Skip to main content
  • AACR Publications
    • Cancer Discovery
    • Cancer Epidemiology, Biomarkers & Prevention
    • Cancer Immunology Research
    • Cancer Prevention Research
    • Cancer Research
    • Clinical Cancer Research
    • Molecular Cancer Research
    • Molecular Cancer Therapeutics

  • Register
  • Log in
Advertisement

Main menu

  • Home
  • About
    • The Journal
    • AACR Journals
    • Subscriptions
    • Permissions and Reprints
    • Reviewing
  • Articles
    • OnlineFirst
    • Current Issue
    • Past Issues
    • Focus on Computer Resources
    • 75th Anniversary
    • Meeting Abstracts
  • For Authors
    • Information for Authors
    • Author Services
    • Best of: Author Profiles
    • Submit
  • Alerts
    • Table of Contents
    • OnlineFirst
    • Editors' Picks
    • Citations
    • Author/Keyword
  • News
    • Cancer Discovery News
  • AACR Publications
    • Cancer Discovery
    • Cancer Epidemiology, Biomarkers & Prevention
    • Cancer Immunology Research
    • Cancer Prevention Research
    • Cancer Research
    • Clinical Cancer Research
    • Molecular Cancer Research
    • Molecular Cancer Therapeutics

User menu

  • Register
  • Log in

Search

  • Advanced search
Cancer Research
Cancer Research

Advanced Search

  • Home
  • About
    • The Journal
    • AACR Journals
    • Subscriptions
    • Permissions and Reprints
    • Reviewing
  • Articles
    • OnlineFirst
    • Current Issue
    • Past Issues
    • Focus on Computer Resources
    • 75th Anniversary
    • Meeting Abstracts
  • For Authors
    • Information for Authors
    • Author Services
    • Best of: Author Profiles
    • Submit
  • Alerts
    • Table of Contents
    • OnlineFirst
    • Editors' Picks
    • Citations
    • Author/Keyword
  • News
    • Cancer Discovery News
Ongoing Clinical Trials

Abstract OT3-06-01: KARISMA, The karma intervention study. - A tamoxifen dose determination trial

S Borgquist, M Eriksson, K Czene and P Hall
S Borgquist
Lund University, Lund, Sweden; Karolinska Institutet, Stockholm, Sweden
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
M Eriksson
Lund University, Lund, Sweden; Karolinska Institutet, Stockholm, Sweden
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
K Czene
Lund University, Lund, Sweden; Karolinska Institutet, Stockholm, Sweden
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
P Hall
Lund University, Lund, Sweden; Karolinska Institutet, Stockholm, Sweden
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
DOI: 10.1158/1538-7445.SABCS16-OT3-06-01 Published February 2017
  • Article
  • Info & Metrics
Loading
Abstracts: 2016 San Antonio Breast Cancer Symposium; December 6-10, 2016; San Antonio, Texas

Abstract

Background: Breast cancer incidence is increasing throughout the world. Despite remarkable risk reducing effects demonstrated in preventive randomised endocrine trials; primary preventive strategies are scarcely part of clinical routine. Putative reasons for reluctance may be inadequate tools for identification of women at high risk of breast cancer and reluctance to prescribe pharmaceuticals with considerable side effects in the preventive setting.

Trial Design: A randomized, double blinded, six-armed placebo controlled dose determination study to investigate the optimal dose of tamoxifen with the most favorable side effect spectra. To reduce the number of participants, costs and to shorten the trial period; change in mammographic density will be used as clinical outcome. After randomization and baseline mammography, women will be treated with placebo, 1mg, 2.5mg, 5mg, 10mg or 20mg of tamoxifen for six months where after a subsequent mammogram is performed.

Eligibility criteria: 1) Attending the national Swedish mammography screening program, 2) Having a measurable mammographic density, i.e. ≥4.5 % density (volumetric) measured by Volpara.

Specific aims: The primary aim is to identify the minimum dose of tamoxifen non-inferior in its ability to reduce mammographic density and with fewer side effects compared to 20 mg of tamoxifen. Secondarily, to study the associations between different doses of tamoxifen and changes in circulating levels of a number of proteins, lipids, hormones, and tamoxifen metabolites, including the impact of polymorphisms in the CYP2D6 gene. A translational aim is to study molecular changes in the healthy breast tissue as a result of tamoxifen exposure.

