A Non-interventional Study for Kisqali (Ribociclib) in Combination With an Aromatase Inhibitor for Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer at High Risk of Recurrence to Evaluate Real-world Effectiveness, Safety Profile, Patient Compliance and Quality of Life
Study on Kisqali for early breast cancer at high risk of return
Plain English Summary
A Non-interventional Study for Kisqali (Ribociclib) in Combination With an Aromatase Inhibitor for Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer at High Risk of Recurrence is a Not Applicable clinical trial sponsored by Novartis Pharmaceuticals studying Breast Neoplasms. This study observes how well Kisqali works in real-world settings for women with early breast cancer. It is for patients with HR+/HER2- early breast cancer who are at high risk of the cancer returning. Participation involves being treated with Kisqali and an aromatase inhibitor as decided by your doctor, and your treatment outcomes will be tracked. Alternatives include other endocrine therapies or abemaciclib, depending on your doctor's recommendation. The trial aims to enroll 3250 participants.
Official Summary
This non-interventional observational study evaluates the real-world effectiveness and safety profile of ribociclib in combination with an aromatase inhibitor for adjuvant treatment in patients with HR+/HER2- early breast cancer at high risk of recurrence, as well as patient compliance and quality of life.
Who Can Participate
Here is what you need to know about eligibility for this trial. You can join if you have been diagnosed with HR+/HER2- early breast cancer and your doctor has decided you should receive Kisqali with an aromatase inhibitor, or abemaciclib, or endocrine therapy alone. You must be 18 years or older and provide informed consent. You cannot join if you are currently in another experimental drug trial or a Novartis-sponsored observational study involving Kisqali. This trial is studying Breast Neoplasms, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The primary outcome measures how long patients remain free from invasive cancer after 36 months, indicating the treatment's effectiveness in preventing the cancer from returning or spreading. The specific primary outcome measures are: Invasive disease-free survival (iDFS) for adjuvant therapy with ribociclib + AI ± LHRH in participants with HR+/HER2- eBC at high risk of recurrence (36 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 real-world data on how effective and safe Kisqali is for patients with early breast cancer at high risk of recurrence, filling a gap in understanding it This research targets Breast Neoplasms, where improved treatment options are needed.
Investor Insight
This study signals strong investor confidence in Kisqali's market potential within the large and competitive breast cancer treatment landscape, suggesting a high probability of continued use and poten The large enrollment target of 3250 participants suggests significant investment in this program.
Is This Trial Right for Me?
Ask your doctor about the specific risks and benefits of Kisqali and aromatase inhibitors for your situation. Understand how your treatment decisions will be made and how your progress will be monitored throughout the study. Be prepared for regular doctor visits and potential side effects as part of your ongoing treatment. This trial is currently recruiting participants. 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: 3,250 participants
Interventions
- DRUG: ribociclib + AI ± LHRH — ribociclib in combination with an aromatase inhibitor ± LHRH as described in the current effective summary of product characteristics. This is an observational study. There is no treatment allocation. The decision to initiate treatment will be based solely on clinical judgement.
- DRUG: abemaciclib + ET ± LHRH — abemaciclib in combination with an endocrine therapy ± LHRH as described in the current effective summary of product characteristics. This is an observational study. There is no treatment allocation. The decision to initiate treatment will be based solely on clinical judgement.
- DRUG: ET mono ± LHRH — endocrine monotherapy ± LHRH. This is an observational study. There is no treatment allocation. The decision to initiate treatment will be based solely on clinical judgement.
