Ignite Creation Date:
2024-05-06 @ 3:01 AM
Last Modification Date:
2024-10-26 @ 11:27 AM
Study NCT ID:
NCT02187991
Status:
COMPLETED
Last Update Posted:
2023-08-14
First Post:
2014-07-06
Brief Title:
Study to Compare Alisertib With Paclitaxel vs Paclitaxel Alone in Metastatic or Locally Recurrent Breast Cancer
Sponsor:
US Oncology Research
Organization:
US Oncology Research
Study Overview
Official Title:
A Phase II Multicenter Randomized Parallel Group Study to Compare Alisertib in Combination With Paclitaxel vs Paclitaxel Alone in Patients With Metastatic or Locally Recurrent Breast Cancer
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical research study is to learn if the study drug alisertib MLN8237 in combination with chemotherapy paclitaxel can shrink or slow tumor growth in women with hormone receptor HR-positive human epidermal growth factor receptor 2 HER2-negative or HR-negative HER2-negative triple negative locally recurrent or metastatic breast cancer MBC The safety of alisertib in combination with paclitaxel will also be studied The physical state of the patient symptoms changes in the size of the tumor and laboratory findings obtained while on-study will help the research team decide if alisertib plus paclitaxel is safe and effective in patients with this type of breast cancer
Alisertib belongs to a group of drugs called Aurora kinase inhibitors Alisertib blocks the activity of Aurora A kinase a protein that is involved in tumor cell multiplication and survival Aurora A kinase is expressed at higher than normal levels in many types of cancer including breast cancer and preclinical studies suggest that blocking the activity of this protein can lead to the death of cancer cells
Paclitaxel is a chemotherapy drug commonly used to treat many different kinds of cancer including metastatic breast cancer The reason to combine alisertib and paclitaxel is that in cancer therapy combinations of drugs are often more effective as a treatment than either of the same drugs used alone
Alisertib belongs to a group of drugs called Aurora kinase inhibitors Alisertib blocks the activity of Aurora A kinase a protein that is involved in tumor cell multiplication and survival Aurora A kinase is expressed at higher than normal levels in many types of cancer including breast cancer and preclinical studies suggest that blocking the activity of this protein can lead to the death of cancer cells
Paclitaxel is a chemotherapy drug commonly used to treat many different kinds of cancer including metastatic breast cancer The reason to combine alisertib and paclitaxel is that in cancer therapy combinations of drugs are often more effective as a treatment than either of the same drugs used alone
Detailed Description:
The rationale behind assessing the effectiveness of the addition of alisertib to weekly paclitaxel therapy in patients with Triple Negative Breast Cancer and highly proliferative estrogen receptor-positive ER and HER2- breast cancer is based on the unmet clinical need for effective strategies to prevent or delay resistance to taxane therapy in the metastatic setting Synergistic or additive effects have been observed in breast cancer xenograft models which involved alisertib added to either paclitaxel or docetaxel Alisertib inhibited the Pgp-mediated efflux of paclitaxel in a cell culture model In addition Aurora Kinase A is frequently overexpressed in Triple Negative Breast Cancer TNBC and expression levels have been shown to be prognostic in both of these breast cancer subtypes The combination of alisertib with paclitaxel has also been investigated in a Phase 1 study in patients with locally advanced or metastatic ovarian and breast cancers with preliminary evidence of activity in both tumor types including 6 partial response PRs and 3 stable disease SD in 11 patients with metastatic breast cancer
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None