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| Name | Class |
|---|---|
| Cedar Associates LLC | OTHER |
| Illumina, Inc. | INDUSTRY |
| Grupo Espanol de Investigacion del Cancer de Mama | OTHER |
| Spanish Breast Cancer Research Group |
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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 Prosigna 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 females, which is 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 |
|---|---|---|
| Miguel Martin, M.D., Ph.D. | Hospital General Universitario Gregorio Marañón | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Consorci Sanitari de Terrassa | Barcelona | Spain | ||||
| Corporacio Sanitaria Parc Tauli |
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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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| OTHER |
| Hospital General Universitario Gregorio Marañon | OTHER |
| Vall d'Hebron Institute of Oncology | OTHER |
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FFPE breast tumor tissue samples
| Barcelona |
| Spain |
| Hospital U. Vall D'Hebron | Barcelona | Spain |
| Hospital U. Arnau de Vilanova | Lleida | Spain |
| Hospital G.U. Gregorio Maranon | Madrid | Spain |
| Hospital Quirón Madrid | Madrid | Spain |
| Hospital U. 12 de Octubre | Madrid | Spain |
| D017437 |
| Skin and Connective Tissue Diseases |