A Non-interventional Study for Women With HR-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer to Evaluate the Real-world Effectiveness of Treatment Algorithms Beginning With Ribociclib + AI/FUL, or With Endocrine Therapy or Chemotherapy as First Line Treatment

Breast Cancer Clinical Trial

— RIBANNA  

Official title:

A Non-interventional Study for Women With HR-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer to Evaluate the Real-world Effectiveness of Treatment Algorithms Beginning With Kisqali (Ribociclib) in Combination With an Aromatase Inhibitor/Fulvestrant, or With Endocrine Therapy or Chemotherapy as First Line Treatment

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06311383
• Other study ID #: CLEE011ADE03
• Status: Active, not recruiting
• Start date: October 9, 2017
• Est. completion date: February 16, 2025

Study information

• Verified date: June 2024
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a non-interventional observational study conducted in Germany to evaluate the real-world effectiveness, tolerability, safety, and quality of life in patients with locally advanced/metastatic HR+/HER2- breast cancer treated with one of the following 1st line treatments: Ribociclib + AI/FUL, or endocrine monotherapy, or chemotherapy

Description:

This non-interventional study collects data from clinical practice capturing on effectiveness, safety and tolerability, duration of therapy, and quality of life of ribociclib in combination with an aromatase inhibitor/fulvestrant in daily routine and in line with the respective current German summary of product characteristics. In order to put these results into perspective, data is also collected on patients treated with endocrine therapy or chemotherapy for first line locally advanced or metastatic breast cancer. To gain insight into algorithms and outcome of sequential therapy, up to three lines of treatment are documented within this study. The information gathered and evaluated in this NIS is helping to answer open questions for the treatment of locally advanced/metastatic breast cancer and provides first insights into the treatment reality with ribociclib in this setting. This includes, but is not limited to, the questions on baseline demographics leading to a specific treatment decision, as well as efficacy and clinical routine related to treatment sequencing. In addition, data on the mutation status (including PIK3CA and BRCA1/2) is collected at different time points to generate insights into the clinical routine of mutation testing and to understand its impact on therapy sequencing.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2610
• Est. completion date: February 16, 2025
• Est. primary completion date: February 16, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with a histological diagnosis of locally advanced/metastatic HR+/HER2- breast cancer. Histological diagnosis does not necessarily origin from metastasis, but must reflect the most recent disease status

• No prior systemic treatment for locally advanced/metastatic disease in the palliative setting

• The treating physician has made the decision to treat the patient

• with ribociclib in combination with an aromatase inhibitor or fulvestrant as initial treatment in first line, or

• endocrine therapy as initial treatment in first line (e.g. letrozole, anastrozole, fulvestrant), or

• chemotherapy as initial treatment in first line (e.g. taxanes, capecitabine, with or without bevacizumab)

• Written informed consent of the patient

• Patient who initiated treatment for first line no longer than 4 weeks (28 days) prior to written informed consent for this study

• Planned treatment is in line with the respective current German SmPC ("Summary of product characteristics")

• Patient is =18 years

Exclusion Criteria:

• Patients unable to provide written informed consent

• Contra-indication according to the respective current German SmPC ("Summary of product characteristics"), as judged by the treating physician

• The patient is currently under active treatment in an investigational study

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• First-line Ribociclib + endocrine therapy
Ribociclib + letrozole, or Ribociclib + anastrazole, or Ribociclib + exemestane, or Ribociclib + fulvestrant
• First-line endocrine therapy
As of physicians choice
• First-line chemtherapy
As of physicians choice

