Non-interventional Study to Assess the Effectiveness and Safety of Ribociclib in the Adjuvant Therapy of Hormone Receptor Positive (HR+) HER2-negative Stage II and III Breast Cancer in Real Clinical Practice in Russia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ribociclib, Letrozole, Anastrozole.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Russia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
This prospective, observational, multicenter study aims at evaluating the efficacy of adjuvant ribociclib in combination with hormone therapy (aromatase inhibitor ± GnRH aginost) in various subgroups of patients with HR+HER2- stage II-III breast cancer in real clinical practice in Russia. Subgroup division will be based on the tumor grade, lymph node involvement, and the response to test hormone therapy. The study will consist of two cohorts: a prospective one with patients receiving adjuvant therapy with ribociclib combined with Aromatase inhibitors (AI), and a retrospective one with patients receiving adjuvant therapy with AI alone. Thus, both primary data collection and secondary use of data will be organized.
Interventions
- Drug Ribociclib
CDK4/6 inhibitor - Drug Letrozole
Aromatase inhibitor - Drug Anastrozole
Aromatase inhibitor
Primary outcome measures
- Invasive breast cancer-free survival (IBCFS) according to the Standardized Definitions for Efficacy End Points (STEEP) criteria in a prospective cohort [Time frame: Months 36, 48, 60]
Secondary outcome measures (7)
- Invasive breast cancer-free survival in prospective and retrospective cohorts depending on the tumor grade (G2/G3) and on the status of lymph nodes involvement (N0/N1/N2-3). [Time frame: Months 36, 48, 60]
- Invasive disease-free survival (IDFS) in prospective and retrospective cohorts depending on the tumor grade (G2/G3) and on the status of lymph nodes involvement (N0/N1/N2-3). [Time frame: Months 36, 48, 60]
- Recurrence-free survival (RFS) in the prospective and retrospective cohorts depending on the tumor grade (G2/G3) and on the status of lymph nodes involvement (N0/N1/N2-3). [Time frame: Months 36, 48, 60]
- Number of doses taken relative to the total planned doses of ribociclib % [Time frame: Months 36]
- Number of participants with AEs/SAEs including those of special interest, in patients receiving ribociclib [Time frame: Months 3, 6, 9, 12, 24, 36]
- Number of patients who discontinued ribociclib for any reason, due to any AE, and due to AEs of special interest [Time frame: Months 3, 6, 9, 12, 24, 36]
- Patients' quality of life evaluated through a questionnaire [Time frame: Months 3, 6, 9, 12, 24, 36, 48, 60]
Eligibility criteria
Inclusion criteria
Patients from the prospective cohort of the study must meet all of the following criteria:
- Signed and dated Informed Consent Form (ICF) not later than 28 days after the initiation of adjuvant therapy with ribociclib in combination with aromatase inhibitors (±GnRH agonists).
- Age ≥18 years at the time of signing the ICF.
- Histologically verified HR+ HER2-negative stage II-III breast cancer, for which radical treatment was carried out.
- The adjuvant hormone therapy with aromatase inhibitors (±GnRH agonists) may be started not earlier than 12 months before initiation of therapy with ribociclib.
- ECOG performance status 0-1
Patients from the retrospective cohort of the study must meet all of the following criteria:
- Age ≥18 years at the initiation of hormone therapy.
- Histologically verified HR+ HER2-negative stage II-III breast cancer, for which radical treatment was carried out.
- Initiation of adjuvant hormone monotherapy with aromatase inhibitors (±GnRH agonists) in the index period from July 1, 2019 to July 1, 2020.
- Presence of the necessary information in the source documentation.
Exclusion criteria
Patients enrolled in the study in prospective cohort should not meet any of the following criteria.
- History of therapy with abemaciclib or palbociclib
- Therapy with ribociclib in combination with AI for more than 28 days at the time of signing the Informed Consent Form
- Active therapy for other malignant neoplasms
- Participation in interventional clinical studies at the time of signing the Informed Consent Form
Patients enrolled in the study in retrospective cohort should not meet any of the following criteria.
- Neoadjuvant or adjuvant therapy with CDK4/6 inhibitors
- A history of another concomitant malignant neoplasm requiring active therapy
- Participation in interventional clinical studies at the time of treatment for breast cancer
- Patients experiencing a recurrence during adjuvant hormone therapy can participate if they meet the other inclusion and exclusion criteria.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Russia · 40 centers
- Novartis Investigative Site — Kaluga
- Novartis Investigative Site — Pskov
- Novartis Investigative Site — Ryazan
- Novartis Investigative Site — Saint Petersburg
- Novartis Investigative Site — Surgut
- Novartis Investigative Site — Arkhangelsk
- Novartis Investigative Site — Barnaul
- Novartis Investigative Site — Bryansk
- … and 32 more centers
Identifiers
NCT: NCT06930859 · CLEE011O1RU02