Statistical Methods: Previous studies have shown that ∼ 50% of women treated with 20mg of tamoxifen have a reduction in density and respond to therapy. We therefore use the median density decrease in women treated with 20mg tamoxifen as the predefined response threshold. The primary efficacy endpoint is thus the proportion of responders that reaches this threshold. We will test for non-inferiority after treatment with placebo, 1mg, 2.5mg, 5mg, and 10mg compared to the group of women treated with 20mg tamoxifen. Per definition 50% of the women in the 20mg group are responders. The non-inferiority margin is defined to be 16.7 percentage points; that is the fraction of responders is not less than one third of the treated individuals (50% minus 16.7% = 33.3%).The null hypothesis is thus that the proportion of responders in women treated with placebo, 1mg, 2.5mg, 5mg, and 10mg is 33.3% or higher. Power calculations have determined a need of 1200 participants corresponding to 200 participants in each treatment arm.

Present accrual and target accrual: The trial will start recruiting as of September 2016. Eligible women are identified from the Swedish mammographic screening cohort, i.e. women age 40-74 years invited for biennial screening.

Contact information for people with a specific interest in the trial:

Signe.Borgquist@med.lu.se & Per.Hall@ki.se.

Citation Format: Borgquist S, Eriksson M, Czene K, Hall P. KARISMA, The karma intervention study. - A tamoxifen dose determination trial [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr OT3-06-01.

Previous
Back to top
Cancer Research: 77 (4 Supplement)
February 2017
Volume 77, Issue 4 Supplement
  • Table of Contents
  • Index by Author

Sign up for alerts

Article Alerts
Sign In to Email Alerts with your Email Address
Email Article

Thank you for sharing this Cancer Research article.

NOTE: We request your email address only to inform the recipient that it was you who recommended this article, and that it is not junk mail. We do not retain these email addresses.

Enter multiple addresses on separate lines or separate them with commas.
Abstract OT3-06-01: KARISMA, The karma intervention study. - A tamoxifen dose determination trial
(Your Name) has forwarded a page to you from Cancer Research
(Your Name) thought you would be interested in this article in Cancer Research.
Citation Tools
Abstract OT3-06-01: KARISMA, The karma intervention study. - A tamoxifen dose determination trial
S Borgquist, M Eriksson, K Czene and P Hall
Cancer Res February 15 2017 (77) (4 Supplement) OT3-06-01; DOI: 10.1158/1538-7445.SABCS16-OT3-06-01

Citation Manager Formats

  • BibTeX
  • Bookends
  • EasyBib
  • EndNote (tagged)
  • EndNote 8 (xml)
  • Medlars
  • Mendeley
  • Papers
  • RefWorks Tagged
  • Ref Manager
  • RIS
  • Zotero
Share
Abstract OT3-06-01: KARISMA, The karma intervention study. - A tamoxifen dose determination trial
S Borgquist, M Eriksson, K Czene and P Hall
Cancer Res February 15 2017 (77) (4 Supplement) OT3-06-01; DOI: 10.1158/1538-7445.SABCS16-OT3-06-01
del.icio.us logo Digg logo Reddit logo Twitter logo CiteULike logo Facebook logo Google logo Mendeley logo
  • Tweet Widget
  • Facebook Like
  • Google Plus One

Jump to section

  • Article
  • Info & Metrics
Advertisement

Related Articles

Cited By...

More in this TOC Section

Ongoing Clinical Trials

  • Abstract OT3-05-01: TBCRC 039: Phase II study of combination ruxolitinib (INCB018424) with preoperative chemotherapy for triple negative inflammatory breast cancer
  • Abstract OT3-06-02: A phase Ib trial of xentuzumab and abemaciclib in patients with locally advanced or metastatic solid tumors, including hormone receptor-positive, HER2-negative breast cancer (plus endocrine therapy)
  • Abstract OT2-07-08: Substantially improving the cure rate of high-risk BRCA1-like breast cancer patients with personalized therapy (SUBITO) - an international randomized phase III trial
Show more 3

Prevention

  • Abstract OT3-01-02: Randomized controlled trial of web-based decision support tools for high-risk women and primary care providers to increase breast cancer chemoprevention
  • Abstract OT3-01-01: Chemoprevention in BRCA1 mutation carriers (CIBRAC): A proof of concept clinical trial
  • Abstract B22: Selective responses of HepG2 cancer cells and primary hepatocytes to growth regulatory effects of Fe (II) and herbal tea flavonoids
Show more 3
  • Home
  • Alerts
  • Feedback
Facebook  Twitter  LinkedIn  YouTube  RSS

Articles

  • Online First
  • Current Issue
  • Past Issues
  • Meeting Abstracts

Info for

  • Authors
  • Subscribers
  • Advertisers
  • Librarians
  • Reviewers

About Cancer Research

  • About the Journal
  • Editorial Board
  • Permissions
  • Submit a Manuscript
AACR logo

Copyright © 2018 by the American Association for Cancer Research.

Cancer Research Online ISSN: 1538-7445
Cancer Research Print ISSN: 0008-5472
Journal of Cancer Research ISSN: 0099-7013
American Journal of Cancer ISSN: 0099-7374

Advertisement