Ignite Creation Date:
2024-05-06 @ 2:59 PM
Last Modification Date:
2024-10-26 @ 1:40 PM
Study NCT ID:
NCT04481113
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-07
First Post:
2020-07-17
Brief Title:
Abemaciclib and Niraparib Before Surgery for the Treatment of Hormone Receptor Positive HER2 Negative Breast Cancer
Sponsor:
OHSU Knight Cancer Institute
Organization:
OHSU Knight Cancer Institute
Study Overview
Official Title:
A Phase 1 Study of Abemaciclib and Niraparib As Neoadjuvant Therapy in Hormone Receptor Positive HR HER2 Negative HER2- Breast Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase I trial tests the side effects and best dose of abemaciclib and niraparib in treating patients with breast cancer that is positive for estrogen or progesterone receptors hormone receptor positive HR and HER2 negative Abemaciclib may stop the growth of tumor cells by blocking certain proteins called cyclin-dependent kinases which are needed for cell growth PARPs are proteins that help repair DNA mutations PARP inhibitors such as niraparib can keep PARP from working so tumor cells cant repair themselves and grow Giving abemaciclib and niraparib together before surgery may make the tumor smaller
Detailed Description:
PRIMARY OBJECTIVES
I To determine the maximum-tolerated dose MTD andor recommended phase 2 dose of the combination of abemaciclib and niraparib tosylate monohydrate niraparib
II To assess safety and tolerability of the combination of abemaciclib and niraparib in early stage HR breast cancer
SECONDARY OBJECTIVES
I To determine clinical response to treatment II To determine pathologic response to treatment III To determine feasibility of combination as determined by no delay to standard of care breast surgery
EXPLORATORY OBJECTIVE
I To assess occurrence of secondary myelodysplastic syndrome MDSacute myeloid leukemia AML malignancy
OUTLINE This is a phase 1 dose-escalation study of abemaciclib in combination with niraparib followed by a dose-expansion study
Patients receive abemaciclib orally PO twice daily BID and niraparib PO once daily QD Treatment repeats every 28 days for up to 2-4 cycles in the absence of disease progression or unacceptable toxicity Patients who complete 4 cycles undergo standard of care mastectomy or lumpectomy Patients demonstrating progressive disease after only 2 cycles are switched to receive standard of care chemotherapy prior to undergoing mastectomy or lumpectomy
Patients are followed up at 30 days after date of surgery every 3 months for the first 6 months every 6 months for 2 years then annually for up to 5 years from date of surgery
I To determine the maximum-tolerated dose MTD andor recommended phase 2 dose of the combination of abemaciclib and niraparib tosylate monohydrate niraparib
II To assess safety and tolerability of the combination of abemaciclib and niraparib in early stage HR breast cancer
SECONDARY OBJECTIVES
I To determine clinical response to treatment II To determine pathologic response to treatment III To determine feasibility of combination as determined by no delay to standard of care breast surgery
EXPLORATORY OBJECTIVE
I To assess occurrence of secondary myelodysplastic syndrome MDSacute myeloid leukemia AML malignancy
OUTLINE This is a phase 1 dose-escalation study of abemaciclib in combination with niraparib followed by a dose-expansion study
Patients receive abemaciclib orally PO twice daily BID and niraparib PO once daily QD Treatment repeats every 28 days for up to 2-4 cycles in the absence of disease progression or unacceptable toxicity Patients who complete 4 cycles undergo standard of care mastectomy or lumpectomy Patients demonstrating progressive disease after only 2 cycles are switched to receive standard of care chemotherapy prior to undergoing mastectomy or lumpectomy
Patients are followed up at 30 days after date of surgery every 3 months for the first 6 months every 6 months for 2 years then annually for up to 5 years from date of surgery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| NCI-2020-03813 | REGISTRY | None | None |
| STUDY00021243 | OTHER | OHSU Knight Cancer Institute | None |