Ignite Creation Date:
2024-05-06 @ 6:03 PM
Last Modification Date:
2024-10-26 @ 2:40 PM
Study NCT ID:
NCT05529862
Status:
RECRUITING
Last Update Posted:
2023-06-23
First Post:
2022-08-30
Brief Title:
Trans-RosaLEE Study a Biomarker-directed Translational Study
Sponsor:
Institut Paoli-Calmettes
Organization:
Institut Paoli-Calmettes
Study Overview
Official Title:
Trans-RosaLEE Study a Biomarker-directed Translational Study of High-throughput Molecular Profiling of HRHER2- Metastatic Breast Cancer Treated With Endocrine Therapy and Ribociclib
Status:
RECRUITING
Status Verified Date:
2022-09
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:
TransRosaLEE
Brief Summary:
Hormone receptor HR-positive and HER2-negative HRHER2- metastaticadvanced breast cancer mBC is a major public health issue During the last decades a therapeutic challenge was to overcome the tumors resistance to endocrine therapy ET Thanks to a better understanding of the molecular mechanisms of this resistance effective new treatments have been developed such as Kisqali ribociclib a molecularly targeted therapy This treatment blocks the growth and division of cancer cells by blocking proteins called CDK46 located inside the cell This treatment taken in combination with ET blocks the harmful effect of hormones estrogen on cancer cell proliferation and represent the standard first-line treatment of patients with HRHER2- mBC
But as with any treatment it is expected that some patients will have a good response and their disease will be stabilized or even in remission while other patients will not benefit from treatment and will relapse In order to make progress it is necessary to identify pre-therapeutic markers predictive of response to this treatment and the molecular mechanisms of this resistance set up by the tumor before or under the effect of the treatment
The Trans-RosaLEE study aims to fill this gap by providing high-throughput molecular profiling DNA and RNA of a collection of tumor and blood samples from patients with RHHER2- mBC scheduled to start treatment with Kisqali ET Samples will be collected just prior to initiation of therapy pre-therapy and just after discontinuation of therapy in the event of disease progression post-therapy
The main objectives of the TransRosaLEE study are
to determine if Kisqali ET treatment causes changes in the DNA andor RNA genes of tumor
to identify whether there is a molecular signature that would predict clinical outcome of patients treated with Kisqali ET tumor response survival
to identify alterations in tumors genes that could be targeted by a specific treatment and that would allow in case of progression of the disease to set up a new adapted treatment
The TransRosaLEE study is a collaborative study between the Paoli-Calmettes Institute France Marseille and the pharmaceutical group Novartis It will take place in up to 90 healthcare institutions in France and 241 patients will be enrolled It is closely linked to the non-interventional study RosaLEE promoted by Novartis
But as with any treatment it is expected that some patients will have a good response and their disease will be stabilized or even in remission while other patients will not benefit from treatment and will relapse In order to make progress it is necessary to identify pre-therapeutic markers predictive of response to this treatment and the molecular mechanisms of this resistance set up by the tumor before or under the effect of the treatment
The Trans-RosaLEE study aims to fill this gap by providing high-throughput molecular profiling DNA and RNA of a collection of tumor and blood samples from patients with RHHER2- mBC scheduled to start treatment with Kisqali ET Samples will be collected just prior to initiation of therapy pre-therapy and just after discontinuation of therapy in the event of disease progression post-therapy
The main objectives of the TransRosaLEE study are
to determine if Kisqali ET treatment causes changes in the DNA andor RNA genes of tumor
to identify whether there is a molecular signature that would predict clinical outcome of patients treated with Kisqali ET tumor response survival
to identify alterations in tumors genes that could be targeted by a specific treatment and that would allow in case of progression of the disease to set up a new adapted treatment
The TransRosaLEE study is a collaborative study between the Paoli-Calmettes Institute France Marseille and the pharmaceutical group Novartis It will take place in up to 90 healthcare institutions in France and 241 patients will be enrolled It is closely linked to the non-interventional study RosaLEE promoted by Novartis
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