Locations

Country	Name	City	State
Germany	Novartis Investigative Site	Altoetting
Germany	Novartis Investigative Site	Altoetting	Bayern
Germany	Novartis Investigative Site	Amberg	Bayern
Germany	Novartis Investigative Site	Ansbach	Bayern
Germany	Novartis Investigative Site	Apolda	Thueringen
Germany	Novartis Investigative Site	Arnsberg Huesten	Hochsauerland
Germany	Novartis Investigative Site	Aschaffenburg	Bayern
Germany	Novartis Investigative Site	Augsburg	Bavaria
Germany	Novartis Investigative Site	Augsburg
Germany	Novartis Investigative Site	Augsburg
Germany	Novartis Investigative Site	Bad Homburg	Hessen
Germany	Novartis Investigative Site	Bad Liebenwerda
Germany	Novartis Investigative Site	Bad Nauheim	Hessen
Germany	Novartis Investigative Site	Baden-Baden	Baden-Wuerttemberg
Germany	Novartis Investigative Site	Baden-Württemberg	Heidenheim a.d.B
Germany	Novartis Investigative Site	Bamberg	Bavaria
Germany	Novartis Investigative Site	Bamberg
Germany	Novartis Investigative Site	Bayern	Donauworth
Germany	Novartis Investigative Site	Bayreuth	Bayern
Germany	Novartis Investigative Site	Bayreuth
Germany	Novartis Investigative Site	Bergisch Gladbach	Nordrhein Westfalen
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Bielefeld	Nordrhein Westfalen
Germany	Novartis Investigative Site	Bielefeld	Nordrhein Westfalen
Germany	Novartis Investigative Site	Bochum	Nordrhein-Westfalen
Germany	Novartis Investigative Site	Bochum
Germany	Novartis Investigative Site	Boeblingen
Germany	Novartis Investigative Site	Bonn
Germany	Novartis Investigative Site	Bonn
Germany	Novartis Investigative Site	Bonn	Nordrhein Westfalen
Germany	Novartis Investigative Site	Bonn	Nordrhein Westfalen
Germany	Novartis Investigative Site	Bottrop
Germany	Novartis Investigative Site	Brandenburg
Germany	Novartis Investigative Site	Brandenburg A D Havel	Brandenburg
Germany	Novartis Investigative Site	Braunschweig	Niedersachsen
Germany	Novartis Investigative Site	Bremen
Germany	Novartis Investigative Site	Bremen
Germany	Novartis Investigative Site	Bremen
Germany	Novartis Investigative Site	Bremerhaven
Germany	Novartis Investigative Site	Bremerhaven	Bremen
Germany	Novartis Investigative Site	Buchholz	Niedersachsen
Germany	Novartis Investigative Site	Celle
Germany	Novartis Investigative Site	Chemnitz
Germany	Novartis Investigative Site	Chemnitz
Germany	Novartis Investigative Site	Cottbus
Germany	Novartis Investigative Site	Damme	Niedersachsen
Germany	Novartis Investigative Site	Darmstadt	Hessen
Germany	Novartis Investigative Site	Dessau Rosslau
Germany	Novartis Investigative Site	Doberlug Kirchhain	Brandenburg
Germany	Novartis Investigative Site	Dortmund	Nordrhein-Westfalen
Germany	Novartis Investigative Site	Dortmund	Nordrhein Westfalen
Germany	Novartis Investigative Site	Dresden	Sachsen
Germany	Novartis Investigative Site	Dresden	Sachsen
Germany	Novartis Investigative Site	Dresden
Germany	Novartis Investigative Site	Duesseldorf	Nordrhein Westfalen
Germany	Novartis Investigative Site	Duesseldorf	Nordrhein Westfalen
Germany	Novartis Investigative Site	Ebersberg	Bayern
Germany	Novartis Investigative Site	Eggenfelde	Passau
Germany	Novartis Investigative Site	Eisenach	Thueringen
Germany	Novartis Investigative Site	Erbach	Hessen
