Advanced or Metastatic Breast Cancer (BC)TransRosaLEENCT05529862
Trans-RosaLEE Study: a Biomarker-directed, Translational Study
A study testing Pre-treatment biopsy, Post treatment biopsy and Pre treatment blood sampling in people with Advanced or Metastatic Breast Cancer (BC), run by Institut Paoli-Calmettes at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Advanced or Metastatic Breast Cancer (BC)
- What is being tested?
- Pre-treatment biopsy, Post treatment biopsy and Pre treatment blood sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jun 2023to 1 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients included in the RosaLEE study.
- Patients having read and signed the ICF relative to Trans-RosaLEE.
- 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.
- Patient affiliated to the national "Social Security" regimen or beneficiary of this regimen.
Who cannot join
- Not enrolled in RosaLEE.
- Brain metastasis and non-osteolytic bone metastases as only metastatic sites, if no available frozen tumour sample already collected within 3 months before V0.
- Tumour material not collected before ribociclib + ET initiation.
- Person subject to a legal protection measure (adult under guardianship, curatorship or safeguard of justice), or unable to give their consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Trans-RosaLEE Study: a Biomarker-directed, Translational Study of High-throughput Molecular Profiling of HR+/HER2- Metastatic Breast Cancer Treated With Endocrine Therapy and Ribociclib.
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.
Read more
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.
- Being tested
- Pre-treatment biopsy, Post treatment biopsy, Pre treatment blood sampling, Post treatment blood sampling
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-treatment biopsyGenetic
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
Post treatment biopsyGenetic
Post-treatment fragments will be collected during a biopsy visit specifically planned for Trans-RosaLEE study.
Pre treatment blood samplingGenetic
Sampling of 4 EDTA Tubes (4ml) and 2 Streck tubes (10ml)
Post treatment blood samplingGenetic
Sampling of 2 Streck tubes (10ml)
| Study group | Role | What they receive |
|---|---|---|
| Locally advanced or metastatic Breast Cancer Women | Experimental | Study Procedures:
* Additional tumour sampling during the pre-treatment biopsy scheduled as per routine care,
* A post-treatment tumour biopsy,
* One pre-treatment and one post-treatment blood sampling. Receives: Genetic: Pre-treatment biopsy; Genetic: Post treatment biopsy; Genetic: Pre treatment blood sampling; Genetic: Post treatment blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Molecular alterations post- versus pre-treatment
Occurrence of molecular alterations, including DNA copy number, gene mutations by WES and messenger RNA (mRNA) expression profiles by RNA-seq in paired post- versus pre-treatment samples.
Measured: At the date of first documented progression, assessed up to 54 months
Secondary outcomes (10)
Molecular alterations associated with progression free survival
Occurrence of molecular alterations in pre-treatment samples, such as DNA copy number alterations and mutational profiles analysed by WES, and mRNA expression profiles analysed by RNA-seq, associated with progression free survival.
Measured: At 3 years after treatment initiation (Ribociclib+hormone therapy)
Molecular alterations pre and post-treatment
Occurrence of molecular alterations, including DNA copy number, gene mutations by WES and mRNA expression profiles by RNA-seq in the totality of pre- and post-treatment samples (paired and unpaired).
Measured: At the date of first documented progression, assessed up to 54 months
Pre treatment molecular alterations associated with tumor response
Occurrence of molecular alterations in pre-treatment samples, such as DNA copy number alterations and mutational profiles analysed by WES and mRNA expression profiles analysed by RNA-seq, associated with tumour response according to RECIST 1.1 guidelines (complete and partial responses).
Measured: At 3 years after treatment initiation (Ribociclib+hormone therapy)
Molecular alterations therapeutically actionable
Occurrence of molecular alterations in pre- and post-treatment samples, such as DNA copy number alterations and mutational profiles analysed by WES, which are therapeutically actionable according to the ESCAT scale.
Measured: At the date of first documented progression, assessed up to 54 months
Percentage of patients with molecular alterations therapeutically actionable
Percentage of patients with molecular alterations such as DNA mutations and/or copy number alterations by WES, which are therapeutically actionable according to the ESCAT scale, in pre- and post-treatment samples.
Measured: Through study completion, an average of 54 months
Percentage of patients with modification of the therapeutic strategy derived from the molecular profiling
Percentage of patients for which modification of the therapeutic strategy could have been derived from the molecular profiling of the post-treatment samples compared to that of the pre-treatment samples, according to the ESCAT scale.
Measured: Through study completion, an average of 54 months
IHC profile ER
IHC profile ER of pre- and post-treatment samples.
Measured: At the date of first documented progression, assessed up to 54 months
IHC profile PgR
IHC profile PgR of pre- and post-treatment samples.
