Breast Cancer Clinical Trial
Official title:
Measuring the Impact of MammaPrint on Adjuvant and Neoadjuvant Treatment in Breast Cancer Patients: A Prospective Registry
The scope of this study is to measure the impact of MammaPrint on treatment in Hormone
Receptor (HR)-positive HER2-negative breast cancer patients.
In addition, the impact of MammaPrint on treatment in patients with T1a/T1b and pN0/pN1 (up
to 1 node), Triple Negative or HER2-positive tumors will be assessed.
Eligible patients will have their tumor sample analyzed for MammaPrint, BluePrint and
TargetPrint. Patients cannot start treatment before the MammaPrint and BluePrint result is
received and taken into consideration for the treatment plan. The clinical data are to be
entered online. There will be 2 Case Report Forms (CRFs). Baseline clinical data and
physician chemotherapy intention before knowing the MammaPrint and BluePrint result will be
entered in CRF 1. After completion of CRF1, the MammaPrint and BluePrint result will be
released. CRF2 will be completed after the final treatment decision has been made. This CRF
will capture physician chemotherapy intention after the MammaPrint and BluePrint result and
the impact of these results.
A sample size of 331 patients is required to detect a 25% overall treatment change (5%
significance and 95% power) in stage I and II HR-positive, HER2-negative patients receiving
adjuvant therapy.
In addition at least 50 T1a/bN0/1 (up to 1 node) Triple Negative, at least 50 T1a/bN0/1 (up
to 1 node) HER2-positive breast cancer patients, and at least 50 patients receiving
neoadjuvant therapy will be enrolled.
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