Ignite Creation Date:
2024-05-06 @ 2:14 PM
Last Modification Date:
2024-10-26 @ 1:27 PM
Study NCT ID:
NCT04256941
Status:
COMPLETED
Last Update Posted:
2024-04-16
First Post:
2020-01-21
Brief Title:
Aromatase Inhibitor Therapy With or Without Fulvestrant for the Treatment of HR Positive Metastatic Breast Cancer With an ERS1 Activating Mutation the INTERACT Study
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
INTERACT- Integrated Evaluation of Resistance and Actionability Using Circulating Tumor DNA in HR Positive Metastatic Breast Cancers
Status:
COMPLETED
Status Verified Date:
2024-04
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 studies how well letrozole anastrozole or fulvestrant work when given together with ribociclib palbociclib andor abemaciclib in treating patients with hormone receptor HR positive breast cancer that has spread to other places in the body metastatic and has an ERS1 activating mutation Letrozole anastrozole ribociclib palbociclib and abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Estrogen can cause the growth of breast cancer cells Hormone therapy using fulvestrant may fight breast cancer by blocking the use of estrogen by the tumor cells It is not yet known if giving letrozole anastrozole or fulvestrant with ribociclib palbociclib andor abemaciclib will work better in treating patients with breast cancer
Detailed Description:
PRIMARY OBJECTIVE
I To assess progression free survival PFS with transition to fulvestrant compared with continuing aromatase inhibitor AI therapy in patients with emergence of estrogen receptor 1 ESR1 mutations in plasma
SECONDARY OBJECTIVES
I To assess circulating tumor deoxyribonucleic acid ctDNA ESR1 mutant allele fraction MAF and kinetics with fulvestrant compared with AI
II To assess the prevalence of ESR1 mutations in patients with secondary resistance to endocrine therapy
III To correlate ctDNA with cancer antigens CA 15-3 tumor marker changes IV To assess overall survival OS with transition to fulvestrant compared with continuing AI therapy in patients with emergence of ESR1 mutations
V To assess PFS and time to next treatment TTNT on next line of therapy after progression on fulvestrant versus vs AI in combination with CDKI
EXPLORATORY OBJECTIVES
I Characterize other co-existing actionable genomic alterations of interest in relation to ESR1 and clinical outcomes
II To determine frequency of other actionable genomic alterations and frequency of enrollment on genotype-matched therapy
OUTLINE Patients are randomized to 1 of 2 arms
ARM I Patients receive ribociclib orally PO once daily QD palbociclib PO QD on days 1-21 andor abemaciclib PO twice daily BID on days 1-28 Patients also receive fulvestrant intramuscularly IM for 2 injections over 1-2 minutes each on days 1 and 15 of cycle 1 and day 2 of subsequent cycles Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity
ARM II Patients receive ribociclib orally PO QD palbociclib PO QD on days 1-21 andor abemaciclib PO BID on days 1-28 Patients also receive letrozole PO QD or anastrozole PO QD on days 1-28 Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up for 30 days
I To assess progression free survival PFS with transition to fulvestrant compared with continuing aromatase inhibitor AI therapy in patients with emergence of estrogen receptor 1 ESR1 mutations in plasma
SECONDARY OBJECTIVES
I To assess circulating tumor deoxyribonucleic acid ctDNA ESR1 mutant allele fraction MAF and kinetics with fulvestrant compared with AI
II To assess the prevalence of ESR1 mutations in patients with secondary resistance to endocrine therapy
III To correlate ctDNA with cancer antigens CA 15-3 tumor marker changes IV To assess overall survival OS with transition to fulvestrant compared with continuing AI therapy in patients with emergence of ESR1 mutations
V To assess PFS and time to next treatment TTNT on next line of therapy after progression on fulvestrant versus vs AI in combination with CDKI
EXPLORATORY OBJECTIVES
I Characterize other co-existing actionable genomic alterations of interest in relation to ESR1 and clinical outcomes
II To determine frequency of other actionable genomic alterations and frequency of enrollment on genotype-matched therapy
OUTLINE Patients are randomized to 1 of 2 arms
ARM I Patients receive ribociclib orally PO once daily QD palbociclib PO QD on days 1-21 andor abemaciclib PO twice daily BID on days 1-28 Patients also receive fulvestrant intramuscularly IM for 2 injections over 1-2 minutes each on days 1 and 15 of cycle 1 and day 2 of subsequent cycles Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity
ARM II Patients receive ribociclib orally PO QD palbociclib PO QD on days 1-21 andor abemaciclib PO BID on days 1-28 Patients also receive letrozole PO QD or anastrozole PO QD on days 1-28 Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up for 30 days
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-2019-08825 | REGISTRY | None | None |
| 2018-0287 | OTHER | M D Anderson Cancer Center | None |