Ignite Creation Date:
2024-05-06 @ 10:16 AM
Last Modification Date:
2024-10-26 @ 12:28 PM
Study NCT ID:
NCT03219476
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-07-27
First Post:
2017-07-12
Brief Title:
Neoadjuvant Endocrine Therapy in Hormone Receptor-Positive Human Epidermal Growth Factor Receptor 2 HER2-Negative Node-Negative Breast Cancer
Sponsor:
Medical College of Wisconsin
Organization:
Medical College of Wisconsin
Study Overview
Official Title:
Neoadjuvant Endocrine Therapy in Hormone Receptor-Positive HER2-Negative Node-Negative Breast Cancer Patients to Assess Responses and Mechanisms of Endocrine Resistance
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
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 is an exploratory interventional study that initiates standard-of-care anti-estrogen treatment preoperatively for four weeks
Detailed Description:
STUDY RATIONALE Patients with hormone receptor HR HER2- node-negative breast cancers generally undergo surgical resection upfront followed by adjuvant chemotherapy if needed in addition to adjuvant endocrine therapy Because endocrine therapy is primarily delivered in the postoperative setting the ability to assess the tumor response to this treatment modality is lost and very difficult to assess This study offers the unique opportunity to assess the responsiveness of breast tumors to endocrine therapy while the tumors are still in vivo by treating patients with endocrine therapy before surgery and assessing molecular changes with treatment By comparing pre- and post-treatment levels of molecular markers in individual tumors the team expects to identify predictors of responsiveness to existing agents and identify new candidate therapeutic targets
PRIMARY OBJECTIVE The primary objective is to determine the frequency of increased HER family of receptor tyrosine kinases protein expression in tumors following treatment with neoadjuvant endocrine therapy and their correlation with Ki-67 tumor responses The team will measure cancer cell protein levels of growth factor receptors of the human epidermal growth factor receptor HER family before and after neoadjuvant endocrine therapy The data will be used to inform a future randomized trial of combined endocrine and the most promising anti-HER targeted therapy
PRIMARY OBJECTIVE The primary objective is to determine the frequency of increased HER family of receptor tyrosine kinases protein expression in tumors following treatment with neoadjuvant endocrine therapy and their correlation with Ki-67 tumor responses The team will measure cancer cell protein levels of growth factor receptors of the human epidermal growth factor receptor HER family before and after neoadjuvant endocrine therapy The data will be used to inform a future randomized trial of combined endocrine and the most promising anti-HER targeted therapy
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