Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06450314
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-10
First Post:
2024-06-04
Brief Title:
Decreasing Treatment for Metastatic HER2-Positive Breast Cancer With Undectable Cancer Levels in Blood Tests
Sponsor:
UNICANCER
Organization:
UNICANCER
Study Overview
Official Title:
De-escalation of Medical Therapies in HER2-positive Metastatic Breast Cancer in Long-term Persistent Response and Minimal Residual Disease Undetectable in Circulating Tumor DNA
Status:
NOT_YET_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:
HEROES
Brief Summary:
Heroes is a multicentre national non-randomized open-label phase 2 study The goal of this clinical trial is to evaluate the feasibility of therapeutic de-escalation in HER2-positive metastatic breast cancer with disease controlled after 2 years of maintenance treatment with anti-HER2 targeted therapy AND ctDNA negative testing
The main question it aims to answer is
Is it possible to identify patients for whom temporary or permanent discontinuation of treatment is possible without impacting prognosis
The main question it aims to answer is
Is it possible to identify patients for whom temporary or permanent discontinuation of treatment is possible without impacting prognosis
Detailed Description:
Metastatic breast cancer remains a difficult disease to cure in the majority of cases Improved biological knowledge has made it possible to separate these heterogeneous pathologies into several subtypes For the HER2 subtype which accounts for around 15 of breast cancers very significant progress has been made in recent years with innovative treatments known as anti-HER2 therapies trastuzumab pertuzumab T-DM1 T-DXd Long-term disease control has been achieved in at least 20 of these patients with these new treatments
However the treatments are continued indefinitely impacting patients quality of life through toxicity and chronic administration It is possible that for some patients these treatments can be discontinued while maintaining surveillance To assess this possibility new biological tools notably the search for circulating tumor DNA ctDNA look very promising for detecting any tumor cells in the body even to very small traces minimal residual disease
The primary objective of this trial is to evaluate the feasibility of therapeutic de-escalation temporary or complete discontinuation in patients with HER2-positive metastatic breast cancer whose disease is controlled after 2 years of maintenance treatment with anti-HER2 targeted therapy AND a negative ctDNA test
However the treatments are continued indefinitely impacting patients quality of life through toxicity and chronic administration It is possible that for some patients these treatments can be discontinued while maintaining surveillance To assess this possibility new biological tools notably the search for circulating tumor DNA ctDNA look very promising for detecting any tumor cells in the body even to very small traces minimal residual disease
The primary objective of this trial is to evaluate the feasibility of therapeutic de-escalation temporary or complete discontinuation in patients with HER2-positive metastatic breast cancer whose disease is controlled after 2 years of maintenance treatment with anti-HER2 targeted therapy AND a negative ctDNA test
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-509811-98-00 | CTIS | None | None |