Germany	Novartis Investigative Site	Erfurt	Thueringen
Germany	Novartis Investigative Site	Erfurt
Germany	Novartis Investigative Site	Erlangen
Germany	Novartis Investigative Site	Essen
Germany	Novartis Investigative Site	Esslingen
Germany	Novartis Investigative Site	Eutin
Germany	Novartis Investigative Site	Flensburg	Schleswig Flensburg
Germany	Novartis Investigative Site	Frankfurt
Germany	Novartis Investigative Site	Frankfurt
Germany	Novartis Investigative Site	Frankfurt
Germany	Novartis Investigative Site	Freiburg
Germany	Novartis Investigative Site	Freudenstadt	Baden Wuerttemberg
Germany	Novartis Investigative Site	Friedberg
Germany	Novartis Investigative Site	Friedrichshafen
Germany	Novartis Investigative Site	Fuerstenwalde	Brandenburg
Germany	Novartis Investigative Site	Gelsenkirchen	Nordrhein Westfalen
Germany	Novartis Investigative Site	Georgsmarienhuette	Niedersachsen
Germany	Novartis Investigative Site	Gera
Germany	Novartis Investigative Site	Goch
Germany	Novartis Investigative Site	Goettingen
Germany	Novartis Investigative Site	Goettingen
Germany	Novartis Investigative Site	Goslar
Germany	Novartis Investigative Site	Greifswald
Germany	Novartis Investigative Site	Gummersbach
Germany	Novartis Investigative Site	Hagen	Northrhine Westfalia
Germany	Novartis Investigative Site	Halberstadt
Germany	Novartis Investigative Site	Halle
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hameln
Germany	Novartis Investigative Site	Hameln	Niedersachsen
Germany	Novartis Investigative Site	Hanau
Germany	Novartis Investigative Site	Hannover
Germany	Novartis Investigative Site	Hannover
Germany	Novartis Investigative Site	Hannover
Germany	Novartis Investigative Site	Hannover	Niedersachsen
Germany	Novartis Investigative Site	Herdecke	Nordrhein Westfalen
Germany	Novartis Investigative Site	Herne	Nordrhein-Westfalen
Germany	Novartis Investigative Site	Hilden	Nordrhein Westfalen
Germany	Novartis Investigative Site	Hildesheim
Germany	Novartis Investigative Site	Hof
Germany	Novartis Investigative Site	Homburg
Germany	Novartis Investigative Site	Ilsede
Germany	Novartis Investigative Site	Jena
Germany	Novartis Investigative Site	Kaiserslautern
Germany	Novartis Investigative Site	Karlsruhe
Germany	Novartis Investigative Site	Karlsruhe
Germany	Novartis Investigative Site	Karlsruhe	Baden Wuerttemberg
Germany	Novartis Investigative Site	Kassel
Germany	Novartis Investigative Site	Kempten
Germany	Novartis Investigative Site	Kiel
Germany	Novartis Investigative Site	Koblenz
Germany	Novartis Investigative Site	Koeln
Germany	Novartis Investigative Site	Koeln
Germany	Novartis Investigative Site	Koeln
Germany	Novartis Investigative Site	Koeln
Germany	Novartis Investigative Site	Koeln	Nordrhein Westphalen
Germany	Novartis Investigative Site	Krefeld	Nordrhein Westfalen
Germany	Novartis Investigative Site	Kronach
Germany	Novartis Investigative Site	Krumbach
Germany	Novartis Investigative Site	Kulmbach
Germany	Novartis Investigative Site	Landshut	Bayern
Germany	Novartis Investigative Site	Langen	Hessen
Germany	Novartis Investigative Site	Lebach
Germany	Novartis Investigative Site	Leipzig
Germany	Novartis Investigative Site	Leipzig
Germany	Novartis Investigative Site	Leipzig	Sachsen
Germany	Novartis Investigative Site	Lemgo	Nordrhein Westfalen
