Ignite Creation Date:
2024-05-06 @ 3:08 AM
Last Modification Date:
2024-10-26 @ 11:29 AM
Study NCT ID:
NCT02219789
Status:
COMPLETED
Last Update Posted:
2018-10-03
First Post:
2014-08-15
Brief Title:
Alisertib and Fulvestrant in Treating Patients With Hormone Receptor Positive Breast Cancer That is Metastatic or Locally Advanced and Cannot Be Removed by Surgery
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
A Phase I Trial to Evaluate the Safety of the Addition of Alisertib to Fulvestrant in Women With Advanced Hormone Receptor Positive HR Breast Cancer
Status:
COMPLETED
Status Verified Date:
2018-10
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:
This phase I trial studies the side effects and best dose of alisertib when given together with fulvestrant in treating patients with hormone positive breast cancer that has spread to other parts of the body or has spread from where it started to nearby tissue or lymph nodes and cannot be removed by surgery Alisertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Estrogen and progesterone are type of hormones made by the body and they can cause the growth of breast cancer cells Hormone therapy using fulvestrant may fight breast cancer by lowering the amount of estrogen or progesterone the body makes Giving alisertib together with fulvestrant may be a better treatment for breast cancer
Detailed Description:
PRIMARY OBJECTIVES
I To determine the maximally tolerated dose of alisertib in combination with fulvestrant
SECONDARY OBJECTIVES
I To describe the safety and tolerability of alisertib in combination with fulvestrant
II To examine tumor response in postmenopausal women treated with alisertib in combination with fulvestrant
TERTIARY OBJECTIVES
I To assess aurora A kinase expression in archived breast cancer tissue biospecimens of participants and to describe levels in those who do or do not experience dose-limiting toxicities DLTs or objective response
OUTLINE This is a dose-escalation study of alisertib
Patients receive fulvestrant intramuscularly IM on day 1 days 1 and 15 of course 1 only and alisertib orally PO twice daily BID on days 1-3 8-10 and 15-17 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up at 1 month
I To determine the maximally tolerated dose of alisertib in combination with fulvestrant
SECONDARY OBJECTIVES
I To describe the safety and tolerability of alisertib in combination with fulvestrant
II To examine tumor response in postmenopausal women treated with alisertib in combination with fulvestrant
TERTIARY OBJECTIVES
I To assess aurora A kinase expression in archived breast cancer tissue biospecimens of participants and to describe levels in those who do or do not experience dose-limiting toxicities DLTs or objective response
OUTLINE This is a dose-escalation study of alisertib
Patients receive fulvestrant intramuscularly IM on day 1 days 1 and 15 of course 1 only and alisertib orally PO twice daily BID on days 1-3 8-10 and 15-17 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up at 1 month
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P30CA015083 | NIH | Mayo Clinic | httpsreporternihgovquickSearchP30CA015083 |
| NCI-2014-01726 | REGISTRY | None | None |
| MC1231 | OTHER | None | None |