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Association details:
| Biomarker: | HER-2 negative |
|---|---|
| Cancer: | HER2 Negative Breast Cancer |
| Drug: | alisertib (MLN8237) (Aurora kinase A inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Alisertib With or Without Fulvestrant in Treating Patients With Locally Advanced or Metastatic, Endocrine-Resistant Breast Cancer
Excerpt:
...- History of ER positive (+) (>= 10% of cells positive on hematoxylin and eosin stain [H&E]), HER2 negative (-) breast cancer disease, either as a...
Trial ID:
Source:
Title:
Study to Compare Alisertib With Paclitaxel vs. Paclitaxel Alone in Metastatic or Locally Recurrent Breast Cancer
Excerpt:
...- HER2 negative status (based on most recently analyzed biopsy) is defined as immunohistochemistry (IHC) status of 0, 1+ or 2+ (if IHC 2+, a negative FISH test is required, i.e., HER2 fluorescence in situ hybridization (FISH) ratio < 2.0 with an average HER2 copy number <4.0 signals/cell); ER-negative and PR-negative status is defined as ER and PgR <1% nuclei positive by IHC...
Trial ID:
Less C2 evidence
Source:
Title:
Efficacy and Safety of Weekly Paclitaxel With or Without Oral Alisertib in Patients With Metastatic Breast Cancer: A Randomized Clinical Trial
Published date:
04/01/2021
Excerpt:
To compare paclitaxel alone vs paclitaxel plus alisertib in patients with ER-positive and ERBB2-negative or triple-negative metastatic breast cancer (MBC)....This randomized clinical trial found that the addition of oral alisertib to a reduced dose of weekly paclitaxel significantly improved PFS compared with paclitaxel alone...
Secondary therapy:
paclitaxel
DOI:
10.1001/jamanetworkopen.2021.4103
Trial ID:
