Ignite Creation Date:
2024-05-06 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 12:40 PM
Study NCT ID:
NCT03439735
Status:
RECRUITING
Last Update Posted:
2024-04-08
First Post:
2017-12-08
Brief Title:
Determinants of Resistance to Endocrine Therapy and a Cyclin-dependent Kinases 4 and 6 CDK46 Inhibitor for HR MBC
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
Official Title:
Prospective Evaluation of Determinants of Resistance to Endocrine Therapy and a Cyclin-dependent Kinases 4 and 6 CDK46 Inhibitor in Hormone Receptor HR Positive Metastatic Breast Cancer MBC
Status:
RECRUITING
Status Verified Date:
2024-10
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:
The goal of this research study is to determine if the investigators can predict which participants will respond to endocrine therapy and a cyclin-dependent kinases 4 and 6 CDK46 inhibitor for metastatic breast cancer and which participants will not Investigators will use information from the tumor tissue and serial blood samples Investigators hope that a deeper understanding of which participants will respond to this combination and how resistance emerges will allow the investigators to better tailor therapies for metastatic breast cancer
Subjects will have archived tissue or new biopsy collected at study enrollment This tissue will undergo special molecular testing Subjects will also have blood collected at study enrollment and periodically thereafter This blood will also undergo special molecular testing Information from this testing will not be available to subjects or their treating physicians as the investigators do not know how this information should impact treatment
The investigators will collect information about which treatment the subjects receive and how their cancer responds
Any man or woman being seen at Johns Hopkins for treatment of newly diagnosed estrogen receptor positive ER andor progesterone receptor positive PR metastatic breast cancer may be eligible
Subjects will have archived tissue or new biopsy collected at study enrollment This tissue will undergo special molecular testing Subjects will also have blood collected at study enrollment and periodically thereafter This blood will also undergo special molecular testing Information from this testing will not be available to subjects or their treating physicians as the investigators do not know how this information should impact treatment
The investigators will collect information about which treatment the subjects receive and how their cancer responds
Any man or woman being seen at Johns Hopkins for treatment of newly diagnosed estrogen receptor positive ER andor progesterone receptor positive PR metastatic breast cancer may be eligible
Detailed Description:
Resistance to endocrine therapy ET invariably develops in patients with estrogen andor progesterone receptor ER PR positive metastatic breast cancer MBC Data regarding primary resistance and patterns of emergence of acquired resistance in patients treated with endocrine therapy ET and cyclin dependent kinase 4 and 6 CDK46 inhibitors are limited Understanding these mechanisms could result in improved selection of treatment options and provide new targets for therapy development In this study we aim to identify and characterize determinants of intrinsic and acquired resistance to endocrine therapy in patients with hormone receptor HR positive human epidermal growth factor receptor 2 HER2 negative MBC treated with the combination of endocrine therapy aromatase inhibitor or fulvestrant and a CDK46 inhibitor
Investigators will determine the prevalence of genomic alterations at baseline in the primary tumor metastatic tissue and plasma tumor DNA ptDNA including in the gene encoding estrogen receptor- alpha ESR1 The mutational tumor burden in the primary tumor metastatic tumor and blood will be assessed Blood samples will be collected at several time points allowing the detection of changes in molecular markers over time We will further characterize tissue markers associated with progression and duration of response by evaluating these markers in available tissue obtained at progression Investigators goal is to evaluate the prevalence and role of known alterations determining endocrine resistance in patients with metastatic disease as knowledge regarding this population remains limitedThe investigators also hope to unveil novel markers of endocrine resistance
Investigators will determine the prevalence of genomic alterations at baseline in the primary tumor metastatic tissue and plasma tumor DNA ptDNA including in the gene encoding estrogen receptor- alpha ESR1 The mutational tumor burden in the primary tumor metastatic tumor and blood will be assessed Blood samples will be collected at several time points allowing the detection of changes in molecular markers over time We will further characterize tissue markers associated with progression and duration of response by evaluating these markers in available tissue obtained at progression Investigators goal is to evaluate the prevalence and role of known alterations determining endocrine resistance in patients with metastatic disease as knowledge regarding this population remains limitedThe investigators also hope to unveil novel markers of endocrine resistance
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?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IRB00143030 | OTHER | JHM-IRB | None |