Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2014
A randomized phase II presurgical trial of transdermal 4-hydroxytamoxifen gel versus oral tamoxifen in women with ductal carcinoma in situ of the breast.
Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02936999 (An Exploratory Pilot Study of Vitamin D Supplementation in Women With DCIS and/or LCIS), which is not on this map. Cited by 34 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.
An Exploratory Pilot Study of Vitamin D Supplementation in Women With DCIS and/or LCIS
Who cites it
34 citing papers in PubMed, 1 synthesis or guideline pooled it, 86 citations in OpenAlex.
- Quality of life issues in patients with ductal carcinoma in situ: a systematic review.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2024Pooled it
- Local Transdermal Delivery of Telapristone Acetate Through Breast Skin, Compared With Oral Treatment: A Randomized Double-Blind, Placebo-Controlled Phase II Trial.Clinical pharmacology and therapeutics · 2021Trial
- Review
- Sustained-release of 4-hydroxytamoxifen inhibits capsular contracture after breast implant placement in a mouse model.Breast cancer (Tokyo, Japan) · 2025Article
- Window-of-opportunity trials to screen effective agents and optimize dose in breast cancer prevention.NPJ breast cancer · 2025Review
- Characterizing safety, toxicity, and breast cancer risk reduction using a long-term fulvestrant eluting implant.Scientific reports · 2025Article
- A Comprehensive Review on Current Knowledge and Future Potential of Topical Therapies in Breast Cancer Treatment.European journal of breast health · 2025Article
- Update in the clinical utilization of chemoprevention for breast cancer: a narrative review.Frontiers in oncology · 2025Review
- Transcriptomics analysis reveals molecular alterations underpinning spaceflight dermatology.Communications medicine · 2024Article
- Review
- Current status and challenges of breast cancer prevention~DNA methylation would lead to groundbreaking progress in breast cancer prevention~.Genes and environment : the official journal of the Japanese Environmental Mutagen Society · 2023Review
- A long-term fulvestrant eluting implant is safe, non-toxic, and reduces the risk of breast cancer in in vivo models.Research square · 2023Article
- Non-systemic Approaches for Ductal Carcinoma In Situ: Exploring the Potential of Ultra-flexible Combisomes as a Novel Drug Delivery Strategy-a Review.AAPS PharmSciTech · 2023Review
- Short-term changes in ultrasound tomography measures of breast density and treatment-associated endocrine symptoms after tamoxifen therapy.NPJ breast cancer · 2023Article
- Phase I Dose Escalation Study of Topical Bexarotene in Women at High Risk for Breast Cancer.Cancer prevention research (Philadelphia, Pa.) · 2023Article
- Targeting nuclear hormone receptors for the prevention of breast cancer.Frontiers in medicine · 2023Review
- Transdermal Delivery of Chemotherapeutics: Strategies, Requirements, and Opportunities.Pharmaceutics · 2021Review
- Efficacy of Emu Oil Transfersomes for Local Transdermal Delivery of 4-OH Tamoxifen in the Treatment of Breast Cancer.Pharmaceutics · 2020Article
- Tamoxifen inhibits cell proliferation by impaired glucose metabolism in gallbladder cancer.Journal of cellular and molecular medicine · 2020Article
- Cancer Chemoprevention: Preclinical In Vivo Alternate Dosing Strategies to Reduce Drug Toxicities.Toxicological sciences : an official journal of the Society of Toxicology · 2019Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
22 authors at 6 institutions in 3 countries.
Funding
Abstract
purposeLocal transdermal therapy to the breast may achieve effective target-organ drug delivery, while diminishing systemic effects. We conducted a randomized, double-blind, placebo-controlled phase II trial comparing transdermal 4-hydroxytamoxifen gel (4-OHT) to oral tamoxifen (oral-T) in women with ductal carcinoma in situ (DCIS).
methodsTwenty-seven pre- and postmenopausal women were randomized to 4-OHT (4 mg/day) or oral-T (20 mg/day) for 6 to 10 weeks before surgery. Plasma, nipple aspirate fluid, and breast adipose tissue concentrations of tamoxifen and its major metabolites were determined by liquid chromatography/tandem mass spectrometry. The primary endpoint was Ki67 labeling in DCIS lesions, measured by immunohistochemistry. In plasma, insulin-like growth factor-1 (IGFI), sex hormone-binding globulin (SHBG), and coagulation protein concentrations were determined.
resultsPosttherapy Ki67 decreased by 3.4% in the 4-OHT and 5.1% in the oral-T group (P ≤ 0.03 in both, between-group P = 0. 99). Mean plasma 4-OHT was 0.2 and 1.1 ng/mL in 4-OHT and oral groups, respectively (P = 0.0003), whereas mean breast adipose tissue concentrations of 4-OHT were 5.8 ng/g in the 4-OHT group and 5.4 ng/g in the oral group (P = 0.88). There were significant increases in plasma SHBG, factor VIII, and von Willebrand factor and a significant decrease in plasma IGFI with oral-T, but not with 4-OHT. The incidence of hot flashes was similar in both groups.
conclusionsThe antiproliferative effect of 4-OHT gel applied to breast skin was similar to that of oral-T, but effects on endocrine and coagulation parameters were reduced. These findings support the further evaluation of local transdermal therapy for DCIS and breast cancer prevention.
Indexed as
Identifiers
What OpenQuestion 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 OpenQuestion graph.