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

Plain English Summary

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 is a Not Applicable clinical trial sponsored by Novartis Pharmaceuticals studying Breast Cancer. This study observes how different treatments (ribociclib, alpelisib, endocrine therapy, or chemotherapy) are used in real-world practice for advanced breast cancer in Russia. It is for women with HR+/HER2- advanced or metastatic breast cancer who are starting one of these treatments. Participation involves being monitored as your doctor prescribes your treatment; no new treatments or procedures are assigned by the study. Alternatives to participating include receiving standard medical care for your condition without being part of this observation. The trial aims to enroll 2424 participants.

Official 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.

Who Can Participate

Here is what you need to know about eligibility for this trial. Women aged 18 or older with a confirmed diagnosis of advanced or metastatic HR+/HER2- breast cancer. Patients who have started treatment with ribociclib, alpelisib, endocrine therapy, or chemotherapy within the last 4 weeks. Individuals with a general health status (ECOG performance status) of 2 or less. Patients with a life expectancy of at least 3 months and not currently in another interventional clinical trial or receiving active treatment for other cancers. This trial is studying Breast Cancer, so participants generally need a confirmed diagnosis.

What They're Measuring

The primary outcome, 'Time to Treatment Failure,' measures how long patients remain on their initial treatment before it stops working or they switch to another therapy, indicating the effectiveness o The specific primary outcome measures are: Time to treatment failure (TTF) (Up to 24 months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This study is important because it will provide insights into how advanced breast cancer is treated in routine care in Russia, helping to understand treatment patterns and outcomes for patients receiv This research targets Breast Cancer, where improved treatment options are needed.

Investor Insight

This observational study, sponsored by Novartis, focuses on specific breast cancer treatments, suggesting a market interest in understanding real-world usage and outcomes for these therapies in Russia The large enrollment target of 2424 participants suggests significant investment in this program.

Is This Trial Right for Me?

Ask your doctor about the specific treatment you are starting and why it was chosen for you. Understand that this study observes your current treatment plan and does not involve experimental procedures or changes to your care. Your regular doctor's appointments and medical care will continue as usual. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: OBSERVATIONAL
• Enrollment: 2,424 participants

Interventions

• OTHER: ribociclib — There is no treatment allocation. Patients administered ribociclib by prescription that have started before inclusion of the patient into the study will be enrolled.
• OTHER: aplelicib — There is no treatment allocation. Patients administered aplelicib by prescription that have started before inclusion of the patient into the study will be enrolled.
• OTHER: mono endocrine therapy — There is no treatment allocation. Patients administered mono endocrine therapy by prescription that have started before inclusion of the patient into the study will be enrolled.
• OTHER: chemotherapy — There is no treatment allocation. Patients administered chemotherapy by prescription that have started before inclusion of the patient into the study will be enrolled.

Primary Outcomes

• Time to treatment failure (TTF) (Up to 24 months)

Secondary Outcomes

• Line of treatment (Baseline)
• ECOG status (Up to 24 months)
• Location of metastases (Baseline)
• Menopausal status (Baseline)
• Number of patients with comorbidities (Baseline)

Full 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.

Trial Locations

• Novartis Investigative Site, Syktyvkar, Komi, Russia
• Novartis Investigative Site, Sochi, Russian Federation, Russia
• Novartis Investigative Site, Kaluga, Russia, Russia
• Novartis Investigative Site, Surgut, Tymen Area, Russia
• Novartis Investigative Site, Arkhangelsk, Russia
• Novartis Investigative Site, Barnaul, Russia
• Novartis Investigative Site, Belgorod, Russia
• Novartis Investigative Site, Bryansk, Russia
• Novartis Investigative Site, Cheboksary, Russia
• Novartis Investigative Site, Chelyabinsk, Russia
• ...and 10 more locations

Frequently Asked Questions

Related Conditions

• Breast Cancer
• Hormone Receptor-Positive Breast Cancer
• HER2-Negative Breast Cancer
• Advanced Breast Cancer
• Metastatic Breast Cancer
• Endocrine Therapy Resistance
• Hormonal Therapy
• Chemotherapy
• Oncology
• Cancer Treatment

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