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NCT Number: NCT06625333

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

HR+HER2- Advanced Breast Cancer

Age range

65 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigative Site, Arkhangelsk, Russia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 65 years at the moment of ribociclib+ET initiation
  • Female/Male gender
  • 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
  • Patient who initiated treatment with ribociclib+IA/FUL no longer than 4 weeks (28 days) prior to written informed consent for this study
  • Provision of written informed consent.

Exclusion criteria

  • Patients with a life expectancy of less than 3 months per the investigator's judgment
  • 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)
  • Patients on active treatment for malignancies other than aBC within 3 years before BC diagnosis
  • Patients with active cardiac disease, or history of cardiac dysfunction, including prolonged QT interval corrected using Fridericia's formula (QTcF > 450 msec).

Treatment and study plan

Primary outcomes

  1. change of QoL (RAND SF-36)

    Time frame: from baseline to the level at 12 months

    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)

Secondary outcomes

  1. Time to treatment failure (TTF)

    Time frame: up to two years

    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)

  2. Progression free survival rate (PFS)

    Time frame: up to two years

    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)

  3. Median progression free survival

    Time frame: up tp two years

    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)

  4. Overall survival rate (OS)

    Time frame: up to two years

    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)

  5. Objective response rate (ORR)

    Time frame: up to two years

    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)

  6. Clinical benefit rate (CBR)

    Time frame: up to two years

    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).

  7. Proportions (%) of patients and reasons of permanent discontinuation of ribociclib

    Time frame: up to two years

    Proportions (%) of patients and reasons of permanent discontinuation of ribociclib

  8. Proportions (%) of patients and reasons of dose adjustment on ribocicli

    Time frame: up to two years

    Proportions (%) of patients and reasons of dose adjustment on ribocicli

  9. Adverse events (AEs) frequency and severity

    Time frame: up to two years

    Adverse events (AEs) frequency and severity

  10. Quality of life (RAND SF-36, questionnaire of patient's satisfaction)

    Time frame: up to two years

    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

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Acronym: PARFENOPA

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Oct 3, 2024
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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