Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

ribociclib (600 mg, 3 weeks on/1 week off)+ IA/FUL + goserilin for premenopausal patients

The choice of which chemotherapy combination used on study is decided by the physician

There is no treatment allocation. Participants with HR+HER2- aBC that initiated treatment with ribociclib+ET by prescription within the study enrollment timeline will be recruited.

Ribociclib

There is no treatment allocation. Participants with HR+HER2- aBC that initiated treatment with CT by prescription within the study enrollment timeline will be recruited.

Combination chemotherapy

Novartis Pharmaceuticals

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.

Patients with HR+HER2- advanced breast cancer that initiated treatment with ribociclib+ET or combination CT will be enrolled. Approximately, 188 patients will be included into each treatment cohort of the study across different study sites in the Russian Federation and will be assigned to one of the below treatment arms:

* Ribociclib arm: ribociclib (600 mg, 3 weeks on/1 week off)+ IA/FUL + goserilin for premenopausal patients (N = 188)
* Combination chemotherapy arm: physician's choice (N = 188) The study will consist of pre-index period, index date and follow up period. Retrospective data will be collected as such: Medical history, previous treatment for Breast cancer (neoad'uvant and ad'uvant if applicable).In this study an index date is defined as a start of ribociclib+ET or chemotherapy treatment. Post-index follow-up period is 24 months or Progressive disease.

Patients will attend 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. No additional diagnostic or monitoring procedures will be applied to the patients and epidemiological methods shall be used for the analysis of collected data. Available data from routine clinical management of the patients will be collected at patients' visits to the clinical site. Patients enrolled in the study will be followed up until death or study close whichever occurs first.

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

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

The primary efficacy endpoint of the study is time to treatment failure (TTF) in in RIB + ET (AI/FUL) and combination chemotherapy cohorts. Time to treatment failure (TTF) is defined as the time from initiation of treatment to discontinuation of treatment for any reason, including disease progression, treatment toxicity, and death.

Number of participants premenopausal, perimenopausal ad postmenopausal at baseline.

Number of participants by HER2 status (HER2 receptor positive/negative)

Number of participants by tumor, nodes and metastasis (TNM) stage

Percentage of patients receiving different combination chemotherapy regimens.

Time to treatment failure in HR+HER2- aBC patients in RIB+ET and combination chemotherapy cohorts (in the subgroups Disease-free interval (DFI) ≤ 12 month, DFI \> 12 month, Pre- and post menopause).

Disease-free interval (DFI) will be calculated as the time from the date of diagnosis until the date of first recurrence/progression.

Objective response rate (ORR) as assessed by the investigator. Objective response rate (ORR) is the proportion of patients with a best overall response of Complete Response or Partial Response.

Clinical benefit rate (CBR) as assessed by the investigator. Clinical benefit rate (CBR) is the proportion of patients with a best overall response of Complete Response (CR) or Partial Response (PR) , or an overall lesion response of Stable Disease or Non-CR/Non-PD which lasts for a minimum time duration (with a default of at least 24 weeks in breast cancer studies).

Time to onset of response (TTR) as assessed by the investigator. Time to onset of response (TTR) is defined as the time from the date of randomization to the first documented response of either CR or PR, which must be subsequently confirmed (although date of initial response is used, not date of confirmation). CR and PR are based on tumor response data as per local review.

Quality of life (EQ-5D-5L) during treatment with ribociclib + ET (AI/FUL) and combination chemotherapy is measured, if used in real practice.

The scale measures quality of life on a 5-component scale: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Prospective NIS to Evaluate the Clinical Outcomes of Risarg® (Ribociclib) Combined With Endocrine Therapy or Chemotherapy in Patients With HR+HER2 - aBC in Routine Clinical Practice in the Russia	NCT06148506	HR+HER2- Advanc...	Ribociclib Combination che...	18 Years - 99 Years	Novartis
A Prospective NIS to Evaluate the Clinical Outcomes of Risarg® (Ribociclib) Combined With Endocrine Therapy or Chemotherapy in Patients With HR+HER2 - aBC in Routine Clinical Practice in the Russia	NCT06148506	HR+HER2- Advanc...	Ribociclib Combination che...	18 Years - 99 Years	Novartis

Spots Global Cancer Trial Database for ribociclib+et,