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HR+HER2- Advanced Breast CancerPARFENOPANCT06625333

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

An observational study of HR+HER2- Advanced Breast Cancer, run by Novartis Pharmaceuticals at 20 sites in Russia.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 65 to 99 years
Conditions the study is for
HR+HER2- Advanced Breast Cancer
How many people
329 participants
Where
20 sitesRussia
Study dates
11 Oct 2024to 31 Dec 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 to 99 years
  • All sexes
  • No healthy volunteers
  • Older adult

Study population: elderly patients with HR+HER2- advanced breast cancer

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

Russia20 sites

  • Novartis Investigative Site

    Arkhangelsk, 163045

  • Novartis Investigative Site

    Barnaul, 656045

  • Novartis Investigative Site

    Bryansk, 241028

  • Novartis Investigative Site

    Chelyabinsk, 454080

  • Novartis Investigative Site

    Irkutsk, 664035

  • Novartis Investigative Site

    Kemerovo, 650036

  • Novartis Investigative Site

    Khabarovsk, 680042

  • Novartis Investigative Site

    Khanty-Mansiysk, 628012

  • Novartis Investigative Site

    Kirov, 610021

  • Novartis Investigative Site

    Krasnoyarsk, 660022

  • Novartis Investigative Site

    Obninsk, 249036

  • Novartis Investigative Site

    Perm, 614066

  • Novartis Investigative Site

    Rostov-on-Don, 344006

  • Novartis Investigative Site

    Saint Petersburg, 194291

  • Novartis Investigative Site

    Saint Petersburg, 197758

  • Novartis Investigative Site

    Tambov, 392000

  • Novartis Investigative Site

    Tver', 170008

  • Novartis Investigative Site

    Ufa, 450054

  • Novartis Investigative Site

    Yaroslavl, 150054

  • Novartis Investigative Site

    Yekaterinburg, 620036

Other trials in Russia

About this study

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.

Read the 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.

Keywords
HR+HER2- advanced breast cancer, ribociclib, elderly patients

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: from baseline to the level at 12 months

Secondary outcomes (10)

  1. 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)

    Measured: up to two years

  2. 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)

    Measured: up to two years

  3. 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)

    Measured: up tp two years

  4. 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)

    Measured: up to two years

  5. 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)

    Measured: up to two years

  6. 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).

    Measured: up to two years

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

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

    Measured: up to two years

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

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

    Measured: up to two years

  9. Adverse events (AEs) frequency and severity

    Adverse events (AEs) frequency and severity

    Measured: up to two years

  10. 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

    Measured: up to two years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2024
  2. Study start11 Oct 2024
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
329 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06625333
Sponsor's protocol ID
CLEE011ARU06
Acronym
PARFENOPA
Status last verified
Mar 2026
First submitted
2 Oct 2024
Last updated
1 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of HR+HER2- Advanced Breast Cancer, run by Novartis Pharmaceuticals at 20 sites in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

change of QoL (RAND SF-36) (time frame: from baseline to the level at 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06625333.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.

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