Germany	Novartis Investigative Site	Lich	Hessen
Germany	Novartis Investigative Site	Lingen	Niedersachsen
Germany	Novartis Investigative Site	Loerrach
Germany	Novartis Investigative Site	Lohsa/Weißkollm
Germany	Novartis Investigative Site	Ludwigsfelde	Brandenburg
Germany	Novartis Investigative Site	Luebeck	Schleswig-Holstein
Germany	Novartis Investigative Site	Luebeck
Germany	Novartis Investigative Site	Magdeburg	Sachsen Anhalt
Germany	Novartis Investigative Site	Magdeburg	Sachsen Anhalt
Germany	Novartis Investigative Site	Mainz
Germany	Novartis Investigative Site	Mannheim
Germany	Novartis Investigative Site	Mannheim
Germany	Novartis Investigative Site	Mannheim	Beden Wuerttenberg
Germany	Novartis Investigative Site	Mannheim	Baden Wuerttemberg
Germany	Novartis Investigative Site	Marburg	Hessen
Germany	Novartis Investigative Site	Marburg
Germany	Novartis Investigative Site	Marktredwitz
Germany	Novartis Investigative Site	Mayen	Rheinland Pfalz
Germany	Novartis Investigative Site	Meinigen	Thueringen
Germany	Novartis Investigative Site	Memmingen
Germany	Novartis Investigative Site	Minden
Germany	Novartis Investigative Site	Moenchengladbach
Germany	Novartis Investigative Site	Moers
Germany	Novartis Investigative Site	Muehlhausen
Germany	Novartis Investigative Site	Muenchen	Bavaria
Germany	Novartis Investigative Site	Muenchen	Bayern
Germany	Novartis Investigative Site	Muenchen	Bayern
Germany	Novartis Investigative Site	Muenster
Germany	Novartis Investigative Site	Mutlangen	Baden-Wuerttemberg
Germany	Novartis Investigative Site	Naunhof
Germany	Novartis Investigative Site	Neu-Brandenburg	Brandenburg
Germany	Novartis Investigative Site	Neuruppin
Germany	Novartis Investigative Site	Neuss
Germany	Novartis Investigative Site	Neuss	Nordrhein Westfalen
Germany	Novartis Investigative Site	Neustadt	Rheinland-Pfalz
Germany	Novartis Investigative Site	Neustadt/Sachsen
Germany	Novartis Investigative Site	Nordhausen
Germany	Novartis Investigative Site	Nuernberg
Germany	Novartis Investigative Site	Nuernberg
Germany	Novartis Investigative Site	Nuernberg	Bayern
Germany	Novartis Investigative Site	Nuertingen	Baden Wuerttemberg
Germany	Novartis Investigative Site	Offenbach
Germany	Novartis Investigative Site	Offenburg
Germany	Novartis Investigative Site	Oldenburg
Germany	Novartis Investigative Site	Olpe	Nordrhein Westfalen
Germany	Novartis Investigative Site	Osnabrueck	Niedersachsen
Germany	Novartis Investigative Site	Osnabrueck
Germany	Novartis Investigative Site	Ostfildern	Baden Wurttemberg
Germany	Novartis Investigative Site	Paderborn	Nordrhein Westfalen
Germany	Novartis Investigative Site	Passau
Germany	Novartis Investigative Site	Pforzheim
Germany	Novartis Investigative Site	Pirna	Sachsen
Germany	Novartis Investigative Site	Plauen Kauschwitz
Germany	Novartis Investigative Site	Potsdam
Germany	Novartis Investigative Site	Quedlinburg	Niedersachsen
Germany	Novartis Investigative Site	Ravensburg
Germany	Novartis Investigative Site	Regensburg
Germany	Novartis Investigative Site	Regensburg	Bayern
Germany	Novartis Investigative Site	Remscheid	Nordrhein-Westfalen
Germany	Novartis Investigative Site	Remscheid Innen	Northrhine Westfalia
Germany	Novartis Investigative Site	Reutlingen	Baden Wuerttemberg
Germany	Novartis Investigative Site	Rheine
