A Prospective NIS to Evaluate the Clinical Outcomes of Risarg® (Ribociclib) Combined With Endocrine Therapy or Chemotherapy in Patients With HR+HER2 - Advanced Breast Cancer in Routine Clinical Practice in the Russian Federation

Status: Recruiting
Location: See all (21) locations...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

• Age ≥ 18 years at the moment of ribociclib+ET or CT initiation.

• Female/Male gender.

• Luminal A, Luminal B subtype.

• Patients with ECOG performance status ≤ 2.

• 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.

• Multiple visceral metastases (including stable CNS mts).

• Pre-/Pere /postmenopause.

• 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.

Locations
Other Locations
Russian Federation
Novartis Investigative Site
RECRUITING
Barnaul
Novartis Investigative Site
RECRUITING
Chelyabinsk
Novartis Investigative Site
RECRUITING
Irkutsk
Novartis Investigative Site
RECRUITING
Izhevsk
Novartis Investigative Site
RECRUITING
Kaluga
Novartis Investigative Site
RECRUITING
Kemerovo
Novartis Investigative Site
RECRUITING
Krasnodar
Novartis Investigative Site
RECRUITING
Krasnoyarsk
Novartis Investigative Site
RECRUITING
Moscow
Novartis Investigative Site
RECRUITING
Moscow
Novartis Investigative Site
RECRUITING
Moscow
Novartis Investigative Site
RECRUITING
Moscow Region Istra Village
Novartis Investigative Site
RECRUITING
Nal'chik
Novartis Investigative Site
RECRUITING
Podolsk
Novartis Investigative Site
RECRUITING
Saransk
Novartis Investigative Site
RECRUITING
Tambov
Novartis Investigative Site
RECRUITING
Tver'
Novartis Investigative Site
RECRUITING
Ufa
Novartis Investigative Site
RECRUITING
Vladikavkaz
Novartis Investigative Site
RECRUITING
Yaroslavl
Novartis Investigative Site
RECRUITING
Yekaterinburg
Contact Information
Primary
Novartis Pharmaceuticals
novartis.email@novartis.com
+41613241111
Backup
Novartis Pharmaceuticals
Time Frame
Start Date: 2023-12-28
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 376
Treatments
Ribociclib Arm
ribociclib (600 mg, 3 weeks on/1 week off)+ IA/FUL + goserilin for premenopausal patients
Combination chemotherapy
The choice of which chemotherapy combination used on study is decided by the physician
Related Therapeutic Areas
Sponsors
Leads: Novartis Pharmaceuticals

This content was sourced from clinicaltrials.gov

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