Trial Title:
A Prospective NIS to Evaluate the Clinical Outcomes of Risarg® (Ribociclib) Combined With Endocrine Therapy or Chemotherapy in Patients With HR+HER2 - aBC in Routine Clinical Practice in the Russia
NCT ID:
NCT06148506
Condition:
HR+HER2- Advanced Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
HR+HER2- advanced breast cancer,
ribociclib+ET,
Chemotherapy
ribociclib
NIS
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Ribociclib
Description:
There is no treatment allocation. Participants with HR+HER2- aBC that initiated treatment
with ribociclib+ET by prescription within the study enrollment timeline will be
recruited.
Arm group label:
Ribociclib Arm
Other name:
Risarg
Intervention type:
Other
Intervention name:
Combination chemotherapy
Description:
There is no treatment allocation. Participants with HR+HER2- aBC that initiated treatment
with CT by prescription within the study enrollment timeline will be recruited.
Arm group label:
Combination chemotherapy
Summary:
This is а prospective, non-interventional, primary data collection cohort study to
evaluate the clinical outcomes of the combination of ribociclib + ET and combination
chemotherapy in the real-life setting in Russia. This study is observational in nature;
it does not impose a therapy, diagnostic/therapeutic interventions or a visit schedule.
Detailed description:
Patients with HR+HER2- advanced breast cancer that initiated treatment with ribociclib+ET
or combination CT will be enrolled. Approximately, 188 patients will be included into
each treatment cohort of the study across different study sites in the Russian Federation
and will be assigned to one of the below treatment arms:
- Ribociclib arm: ribociclib (600 mg, 3 weeks on/1 week off)+ IA/FUL + goserilin for
premenopausal patients (N = 188)
- Combination chemotherapy arm: physician's choice (N = 188) The study will consist of
pre-index period, index date and follow up period. Retrospective data will be
collected as such: Medical history, previous treatment for Breast cancer
(neoad'uvant and ad'uvant if applicable).In this study an index date is defined as a
start of ribociclib+ET or chemotherapy treatment. Post-index follow-up period is 24
months or Progressive disease.
Patients will attend the sites in accordance with routine clinical practice. It is
assumed according to the clinical practice that visits will be conducted every 3-4
months. Patients will undergo standard procedures and tests according to clinical
guidelines and physician's judgement. No additional diagnostic or monitoring procedures
will be applied to the patients and epidemiological methods shall be used for the
analysis of collected data. Available data from routine clinical management of the
patients will be collected at patients' visits to the clinical site. Patients enrolled in
the study will be followed up until death or study close whichever occurs first.
Criteria for eligibility:
Study pop:
Patients with HR+HER2- advanced breast cancer that initiated treatment with ribociclib+ET
or combination CT will be enrolled
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
1. Age ≥ 18 years at the moment of ribociclib+ET or CT initiation.
2. Female/Male gender.
3. Luminal A, Luminal B subtype.
4. Patients with ECOG performance status ≤ 2.
5. Confirmed diagnosis of locally advanced/metastatic not eligible to surgery HR+HER2-
BC (de novo) for whom the treating physician took the decision to initiate treatment
with ribociclib+IA/FUL or combination chemotherapy before entering the study in the
first line of the treatment.
6. Multiple visceral metastases (including stable CNS mts).
7. Pre-/Pere /postmenopause.
8. Patient who initiated treatment with ribociclib+IA/FUL or combination chemotherapy
no longer than 4 weeks (28 days) prior to written informed consent for this study.
Exclusion Criteria:
1. Patients with a life expectancy of less than 3 months per the investigator's
judgment.
2. Patients participating in any interventional clinical trial that includes
investigational or marketed products at the time of enrollment. (Patients
participating in other investigator initiated research or NIS can be included as
long as their standard of care is not altered by the study).
3. Patients on active treatment for malignancies other than aBC at the time of
enrollment.
4. Patients who are unable to understand the nature of the study and are unwilling to
sign an informed consent.
5. Patients with visceral crisis (according to ABC5 definition*) *Visceral crisis is
defined as severe organ dysfunction, as assessed by signs and symptoms, laboratory
studies and rapid progression of disease. Visceral crisis is not the mere presence
of visceral metastases but implies important organ compromise leading to a clinical
indication for the most rapidly efficacious therapy [8].
Examples: Liver visceral crisis: rapidly increasing bilirubin >1.5 ULN in the absence of
Gilbert's syndrome or biliary tract obstruction. Lung visceral crisis: rapidly increasing
dyspnoea at rest, not alleviated by drainage of pleural effusion
Gender:
All
Minimum age:
18 Years
Maximum age:
99 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Novartis Investigative Site
Address:
City:
Barnaul
Zip:
656045
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Chelyabinsk
Zip:
454087
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Ekaterinburg
Zip:
620036
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Irkutsk
Zip:
664035
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Izhevsk
Zip:
426009
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Kaluga
Zip:
248007
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Krasnodar
Zip:
350040
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Krasnoyarsk
Zip:
660022
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Moscow Region Istra Village
Zip:
143423
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Moscow
Zip:
115304
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Moscow
Zip:
115478
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Nalchik
Zip:
360051
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Podolsk
Zip:
142110
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Saransk
Zip:
430032
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Tambov
Zip:
392000
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Tver
Zip:
170008
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Ufa
Zip:
450054
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Vladikavkaz
Zip:
362002
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Yaroslavl
Zip:
150054
Country:
Russian Federation
Status:
Recruiting
Start date:
December 28, 2023
Completion date:
June 30, 2027
Lead sponsor:
Agency:
Novartis Pharmaceuticals
Agency class:
Industry
Source:
Novartis
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06148506
