NCT05529862

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
115

participants targeted

Target at P50-P75 for not_applicable

Timeline
30mo left

Started Jun 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress54%
Jun 2023Nov 2028

First Submitted

Initial submission to the registry

August 30, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 7, 2022

Completed
10 months until next milestone

Study Start

First participant enrolled

June 20, 2023

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2028

Last Updated

January 22, 2026

Status Verified

April 1, 2025

Enrollment Period

5.4 years

First QC Date

August 30, 2022

Last Update Submit

January 20, 2026

Conditions

Advanced or Metastatic Breast Cancer (BC)

Outcome Measures

Primary Outcomes (1)

  • 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.

    At the date of first documented progression, assessed up to 54 months

Secondary Outcomes (10)

  • Molecular alterations associated with progression free survival

    At 3 years after treatment initiation (Ribociclib+hormone therapy)

  • Molecular alterations pre and post-treatment

    At the date of first documented progression, assessed up to 54 months

  • Pre treatment molecular alterations associated with tumor response

    At 3 years after treatment initiation (Ribociclib+hormone therapy)

  • Molecular alterations therapeutically actionable

    At the date of first documented progression, assessed up to 54 months

  • Percentage of patients with molecular alterations therapeutically actionable

    Through study completion, an average of 54 months

  • +5 more secondary outcomes

Study Arms (1)

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.

Genetic: Pre-treatment biopsyGenetic: Post treatment biopsyGenetic: Pre treatment blood samplingGenetic: Post treatment blood sampling

Interventions

Pre treatment blood samplingGENETIC

Sampling of 4 EDTA Tubes (4ml) and 2 Streck tubes (10ml)

Locally advanced or metastatic Breast Cancer Women
Post treatment blood samplingGENETIC

Sampling of 2 Streck tubes (10ml)

Locally advanced or metastatic Breast Cancer Women
Post treatment biopsyGENETIC

Post-treatment fragments will be collected during a biopsy visit specifically planned for Trans-RosaLEE study.

Locally advanced or metastatic Breast Cancer Women
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

Locally advanced or metastatic Breast Cancer Women

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Paoli Calmettes

Marseille, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • François Bertucci, MD PhD

    Institut Paoli-Calmettes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2022

First Posted

September 7, 2022

Study Start

June 20, 2023

Primary Completion (Estimated)

November 1, 2028

Study Completion (Estimated)

November 1, 2028

Last Updated

January 22, 2026

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)