Ignite Creation Date:
2024-05-06 @ 12:53 PM
Last Modification Date:
2024-10-26 @ 1:05 PM
Study NCT ID:
NCT03870919
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-12-07
First Post:
2019-03-06
Brief Title:
Locoregional Treatment and Palbociclib in de Novo Treatment Naive Stage IV ER HER2- Breast Cancer Patients
Sponsor:
UNICANCER
Organization:
UNICANCER
Study Overview
Official Title:
PALbociclib in Advanced Breast Cancer Therapy INtegrating locorEgional Treatment and Palbociclib in de Novo Treatment Naive Stage IV ER HER2- Breast Cancer Patients
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
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:
PALATINE
Brief Summary:
Approximately 35 to 6 of newly diagnosed breast cancer patients are stage IV metastatic De novo metastatic breast cancer accounts for 20 to 25 of these cases Despite a decrease in mortality in Europe and North America due to early detection and access to treatment breast cancer remains the 2ⁿᵈ leading cause of cancer deaths in developed countries after lung cancer and the worlds leading cause
In the ESME French national retrospective cohort NCT03275311 the newly diagnosed estrogen receptor ER-positive and HER2-negative luminal metastatic patients had a 591 months overall survival OS for pre-menopausal women and 447 months for postmenopausal women In the same cohort the median OS was 474 months for de novo metastatic patients with hormone receptor HR-positive HER2-negative breast cancer
The most important current treatment for metastatic breast cancer remains systemic therapy Surgery and radiation are mainly used to treat symptoms However more than 15 retrospective studies have assessed the impact of locoregional treatment on relapse and OS These studies suggested an improvement of the OS in patients with de novo metastatic breast cancer thanks to the addition of locoregional treatment to systemic therapy Recent data from the ESME cohort suggest that patients with de novo luminal or HER2-positive metastatic breast cancer may benefit from local treatment of the primary tumor
Several prospective trials have attempted to demonstrate the benefit of locoregional treatment with mixed results This can be explained by a limited power of statistical analysis on the recruitment of patients with breast cancer of all types and on a limited access to effective systemic therapies in some cases and all before the area of anti CD46 which is the current standard treatment in patients with HR-positive HER2-negative luminal metastatic disease
However guidelines indicate that a multimodal approach including curative locoregional treatments should be considered As a result many clinicians offer locoregional treatment of the primary tumor especially if there is a good response to the first line of systematic treatment
Taken together these data underscore the need for an evaluation of the value of combined therapy - endocrine therapy - CDK46 inhibitor and locoregional treatment - in this population of patients with newly diagnosed HR-positive HER2-negative breast cancer
In the ESME French national retrospective cohort NCT03275311 the newly diagnosed estrogen receptor ER-positive and HER2-negative luminal metastatic patients had a 591 months overall survival OS for pre-menopausal women and 447 months for postmenopausal women In the same cohort the median OS was 474 months for de novo metastatic patients with hormone receptor HR-positive HER2-negative breast cancer
The most important current treatment for metastatic breast cancer remains systemic therapy Surgery and radiation are mainly used to treat symptoms However more than 15 retrospective studies have assessed the impact of locoregional treatment on relapse and OS These studies suggested an improvement of the OS in patients with de novo metastatic breast cancer thanks to the addition of locoregional treatment to systemic therapy Recent data from the ESME cohort suggest that patients with de novo luminal or HER2-positive metastatic breast cancer may benefit from local treatment of the primary tumor
Several prospective trials have attempted to demonstrate the benefit of locoregional treatment with mixed results This can be explained by a limited power of statistical analysis on the recruitment of patients with breast cancer of all types and on a limited access to effective systemic therapies in some cases and all before the area of anti CD46 which is the current standard treatment in patients with HR-positive HER2-negative luminal metastatic disease
However guidelines indicate that a multimodal approach including curative locoregional treatments should be considered As a result many clinicians offer locoregional treatment of the primary tumor especially if there is a good response to the first line of systematic treatment
Taken together these data underscore the need for an evaluation of the value of combined therapy - endocrine therapy - CDK46 inhibitor and locoregional treatment - in this population of patients with newly diagnosed HR-positive HER2-negative breast cancer
Detailed Description:
None
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 |
|---|---|---|---|
| 2019-A00570-57 | REGISTRY | ANSM | None |