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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

NCT06625333

Active Not RecruitingN/A

Sponsor: Novartis Pharmaceuticals

Conditions: HR+HER2- Advanced Breast Cancer

Countries: Russia

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.

Eligibility overview

Sex: ALL

Age: 65 Years to 99 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

1. Age ≥ 65 years at the moment of ribociclib+ET initiation
2. Female/Male gender
3. 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
4. Patient who initiated treatment with ribociclib+IA/FUL no longer than 4 weeks (28 days) prior to written informed consent for this study
5. Provision of written informed consent.

Exclusion Criteria:

1. Patients with a life expectancy of less than 3 months 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 research or NIS can be included as long as their standard of care is not altered by the study)
3. Patients on active treatment for malignancies other than aBC within 3 years before BC diagnosis
4. Patients with active cardiac disease, or history of cardiac dysfunction, including prolonged QT interval corrected using Fridericia's formula (QTcF \> 450 msec).

Locations (20)

Arkhangelsk, Russia
Barnaul, Russia
Bryansk, Russia
Chelyabinsk, Russia
Irkutsk, Russia
Kemerovo, Russia
Khabarovsk, Russia
Khanty-Mansiysk, Russia
Kirov, Russia
Krasnoyarsk, Russia
Obninsk, Russia
Perm, Russia
Rostov-on-Don, Russia
Saint Petersburg, Russia
Saint Petersburg, Russia
Tambov, Russia
Tver', Russia
Ufa, Russia
Yaroslavl, Russia
Yekaterinburg, Russia