Ignite Creation Date:
2024-07-17 @ 10:47 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06486883
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-06-17
Brief Title:
Safety and Efficacy of T-DXd vs CDK46i-based ET as First-line Therapy of HR-positive and HER2-lowUltralow Advanced Breast Cancer Patients Classified as Non-luminal Subtype
Sponsor:
MedSIR
Organization:
MedSIR
Study Overview
Official Title:
A Randomized Phase II Study to Evaluate the Safety and Efficacy of Trastuzumab Deruxtecan Versus CDK46 Inhibitor-based Endocrine Therapy as First-line Therapy of HR-positive and HER2-lowUltralow Advanced Breast Cancer Patients Classified as Non-luminal Subtype According to Gene Expression Profiling
Status:
NOT_YET_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:
PONTIAC
Brief Summary:
This trial studies a type of advanced breast cancer defined as hormone receptor HR-positiveHER2-negative and classified as non-luminal by gene expression profiling PAM50 Patients will be treated with trastuzumab deruxtecan T-DXd or with physicians choice of CDK46 inhibitor CDK46i plus endocrine therapy ET The main purpose of the study is to analyze the efficacy of T-DXd in patients who have HR-positive and HER2-lowultralow advanced breast cancer classified as non-luminal subtype
Detailed Description:
This is an international multicenter two-arm randomized phase II clinical trial for patients with unresectable locally recurrent or metastatic HR-positive and HER2-lowultralow breast cancer classified as non-luminal by gene expression profiling Female or male patients 18 years of age with HR-positive and HER2-lowultralow locally recurrent inoperable or metastatic breast cancer classified as non-luminal subtype by central PAM50 analysis will be enrolled Patients will be randomized to T-DXd 54 mgkg body weight administered as an IV infusion on Day 1 of each 21-day cycle or physicians choice of CDK46 inhibitor plus endocrine therapy The main objective of the study is to demonstrate that first-line T-DXd compared with CDK46i plus ET is superior in prolonging the progression free survival PFS based on investigator assessment in patients with HR-positive HER2-low advanced breast cancer classified as non-luminal by central PAM50 analysis HER2-low population and all patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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