Germany	Novartis Investigative Site	Rodewisch	Sachsen
Germany	Novartis Investigative Site	Rodgau
Germany	Novartis Investigative Site	Rosenheim	Bayern
Germany	Novartis Investigative Site	Rostock	Mecklenburg Vorpommern
Germany	Novartis Investigative Site	Rostock
Germany	Novartis Investigative Site	Rostock
Germany	Novartis Investigative Site	Rotenburg
Germany	Novartis Investigative Site	Rottweil	Baden-Wuerttemberg
Germany	Novartis Investigative Site	Ruesselsheim
Germany	Novartis Investigative Site	Saarbruecken
Germany	Novartis Investigative Site	Saarlouis
Germany	Novartis Investigative Site	Salzgitter
Germany	Novartis Investigative Site	Scheibenberg	Sachsen
Germany	Novartis Investigative Site	Schkeuditz	Sachsen
Germany	Novartis Investigative Site	Schorndorf
Germany	Novartis Investigative Site	Schwaebisch	Baden-Wuerttemberg
Germany	Novartis Investigative Site	Schwaebisch Hall
Germany	Novartis Investigative Site	Schweinfurt
Germany	Novartis Investigative Site	Schwerin	Mecklenburg Vorpommern
Germany	Novartis Investigative Site	Schwerte
Germany	Novartis Investigative Site	Siegen	Nordrhein Westfalen
Germany	Novartis Investigative Site	Sigmaringen	Baden-Wuerttemberg
Germany	Novartis Investigative Site	Simmern	Rheinland Pfalz
Germany	Novartis Investigative Site	Soest
Germany	Novartis Investigative Site	Spremberg	Brandenburg
Germany	Novartis Investigative Site	Stade
Germany	Novartis Investigative Site	Stendal
Germany	Novartis Investigative Site	Stolberg
Germany	Novartis Investigative Site	Stralsund	Mecklenburg Vorpommern
Germany	Novartis Investigative Site	Straubing	Bayern
Germany	Novartis Investigative Site	Stuttgart
Germany	Novartis Investigative Site	Stuttgart
Germany	Novartis Investigative Site	Suhl
Germany	Novartis Investigative Site	Suhl	Thueringen
Germany	Novartis Investigative Site	Torgau
Germany	Novartis Investigative Site	Trier
Germany	Novartis Investigative Site	Troisdorf	Nordrhein-Westfalen
Germany	Novartis Investigative Site	Tuebingen
Germany	Novartis Investigative Site	Twistringen	Lower Saxony
Germany	Novartis Investigative Site	Ulm
Germany	Novartis Investigative Site	Ulm
Germany	Novartis Investigative Site	Vechta
Germany	Novartis Investigative Site	Velbert	North Rhine-Westphalia
Germany	Novartis Investigative Site	Voelklingen
Germany	Novartis Investigative Site	Weiden
Germany	Novartis Investigative Site	Weinheim
Germany	Novartis Investigative Site	Wesel	Nordrhein Westfalen
Germany	Novartis Investigative Site	Wesel	Nordrhein Westfalen
Germany	Novartis Investigative Site	Westerstede	Niedersachsen
Germany	Novartis Investigative Site	Wetzlar
Germany	Novartis Investigative Site	Wiesbaden
Germany	Novartis Investigative Site	Wiesbaden
Germany	Novartis Investigative Site	Wilhelmshaven
Germany	Novartis Investigative Site	Winnenden	Baden Wuerttemberg
Germany	Novartis Investigative Site	Witten	Nordrhein Westfalen
Germany	Novartis Investigative Site	Wolfenbuettel	Niedersachsen
Germany	Novartis Investigative Site	Wolfsburg
Germany	Novartis Investigative Site	Worms
Germany	Novartis Investigative Site	Wuerselen
Germany	Novartis Investigative Site	Wuerzburg
Germany	Novartis Investigative Site	Wuerzburg	Bayern
Germany	Novartis Investigative Site	Zittau	Sachsen
Germany	Novartis Investigative Site	Zxickau	Sachsen

