A Prospective Non-interventional Study to Evaluate Clinical Outcomes of Ribociclib Combined With Endocrine Therapy in Elderly Patients With HR+HER2 - Advanced Breast Cancer in Routine Clinical Practice in Russian Federation (PARFENOPA)

This is а prospective, non-interventional, primary data collection study to evaluate the effectiveness, safety and quality of life in older patients (≥65 years) with HR+HER2- advanced breast cancer receiving ribociclib with ET in the first or second line in the real-life settings in Russia.

Study Overview

• Status: Active, not recruiting
• Conditions: HR+HER2- Advanced Breast Cancer

Detailed Description

In this study, an index event is a start of ribociclib+ET treatment. Post-index follow-up period is 24 months or until treatment discontinuation. The recruitment period is planned for 12 months. The interim analyses will be performed after enrollment is complete, and further one year later. Patients will visit 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.

• Study Type: Observational
• Enrollment (Actual): 329

Contacts and Locations

Study Locations

• Russia
  • Arkhangelsk, Russia, 163045
    • Novartis Investigative Site
  • Barnaul, Russia, 656045
    • Novartis Investigative Site
  • Bryansk, Russia, 241028
    • Novartis Investigative Site
  • Chelyabinsk, Russia, 454080
    • Novartis Investigative Site
  • Irkutsk, Russia, 664035
    • Novartis Investigative Site
  • Kemerovo, Russia, 650036
    • Novartis Investigative Site
  • Khabarovsk, Russia, 680042
    • Novartis Investigative Site
  • Khanty-Mansiysk, Russia, 628012
    • Novartis Investigative Site
  • Kirov, Russia, 610021
    • Novartis Investigative Site
  • Krasnoyarsk, Russia, 660022
    • Novartis Investigative Site
  • Obninsk, Russia, 249036
    • Novartis Investigative Site
  • Perm, Russia, 614066
    • Novartis Investigative Site
  • Rostov-on-Don, Russia, 344006
    • Novartis Investigative Site
  • Saint Petersburg, Russia, 197758
    • Novartis Investigative Site
  • Saint Petersburg, Russia, 194291
    • Novartis Investigative Site
  • Tambov, Russia, 392000
    • Novartis Investigative Site
  • Tver', Russia, 170008
    • Novartis Investigative Site
  • Ufa, Russia, 450054
    • Novartis Investigative Site
  • Yaroslavl, Russia, 150054
    • Novartis Investigative Site
  • Yekaterinburg, Russia, 620036
    • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

elderly patients with HR+HER2- advanced breast cancer

Description

Inclusion Criteria:

1. Age ≥ 65 years at the moment of ribociclib+ET initiation
2. Female/Male gender
3. Confirmed diagnosis of locally advanced/metastatic not eligible for curative surgery HR+HER2- BC for whom the treating physician took the decision to initiate treatment with ribociclib+IA/FUL in the first or in the second line of the treatment
4. Patient who initiated treatment with ribociclib+IA/FUL no longer than 4 weeks (28 days) prior to written informed consent for this study
5. Provision of written informed consent.

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 within 3 years before BC diagnosis
4. Patients with active cardiac disease, or history of cardiac dysfunction, including prolonged QT interval corrected using Fridericia's formula (QTcF > 450 msec).

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change of QoL (RAND SF-36)	The primary endpoint of the study is the change of QoL during treatment with ribociclib+ET from baseline to the level at 12 months (RAND SF-36) across all age's subgroups (ages 65 to 74 years; middle-old, 75 to 84 years; and oldest-old, ≥85 years) and depend on treatment lines (first-line (1L) or in second-line (2L) settings)	from baseline to the level at 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to treatment failure (TTF)	Time to treatment failure (TTF) in HR+/HER2- aBC women initiating treatment with ribociclib+ET across all age subgroups (ages 65 to 74 years; middle-old, 75 to 84 years; and oldest-old, ≥85 years) depend on treatment lines (1L or 2L)	up to two years
Progression free survival rate (PFS)	Progression free survival rate (PFS) at 24 months in HR+/HER2- aBC women initiating treatment with ribociclib+ET across all age subgroups (ages 65 to 74 years; middle-old, 75 to 84 years; and oldest-old, ≥85 years) depend on treatment lines (1L or 2L)	up to two years
Median progression free survival	Median progression free survival (if reached) in HR+/HER2- aBC women initiating treatment with ribociclib+ET across all age subgroups (ages 65 to 74 years; middle-old, 75 to 84 years; and oldest-old, ≥85 years) depend on treatment lines (1L or 2L)	up tp two years
Overall survival rate (OS)	Overall survival rate (OS) at 24 months in HR+/HER2- aBC women initiating treatment with ribociclib+ET in across all age subgroups (ages 65 to 74 years; middle-old, 75 to 84 years; and oldest-old, ≥85 years) depend on treatment lines (1L or 2L)	up to two years
Objective response rate (ORR)	Objective response rate (ORR) as assessed by the investigator in HR+/HER2- aBC women initiating treatment with ribociclib+ET across all age subgroups (ages 65 to 74 years; middle-old, 75 to 84 years; and oldest-old, ≥85 years) depend on treatment lines (1L or 2L)	up to two years
Clinical benefit rate (CBR)	Clinical benefit rate (CBR) as assessed by the investigator in HR+/HER2- aBC women initiating treatment with ribociclib+ET across all age subgroups (ages 65 to 74 years; middle-old, 75 to 84 years; and oldest-old, ≥85 years) depend on treatment lines (1L or 2L).	up to two years
Proportions (%) of patients and reasons of permanent discontinuation of ribociclib	Proportions (%) of patients and reasons of permanent discontinuation of ribociclib	up to two years
Proportions (%) of patients and reasons of dose adjustment on ribocicli	Proportions (%) of patients and reasons of dose adjustment on ribocicli	up to two years
Adverse events (AEs) frequency and severity	Adverse events (AEs) frequency and severity	up to two years
Quality of life (RAND SF-36, questionnaire of patient's satisfaction)	Quality of life (RAND SF-36, questionnaire of patient's satisfaction) during treatment with ribociclib + ET (AI/FUL) across all age subgroups (ages 65 to 74 years; middle-old, 75 to 84 years; and oldest-old, ≥85 years) and in first-line (1L) and in second-line (2L) settings	up to two years

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: October 2, 2024
• First Submitted That Met QC Criteria: October 2, 2024
• First Posted (Actual): October 3, 2024

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: HR+HER2- advanced breast cancer, ribociclib, elderly patients
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: CLEE011ARU06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No