifier: NCT02028221 . Registered on January 2, 2014. Grant #: 1R01CA172444-01A1 awarded on Sept 11, 2013.
Indexed as
Identifiers
What Socratic holds
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 Socratic graph.