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NCT05697146Active, not recruiting

Ribociclib Real-world Treatment Patterns and Clinical Outcomes Among Women With HR+/HER2- Advanced or Metastatic Breast Cancer in France

Ribociclib Real-world Treatment Patterns and Clinical Outcomes Among Women With HR+/HER2- Advanced or Metastatic Breast Cancer in France: a National, Multicenter, Prospective, Non-interventional Study

Source: ClinicalTrials.gov · Last updated 16 Mar 2026

Brief summary (registry, in English)

This study is a national, multicenter, prospective, non-interventional study in women with HR+/HER2- locally advanced or metastatic breast cancer (BC), for which a prior clinical decision to initiate ribociclib + endocrine therapy (ET) treatment according to the marketing authorization has been taken and was taken independent and prior to study participation decision.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
1019 (actual)
First submitted
8 Nov 2022
Start date
13 Dec 2022
Primary completion date
30 Jun 2028
Lead sponsor
Novartis Pharmaceuticals
NCT number
NCT05697146

What you commit to

  • Study type: Observational
  • Participants enrolled: 1019
  • From 13 Dec 2022 to the primary completion date, 30 Jun 2028
  • 68 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients for whom AI or fulvestrant in monotherapy has been initiated \> 28 days before inclusion.
  • Participation in any clinical study involving investigational therapy except for the Trans-RosaLEE study, conducted by the IPC.

Other

  • Patients for whom ribociclib + AI in treatment combination has been initiated before inclusion.
  • Patients for whom ribociclib + fulvestrant in treatment combination has been initiated before inclusion.
  • Patient who is pregnant or has expressed desire for pregnancy during Ribociclib treatment.

Who the study is looking for

  • Patients who meet all of the following criteria will be included in the RosaLEE study:
  • Adult women aged ≥ 18 years old at inclusion.
  • Pre-/Peri-/Postmenopausal women with locally advanced or metastatic HR+/HER2- BC.
  • Prior clinical decision (independent of study participation)to initiate ribociclib + ET treatment according to the marketing authorization.
  • Patients having given their non-objection to participate in the study.
  • Patients presenting with medical conditions to be treated with ribociclib + ET according to the summary of product characteristics.

Age in the registry: 18 years to 99 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (68)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Novartis Investigative Site
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AmiensFranceUnknown status
Novartis Investigative Site
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ArgenteuilFranceUnknown status
Novartis Investigative Site
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AvignonFranceUnknown status
Novartis Investigative Site
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BayonneFranceUnknown status
Novartis Investigative Site
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BesançonFranceUnknown status
Novartis Investigative Site
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BéziersFranceUnknown status
Novartis Investigative Site
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Brive-la-GaillardeFranceUnknown status
Novartis Investigative Site
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CannesFranceUnknown status
Novartis Investigative Site
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CarcassonneFranceUnknown status
Novartis Investigative Site
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Chalon-sur-SaôneFranceUnknown status
Novartis Investigative Site
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Chambray-lès-ToursFranceUnknown status
Novartis Investigative Site
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Champigny-sur-MarneFranceUnknown status
Novartis Investigative Site
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CherbourgFranceUnknown status
Novartis Investigative Site
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CholetFranceUnknown status
Novartis Investigative Site
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Clermont-FerrandFranceUnknown status
Novartis Investigative Site
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ColmarFranceUnknown status
Novartis Investigative Site
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CompiègneFranceUnknown status
Novartis Investigative Site
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Corbeil-EssonnesFranceUnknown status
Novartis Investigative Site
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CréteilFranceUnknown status
Novartis Investigative Site
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DechyFranceUnknown status
Novartis Investigative Site
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DijonFranceUnknown status
Novartis Investigative Site
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DunkirkFranceUnknown status
Novartis Investigative Site
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EaubonneFranceUnknown status
Novartis Investigative Site
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FréjusFranceUnknown status
Novartis Investigative Site
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GleizéFranceUnknown status
Novartis Investigative Site
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GrenobleFranceUnknown status
Novartis Investigative Site
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La Roche-sur-YonFranceUnknown status
Novartis Investigative Site
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LibourneFranceUnknown status
Novartis Investigative Site
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LyonFranceUnknown status
Novartis Investigative Site
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Lyon 08FranceUnknown status
Novartis Investigative Site
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MarseilleFranceUnknown status
Novartis Investigative Site
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MetzFranceUnknown status
Novartis Investigative Site
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Metz-TessyFranceUnknown status
Novartis Investigative Site
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MontbelliardFranceUnknown status
Novartis Investigative Site
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MontpellierFranceUnknown status
Novartis Investigative Site
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NancyFranceUnknown status
Novartis Investigative Site
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Neuilly-sur-SeineFranceUnknown status
Novartis Investigative Site
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NiceFranceUnknown status
Novartis Investigative Site
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NîmesFranceUnknown status
Novartis Investigative Site
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NiortFranceUnknown status
Novartis Investigative Site
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OsnyFranceUnknown status
Novartis Investigative Site
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ParisFranceUnknown status
Novartis Investigative Site
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PerpignanFranceUnknown status
Novartis Investigative Site
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Pierre-BéniteFranceUnknown status
Novartis Investigative Site
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PoitiersFranceUnknown status
Novartis Investigative Site
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ReimsFranceUnknown status
Novartis Investigative Site
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RouenFranceUnknown status
Novartis Investigative Site
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Saint-CloudFranceUnknown status
Novartis Investigative Site
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Saint-DenisFranceUnknown status
Novartis Investigative Site
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Saint-DizierFranceUnknown status
Novartis Investigative Site
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Saint-EtienneFranceUnknown status
Novartis Investigative Site
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Saint-NazaireFranceUnknown status
Novartis Investigative Site
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Saint-PierreFranceUnknown status
Novartis Investigative Site
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Saint-VallierFranceUnknown status
Novartis Investigative Site
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SarcellesFranceUnknown status
Novartis Investigative Site
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SoyauxFranceUnknown status
Novartis Investigative Site
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St-MaloFranceUnknown status
Novartis Investigative Site
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SuresnesFranceUnknown status
Novartis Investigative Site
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ThionvilleFranceUnknown status
Novartis Investigative Site
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ToulonFranceUnknown status
Novartis Investigative Site
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Toulon La SeyneFranceUnknown status
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ToulouseFranceUnknown status
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ValenceFranceUnknown status
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ValenciennesFranceUnknown status
Novartis Investigative Site
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Vandœuvre-lès-NancyFranceUnknown status
Novartis Investigative Site
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VantouxFranceUnknown status
Novartis Investigative Site
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VillejuifFranceUnknown status
Novartis Investigative Site
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VilleurbanneFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.