NCT01926964

Adjuvant Treatment Recommendation and Oncotype DX® in Early Breast Cancer

Impact of Recurrence Score® on Recommendations for Adjuvant Treatment in Patients With ER-positive Breast Cancer

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 229 (actual)
• Sponsor: Swiss Cancer Institute · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Breast Cancer

Timeline

• Start date: 2013-09-01
• Primary completion: 2015-01-01
• Completion: 2015-02-01
• First posted: 2013-08-21
• Last updated: 2019-05-15

Locations

19 sites across 1 country: Switzerland