Ignite Creation Date:
2024-05-06 @ 7:10 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05919108
Status:
RECRUITING
Last Update Posted:
2024-06-13
First Post:
2023-06-15
Brief Title:
Neoadjuvant Neratinib in Stage I-III HER2-Mutated Lobular Breast Cancers
Sponsor:
Vanderbilt-Ingram Cancer Center
Organization:
Vanderbilt-Ingram Cancer Center
Study Overview
Official Title:
Neoadjuvant Neratinib in Stage I-III HER2-Mutated Lobular Breast Cancers
Status:
RECRUITING
Status Verified Date:
2024-06
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 II trial tests how well neratinib prior to the primary treatment neoadjuvant works in treating patients with stage I-III HER2 mutated lobular breast cancers Neratinib is in a class of medications called kinase inhibitors It works by blocking the action of an abnormal protein that signals cancer cells to multiply This helps slow or stop the spread of cancer cells Giving neratinib in addition to normal therapy may work better in treating cancer than the endocrine therapy patients would normally receive
Detailed Description:
PRIMARY OBJECTIVE
I Determine efficacy of neoadjuvant neratinib in combination with endocrine therapy
SECONDARY OBJECTIVES
I Determine additional efficacy outcomes of neoadjuvant neratinib in combination with endocrine therapy
II Compare the safety and tolerability of neratinib plus endocrine therapy
CORRELATIVE OBJECTIVE
I Establish HER2-mutant invasive lobular carcinoma ILC organoids
OUTLINE Patients are randomized to 1 of 2 treatments
TREATMENT A Patients receive standard of care endocrine therapy over 4 weeks for 1 cycle Patients undergo breast tissue biopsy during the lead-in windowcycle 1 Patients then endocrine therapy and neratinib orally PO daily for 20 weeks in the absence of disease progression or unacceptable toxicity Patients undergo breast surgery during weeks 24-25 Patients undergo collection of blood samples every 4 weeks while on treatment at weeks 4 and 24 and at time of surgery Patients undergo mammogram ultrasound or breast magnetic resonance imaging MRI prior to surgery
TREATMENT B Patients receive standard of care endocrine therapy and neratinib PO over 4 weeks for 1 cycle Patients undergo breast tissue biopsy during the lead-in windowcycle 1 Patients then continue endocrine therapy and neratinib PO daily for 20 weeks in the absence of disease progression or unacceptable toxicity Patients undergo breast surgery during weeks 24-25 Patients undergo collection of blood samples every 4 weeks while on treatment at weeks 4 and 24 and at time of surgery Patients undergo mammogram ultrasound or breast MRI prior to surgery
After completion of study treatment patients are followed up for 4 weeks after study drugs interruption
I Determine efficacy of neoadjuvant neratinib in combination with endocrine therapy
SECONDARY OBJECTIVES
I Determine additional efficacy outcomes of neoadjuvant neratinib in combination with endocrine therapy
II Compare the safety and tolerability of neratinib plus endocrine therapy
CORRELATIVE OBJECTIVE
I Establish HER2-mutant invasive lobular carcinoma ILC organoids
OUTLINE Patients are randomized to 1 of 2 treatments
TREATMENT A Patients receive standard of care endocrine therapy over 4 weeks for 1 cycle Patients undergo breast tissue biopsy during the lead-in windowcycle 1 Patients then endocrine therapy and neratinib orally PO daily for 20 weeks in the absence of disease progression or unacceptable toxicity Patients undergo breast surgery during weeks 24-25 Patients undergo collection of blood samples every 4 weeks while on treatment at weeks 4 and 24 and at time of surgery Patients undergo mammogram ultrasound or breast magnetic resonance imaging MRI prior to surgery
TREATMENT B Patients receive standard of care endocrine therapy and neratinib PO over 4 weeks for 1 cycle Patients undergo breast tissue biopsy during the lead-in windowcycle 1 Patients then continue endocrine therapy and neratinib PO daily for 20 weeks in the absence of disease progression or unacceptable toxicity Patients undergo breast surgery during weeks 24-25 Patients undergo collection of blood samples every 4 weeks while on treatment at weeks 4 and 24 and at time of surgery Patients undergo mammogram ultrasound or breast MRI prior to surgery
After completion of study treatment patients are followed up for 4 weeks after study drugs interruption
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2023-04468 | REGISTRY | None | None |
| 1R01CA273246-01A1 | NIH | NCI Clinical Trials Reporting Program | httpsreporternihgovquickSearch1R01CA273246-01A1 |