Measured: At the date of first documented progression, assessed up to 54 months
IHC profile HER2
IHC profile HER2 of pre- and post-treatment samples.
Measured: At the date of first documented progression, assessed up to 54 months
Molecular subtypes PAM50
Molecular subtypes PAM50 of pre- and post-treatment samples.
Measured: At the date of first documented progression, assessed up to 54 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start20 Jun 2023
- Primary completion1 Nov 2028 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced or Metastatic Breast Cancer (BC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- François Bertucci, MD PhD, Principal investigator, Institut Paoli-Calmettes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05529862
- Sponsor's protocol ID
- TransRosaLEE-IPC 2021-075
- Acronym
- TransRosaLEE
- Status last verified
- Apr 2025
- First submitted
- 30 Aug 2022
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trans-RosaLEE Study: a Biomarker-directed, Translational Study of High-throughput Molecular Profiling of HR+/HER2- Metastatic Breast Cancer Treated With Endocrine Therapy and Ribociclib.
- ClinicalTrials.gov ID
- NCT05529862
- Acronym / sponsor ID
- TransRosaLEE / TransRosaLEE-IPC 2021-075
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Study start
- 20 Jun 2023 (actual)
- Primary completion
- 1 Nov 2028 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 7 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Locally advanced or metastatic Breast Cancer Women | Experimental | Genetic: Pre-treatment biopsy, Genetic: Post treatment biopsy, Genetic: Pre treatment blood sampling, Genetic: Post treatment blood samplingStudy Procedures: * Additional tumour sampling during the pre-treatment biopsy scheduled as per routine care, * A post-treatment tumour biopsy, * One pre-treatment and one post-treatment blood sampling. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients included in the RosaLEE study.
- Patients having read and signed the ICF relative to Trans-RosaLEE.
- 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.
- Patient affiliated to the national "Social Security" regimen or beneficiary of this regimen.
Key exclusion criteria (4 listed)
- Not enrolled in RosaLEE.
- Brain metastasis and non-osteolytic bone metastases as only metastatic sites, if no available frozen tumour sample already collected within 3 months before V0.
- Tumour material not collected before ribociclib + ET initiation.
- Person subject to a legal protection measure (adult under guardianship, curatorship or safeguard of justice), or unable to give their consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pre-treatment biopsyPre-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 | Genetic | Locally advanced or metastatic Breast Cancer Women |
| Post treatment biopsyPost-treatment fragments will be collected during a biopsy visit specifically planned for Trans-RosaLEE study. | Genetic | Locally advanced or metastatic Breast Cancer Women |
| Pre treatment blood samplingSampling of 4 EDTA Tubes (4ml) and 2 Streck tubes (10ml) | Genetic | Locally advanced or metastatic Breast Cancer Women |
| Post treatment blood samplingSampling of 2 Streck tubes (10ml) | Genetic | Locally advanced or metastatic Breast Cancer Women |
Primary outcome
Molecular alterations post- versus pre-treatment
Time frame: At the date of first documented progression, assessed up to 54 months
Occurrence of molecular alterations, including DNA copy number, gene mutations by WES and messenger RNA (mRNA) expression profiles by RNA-seq in paired post- versus pre-treatment samples.
10 secondary outcomes
Molecular alterations associated with progression free survival
Time frame: At 3 years after treatment initiation (Ribociclib+hormone therapy)
Molecular alterations pre and post-treatment
Time frame: At the date of first documented progression, assessed up to 54 months
Pre treatment molecular alterations associated with tumor response
Time frame: At 3 years after treatment initiation (Ribociclib+hormone therapy)
Molecular alterations therapeutically actionable
Time frame: At the date of first documented progression, assessed up to 54 months
Percentage of patients with molecular alterations therapeutically actionable
Time frame: Through study completion, an average of 54 months
Percentage of patients with modification of the therapeutic strategy derived from the molecular profiling
Time frame: Through study completion, an average of 54 months
IHC profile ER
Time frame: At the date of first documented progression, assessed up to 54 months
IHC profile PgR
Time frame: At the date of first documented progression, assessed up to 54 months
IHC profile HER2
Time frame: At the date of first documented progression, assessed up to 54 months
Molecular subtypes PAM50
Time frame: At the date of first documented progression, assessed up to 54 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
François Bertucci, MD PhD principal investigator
Institut Paoli-Calmettes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-treatment biopsy, Post treatment biopsy and Pre treatment blood sampling in people with Advanced or Metastatic Breast Cancer (BC), run by Institut Paoli-Calmettes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Molecular alterations post- versus pre-treatment (time frame: At the date of first documented progression, assessed up to 54 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.