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival (PFS)	Progression-free survival was defined as first intake of study medication in current-line therapy up to first documented progress or death from any cause in this treatment line. If a patient had not had an event, progression-free survival was censored at the end of the respective therapy line.	Up to 88 months
Secondary	Cox proportional hazard regression for progression free survival in 1st line therapy	Cox proportional hazard regression were calculated with the covariates treatment cohort, age group, previous therapy, ECOG performance status, grading status and metastasis status for the full analysis set excluding patients with missing data in covariates.	Up to 88 months
Secondary	Propensity Score matching for progression free survival in 1st line therapy	Propensity score matching (PSM) was performed to compare outcome between cohorts and performed separately for the Ribociclib+AI/FU vs. Chemotherapy cohort resp. the Ribociclib+AI/FU vs. Endocrine therapy cohort in a 5:1 ratio.	Up to 88 months
Secondary	Sequential progression-free survival (PFS_S)	Sequential progression-free survival up to second-line therapy was defined as time between first intake of study medication in first-line therapy up to progress or death after second-line therapy. Sequential progression-free survival up to third-line therapy was defined as time between first intake of study medication in first-line therapy up to progress or death after third-line therapy. Sequential progression-free survival for all further therapy lines were analyzed according to the definitions above.	Up to 88 months
Secondary	Conditional progression-free survival	Conditional progression-free survival in first-line therapy was defined as PFS for patients with a period of up to 6, 12, or 24 months from start of study treatment (first intake) up to first progression.; This means that all patients with progression or death within the first 24 months of first-line therapy are classified into one of the three subgroups: Progression in month 0 to 6, Progression in month 7 to 12 and Progression in month 13 to 24. For these subgroups, the PFS is presented separately.	Up to 88 months
Secondary	Time to treatment failure (TTF)	Time to treatment failure (TTF) from current-line therapy was defined as time between first intake of study medication in current-line therapy up to therapy discontinuation because of progress, adverse events leading to discontinuation or death.	Up to 88 months
Secondary	Time to first chemotherapy	Time to first chemotherapy was defined as time between first intake of study medication in first-line therapy up to first application of chemotherapy for patients enrolled in 1st line option ribociclib + AI/FU or endocrine therapy.	Up to 88 months
Secondary	Time to next treatment / therapy (TTNT) after 1st line treatment	Time to next treatment / therapy (TTNT) was defined as time between first intake of study medication in first-line therapy up to first intake of medication in the next therapy line.	Up to 88 months
Secondary	Overall survival (OS)	Overall survival (OS) was defined as time between first intake of study medication in first-line therapy up to death from any cause. If a patient was not known to have died, survival was censored at the date of last contact.	Up to 88 months
Secondary	Dose reduction	Dose reduction rates and reasons	Up to 88 months
Secondary	Dose interruption	Dose interruption rates and reasons	Up to 88 months
Secondary	Discontinuations	Discontinuations rates and reasons	Up to 88 months
Secondary	Adherence - MMAS-8 questionnaire	Patient adherence for ribociclib was assessed using the MMAS-8 questionnaire. This questionnaire was only send to patients enrolled in the first-line option ribociclib + AI/FU. The score was analyzed using descriptive statistics and adherence categories low, medium and high were displayed by visit. Questionnaires were only included if all questionnaire items were answered.; The total scale has a range of 0 to 8.0 where: Low Adherence (< 6); Medium Adherence (6 to <8); High Adherence (= 8)	Up to 87 weeks
Secondary	Number of participants with mutations	Number of participants with mutations will be collected	Up to 88 months
Secondary	Quality of life for specific cohorts and treatment lines - EORTC QLQ-C30	Quality of life during documented therapy lines was assessed using the EORTC QLQ-C30. Scale and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.	Up to 88 months
Secondary	Quality of life for specific cohorts and treatment lines - EORTC QLQ-B23	Quality of life during documented therapy lines was assessed using the EORTC QLQ-C30. Scale and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.	Up to 88 months
Secondary	Quality of life for specific cohorts and treatment lines - HADS-D	Quality of life during documented therapy lines was assessed using the HADS-D. Scale ranges between 0 and 21, a high score means a high level of anxiety or depression.	Up to 88 months