Case-Control-Study on the Breast Cancer Risk of Mirena® Compared With Copper IUDs

Study Overview
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Brief Summary
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The objective of this study is to determine the breast cancer risk of Mirena® users compared to copper intrauterine device (IUD) users in a community-based case-control study.

Detailed Description
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This is a community-based case-control study in Germany and Finland. Cases will be identified from cancer registries, tumor centers and breast centers. Matched controls will be accrued from the same region as the case came from. Breast cancer cases and their controls are women under 50 years of age without known history of malignancies. Cases are women with a breast cancer who are younger than 50 years of age at cancer diagnosis. The breast cancer was diagnosed between January 2000 and December 2007. Only alive cases and cases in a sufficiently good health status to be interviewed are eligible for the study. Controls are women without a breast cancer diagnosis who are younger than 50 years of age at the time of the interview. About 3 controls matched by year of birth and region will be allocated to each case. A standardized questionnaire will be used for all breast cancer cases and controls. The questionnaire will be mailed to cases and controls. Study participants will be asked for their informed consent. Data confidentiality according to national laws will be ensured by the field organizations.

Official Title
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Case-Control-Study on the Breast Cancer Risk of Mirena® Compared With Copper IUDs

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: Levonorgestrel-releasing IUD
* Device: Copper IUD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: cases: women with a breast cancer who are younger than 50 years of age at cancer diagnosis controls: women without a breast cancer diagnosis who are younger than 50 years at the time of the interview Exclusion Criteria: women who are not willing to participate

Ages Eligible for Study
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Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Breast Cancer Cases | Device: Levonorgestrel-releasing IUD<br>* This is a case-control-study; strictly speaking the category intervention type does not apply to this study.<br>* Other names: Mirena;Device: Copper IUD<br>* This is a case-control-study; strictly speaking the category intervention type does not apply to this study.<br>|
| 2<br>Matched Controls for Breast Cancer Cases | Device: Levonorgestrel-releasing IUD<br>* This is a case-control-study; strictly speaking the category intervention type does not apply to this study.<br>* Other names: Mirena;Device: Copper IUD<br>* This is a case-control-study; strictly speaking the category intervention type does not apply to this study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breast Cancer Risk | Breast cancer (invasive carcinoma or carcinoma in situ) in women aged <50 years at diagnosis. Cases were excluded if they had died before study start or had a history of malignancy. | retrospective, January 2000 to December 2007 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer