Adjuvant Treatment Recommendation and Oncotype DX® in Early Breast Cancer
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|ClinicalTrials.gov Identifier: NCT01926964|
Recruitment Status : Completed
First Posted : August 21, 2013
Last Update Posted : May 15, 2019
Oncotype DX® is likely to become more widely used in Europe as well as in Switzerland. The test is currently not reimbursed by the Swiss health insurances.
The proposed study will investigate to what extent adjuvant treatment recommendations in breast cancer patients with an ER-positive tumor, made by Swiss tumor boards, are based on conventional factors, and whether the recommendations would change, when RS results from the Oncotype DX® test were available.
In addition this study approaches the dilemma of adding adjuvant CT to adjuvant endocrine therapy in a systematic fashion. In this study, the St. Gallen consensus 2009 (with a minor update from the 2011 consensus, is used to predefine the patients suitable for endocrine therapy or chemo-endocrine therapy. Once results of this study are available they may help to better integrate Oncotype DX® with other factors. Currently, it is unclear how the different factors should be integrated into one recommendation.
This study will provide data on the usefulness of this test for the two patient groups which are suitable for hormone therapy only and for those who are considered for hormone plus chemotherapy.
|Condition or disease|
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||229 participants|
|Target Follow-Up Duration:||3 Weeks|
|Official Title:||Impact of Recurrence Score® on Recommendations for Adjuvant Treatment in Patients With ER-positive Breast Cancer|
|Study Start Date :||September 2013|
|Actual Primary Completion Date :||January 2015|
|Actual Study Completion Date :||February 2015|
Early breast cancer patients
Patients with ER-positive, HER2 negative, pN0 or pN1a and resected primary breast cancer R0 resection.
- The decision change between the first and second tumor board adjuvant treatment recommendation [ Time Frame: 1 month ]
- The decision change between first and second shared decision about adjuvant treatment [ Time Frame: 3 weeks ]
- The decision change between first shared decision and treatment actually given [ Time Frame: Between 1 and 3 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01926964
|Study Chair:||Bernhard Pestalozzi, Prof||University Hospital, Zürich|
|Study Chair:||Stefan Aebi, Prof.||Luzerner Kantonsspital|