Clinical trial NCT04943497: A Prospective Observational Study to Describe Clinical Outcomes, Treatment Patterns, Patients Characteristics Among Patients With HR+/HER2- Advanced BC Initiating Treatment With Risarg®, Piqray®, Endocrine Therapy or Chemotherapy in Routine Clinical Practice in Russia
Official title: A Prospective Observational Study to Describe Clinical Outcomes, Treatment Patterns, Patients Characteristics Among Patients With HR+/HER2- Advanced BC Initiating Treatment With Risarg® (Ribociclib), Piqray® (Alpelisib), Endocrine Therapy or Chemotherapy in Routine Clinical Practice in Russia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Keywords: Breast Cancer
CDK4/6 inhibitors
advanced HR+/HER2- breast cancer
ribociclib
Risarg
alpelisib
Piqray
Russia
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2021-06-29
Enrollment: 3290
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with HR+/ HER2- advanced or metastatic BC that initiated treatment with ribociclib, alpelisib, monoET or CT within the study enrollment timeline will be provided by national oncology centers and hospitals that will be selected based on their experience in treating Breast Cancer.

Brief summary: This study is planned as a prospective multicenter NIS. This study is observational in nature and does not impose a therapy protocol, diagnostic/therapeutic interventions or a visit schedule. Patients with HR+/ HER2- advanced or metastatic BC that initiated treatment with ribociclib, alpelisib, mono endocrine therapy or chemotherapy will be included into the study across seven Russian districts.

Detailed description: Patients will attend the sites in accordance with routine clinical practice. It is assumed that visits will be conducted every 3-4 months. Patients will undergo standard procedures and tests according to clinical guidelines and physician's judgement. 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. The recruitment period is planned for 24 months, observation period for maximum of 24 months, with total duration of study 4 years. Patients may discontinue from this NIS at any time.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years at the moment of ribociclib, alpelisib, monoET or CT treatment initiation.
2. Female gender.
3. Confirmed diagnosis of locally advanced/metastatic not amenable to surgery HR+/HER2- BC (progressed following prior therapy or de novo) for whom the treating physicial took the decision to initiate treatment with ribociclib, alpelisib, monoET or CT before entering the study.
4. Patient who initiated treatment with ribociclib, alpelisib, monoET or CT no longer than 4 weeks (28 days) prior to written informed consent for this study.
5. Patients with ECOG performance status ≤ 2.
6. Provision of written informed consent.

Exclusion Criteria:

1. Patients with a life expectancy of less than 3 months at the time of aBC diagnosis 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 trial or NIS can be included as long as their standard of care is not altered by the study).
3. Patients receiving active treatment for malignancies other than BC at the time of enrollment.
4. Patients who are unable to understand the nature of the study.

Primary outcomes:
measure: Time to treatment failure (TTF)
timeFrame: Up to 24 months
Secondary outcomes:
measure: Line of treatment
timeFrame: Baseline
measure: ECOG status
timeFrame: Up to 24 months
measure: Location of metastases
timeFrame: Baseline
measure: Menopausal status
timeFrame: Baseline
measure: Number of patients with comorbidities
timeFrame: Baseline
measure: PIK3CA mutation status
timeFrame: Baseline
measure: Proportions of patients by treatment pattern
timeFrame: Up to 24 months
measure: Proportions (%) of patients by treatment sequence
timeFrame: Up to 24 months
measure: Progression free survival (PFS)
timeFrame: Up to 24 months
measure: Overall survival (OS)
timeFrame: Up to 24 months
measure: Time to chemotherapy (TTC)
timeFrame: Up to 24 months
measure: Proportion (%) of patients with permanent discontinuation
timeFrame: Up to 24 months
measure: Reasons of permanent discontinuation
timeFrame: Up to 24 months
measure: Proportion (%) of patients with dose adjustment
timeFrame: Up to 24 months
measure: Reasons of dose adjustment
timeFrame: Up to 24 months
measure: Quality of life (EORTC QLQ-C30)
timeFrame: Baseline
measure: Quality of life (EQ-5D-5L)
timeFrame: Baseline
Other outcomes:
Locations:
city: Syktyvkar
country: Russian Federation
facility: Novartis Investigative Site
state: Komi Republic
city: Surgut
country: Russian Federation
facility: Novartis Investigative Site
state: Tymen Area
city: Arkhangelsk
country: Russian Federation
facility: Novartis Investigative Site
city: Barnaul
country: Russian Federation
facility: Novartis Investigative Site
city: Belgorod
country: Russian Federation
facility: Novartis Investigative Site
city: Bryansk
country: Russian Federation
facility: Novartis Investigative Site
city: Cheboksary
country: Russian Federation
facility: Novartis Investigative Site
city: Chelyabinsk
country: Russian Federation
facility: Novartis Investigative Site
city: Ekaterinburg
country: Russian Federation
facility: Novartis Investigative Site
city: Ekaterinburg
country: Russian Federation
facility: Novartis Investigative Site
city: Irkutsk
country: Russian Federation
facility: Novartis Investigative Site
city: Ivanovo
country: Russian Federation
facility: Novartis Investigative Site
city: Kaluga
country: Russian Federation
facility: Novartis Investigative Site
city: Khabarovsk
country: Russian Federation
facility: Novartis Investigative Site
city: Khanty-Mansiysk
country: Russian Federation
facility: Novartis Investigative Site
city: Kostroma
country: Russian Federation
facility: Novartis Investigative Site
city: Krasnoyarsk
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Nalchik
country: Russian Federation
facility: Novartis Investigative Site
city: Nizhniy Novgorod
country: Russian Federation
facility: Novartis Investigative Site
city: Novosibirsk
country: Russian Federation
facility: Novartis Investigative Site
city: Perm
country: Russian Federation
facility: Novartis Investigative Site
city: Podolsk
country: Russian Federation
facility: Novartis Investigative Site
city: Pyatigorsk
country: Russian Federation
facility: Novartis Investigative Site
city: Rostov-On-Don
country: Russian Federation
facility: Novartis Investigative Site
city: Saint Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: Saransk
country: Russian Federation
facility: Novartis Investigative Site
city: Saratov
country: Russian Federation
facility: Novartis Investigative Site
city: Sevastopol
country: Russian Federation
facility: Novartis Investigative Site
city: Simferopol
country: Russian Federation
facility: Novartis Investigative Site
city: St Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: Tambov
country: Russian Federation
facility: Novartis Investigative Site
city: Tula
country: Russian Federation
facility: Novartis Investigative Site
city: Tver
country: Russian Federation
facility: Novartis Investigative Site
city: Tyumen
country: Russian Federation
facility: Novartis Investigative Site
city: Ufa
country: Russian Federation
facility: Novartis Investigative Site
city: Vladivostok
country: Russian Federation
facility: Novartis Investigative Site
city: Voronezh
country: Russian Federation
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: