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The primary objective of this study is to assess the extent to which the Prosigna™ Breast Cancer Prognostic Gene Signature Assay affects the medical oncologist's treatment recommendations regarding adjuvant chemotherapy and actual treatments received for patients with early-stage breast cancer.
Changes in treatment recommendations will include (1) hormonal therapy alone, (2) hormonal therapy plus chemotherapy, and (3) changes in types of chemotherapy if chemotherapy was recommended before and after the test.
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| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients whose choice of treatment is changed as a result of receiving the Prosigna test result. | 6 months |
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Inclusion Criteria:
Resected node-negative, estrogen-receptor-positive, HER2-negative early- stage invasive breast cancer (T1-T2, N0, pN0 (i+), pN0 (mol+), M0)
Postmenopausal women defined as:
Able to give consent
Eligible for treatment of breast cancer with adjuvant chemotherapy
ECOG performance status of 0 or 1
Exclusion Criteria:
Tumor size T3-T4
Non-invasive breast cancer (e.g., Paget's disease, DCIS)
Tumors with nodes that are not N0, pN0 (i+), or pN0 (mol+)
Tumors that are estrogen-receptor negative or HER2 positive
Have metastatic disease
Unable to give informed consent
Unable to complete patient reported outcome surveys
Have contraindications for adjuvant chemotherapy
ECOG performance status > 1
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Postmenopausal women with node-negative, estrogen-receptor positive, HER2-negative early-stage breast cancer. Investigators will offer enrollment to consecutively seen women who meet the entry criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Nadia Harbeck, MD, PhD | Leitung des Brustzentrums der Universität München | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Kiel | Kiel | 24105 | Germany | |||
| Universitätsfrauenklinik Ulm |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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FFPE samples from breast tumor tissue
| Ulm |
| 89081 |
| Germany |
| D017437 |
| Skin and Connective Tissue Diseases |