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Trial Title:
Trans-RosaLEE Study: a Biomarker-directed, Translational Study
NCT ID:
NCT05529862
Condition:
Advanced or Metastatic Breast Cancer (BC)
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Basic Science
Masking:
None (Open Label)
Intervention:
Intervention type:
Genetic
Intervention name:
Pre-treatment biopsy
Description:
Pre-treatment fragments will be collected during the biopsy visit organised as part of
routine medical practice, prior to the start of treatment with ribociclib + ET
Arm group label:
Locally advanced or metastatic Breast Cancer Women
Intervention type:
Genetic
Intervention name:
Post treatment biopsy
Description:
Post-treatment fragments will be collected during a biopsy visit specifically planned for
Trans-RosaLEE study.
Arm group label:
Locally advanced or metastatic Breast Cancer Women
Intervention type:
Genetic
Intervention name:
Pre treatment blood sampling
Description:
Sampling of 4 EDTA Tubes (4ml) and 2 Streck tubes (10ml)
Arm group label:
Locally advanced or metastatic Breast Cancer Women
Intervention type:
Genetic
Intervention name:
Post treatment blood sampling
Description:
Sampling of 2 Streck tubes (10ml)
Arm group label:
Locally advanced or metastatic Breast Cancer Women
Summary:
Hormone receptor (HR)-positive and HER2-negative (HR+/HER2-) metastatic/advanced breast
cancer (mBC) is a major public health issue. During the last decades, a therapeutic
challenge was to overcome the tumor's 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 CDK4/6 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 HR+/HER2- 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
RH+/HER2- 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 and/or 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 tumor's 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Patients included in the RosaLEE study.
2. Patients having read and signed the ICF relative to Trans-RosaLEE.
3. Tumour material: primary and/or metastatic tumour sample, either available as frozen
and collected within 3 months before V0, or newly collected before ribociclib + ET
treatment initiation.
Brain metastases and non-osteolytic bone metastases will be considered as
non-collectable/biopsable.
4. Patient affiliated to the national "Social Security" regimen or beneficiary of this
regimen.
Exclusion Criteria:
1. Not enrolled in RosaLEE.
2. Brain metastasis and non-osteolytic bone metastases as only metastatic sites, if no
available frozen tumour sample already collected within 3 months before V0.
3. Tumour material not collected before ribociclib + ET initiation.
4. Person subject to a legal protection measure (adult under guardianship, curatorship
or safeguard of justice), or unable to give their consent.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Institut Paoli Calmettes
Address:
City:
Marseille
Country:
France
Status:
Recruiting
Contact:
Last name:
Dominique Genre, MD
Phone:
0033491223778
Email:
drci.up@ipc.unicancer.fr
Start date:
June 20, 2023
Completion date:
October 1, 2027
Lead sponsor:
Agency:
Institut Paoli-Calmettes
Agency class:
Other
Collaborator:
Agency:
Novartis Pharmaceuticals
Agency class:
Industry
Source:
Institut Paoli-Calmettes
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05529862