Primary Outcomes
- Invasive disease-free survival (iDFS) for adjuvant therapy with ribociclib + AI ± LHRH in participants with HR+/HER2- eBC at high risk of recurrence (36 months)
Secondary Outcomes
- Number of participants per Baseline parameters (baseline)
- Reasons for treatment decision by treating physician (baseline)
- Patients' individual perception of risk of recurrence and treatment decision (baseline)
- Invasive disease-free survival (iDFS) (ribociclib cohort) (12 and 24 months)
- Invasive breast cancer-free survival (iBCFS) (ribociclib cohort) (12, 24 and 36 months)
Full Eligibility Criteria
Inclusion Criteria: * Histological diagnosis of HR+/HER2- early breast cancer with curative intent * Patients must have an indication for a treatment with ribociclib + AI ± LHRH as described in the current SmPC/"Fachinformation" of ribociclib (to be included into the cohorts of ribociclib + AI ± LHRH and ET mono ± LHRH) or abemaciclib + ET ± LHRH as described in the current SmPC/"Fachinformation" of abemaciclib (to be included into the abemaciclib + ET ± LHRH cohort) in the adjuvant setting * Before enrollment the treating physician has made the decision in accordance with the patient to treat the patient with either * ribociclib + AI ± LHRH, or * ET mono ± LHRH, or * abemaciclib + ET ± LHRH and baseline is no longer than 2 weeks (14 days) prior to written informed consent for this study. Baseline = for ribociclib + AI ± LHRH cohort: date of therapy start; for abemaciclib + ET ± LHRH cohort: date of therapy start; for ET mono ± LHRH cohort: within 4 weeks after therapy start or within 4 weeks after last non-endocrine based therapy, whichever is last. * ≥18 years of age * Written informed consent Exclusion Criteria: \- Patient is simultaneously participating in any investigational trial or simultaneously participating in another Novartis-sponsored non-interventional study with ribociclib.
Trial Locations
- Novartis Investigative Site, Innsbruck, Tyrol, Austria
- Novartis Investigative Site, Linz, Upper Austria, Austria
- Novartis Investigative Site, Graz, Austria
- Novartis Investigative Site, Klagenfurt, Austria
- Novartis Investigative Site, Leoben, Austria
- Novartis Investigative Site, Schwaz, Austria
- Novartis Investigative Site, Steyr, Austria
- Novartis Investigative Site, Vienna, Austria
- Novartis Investigative Site, Vienna, Austria
- Novartis Investigative Site, Vienna, Austria
- ...and 10 more locations
Frequently Asked Questions
What is clinical trial NCT06830720?
NCT06830720 is a Not Applicable OBSERVATIONAL study titled "A Non-interventional Study for Kisqali (Ribociclib) in Combination With an Aromatase Inhibitor for Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer at High Risk of Recurrence." It is currently recruiting and is sponsored by Novartis Pharmaceuticals. The trial targets enrollment of 3250 participants.
What conditions does NCT06830720 study?
This trial investigates treatments for Breast Neoplasms. The primary condition under study is Breast Neoplasms.
What treatments are being tested in NCT06830720?
The interventions being studied include: ribociclib + AI ± LHRH (DRUG), abemaciclib + ET ± LHRH (DRUG), ET mono ± LHRH (DRUG). ribociclib in combination with an aromatase inhibitor ± LHRH as described in the current effective summary of product characteristics. This is an observational study. There is no treatment allocation. The decision to initiate treatment will be based solely on clinical judgement.
What does Not Applicable mean for NCT06830720?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT06830720?
This trial is currently "Recruiting." It started on 2025-02-20. The estimated completion date is 2030-06-30.
Who is sponsoring NCT06830720?
NCT06830720 is sponsored by Novartis Pharmaceuticals. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT06830720?
The trial aims to enroll 3250 participants. The trial is currently recruiting and accepting new participants.
How is NCT06830720 designed?
This is a observational study.
What are the primary outcomes being measured in NCT06830720?
The primary outcome measures are: Invasive disease-free survival (iDFS) for adjuvant therapy with ribociclib + AI ± LHRH in participants with HR+/HER2- eBC at high risk of recurrence (36 months). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT06830720 being conducted?
This trial is being conducted at 20 sites, including Innsbruck, Tyrol; Linz, Upper Austria; Graz; Klagenfurt and 16 more sites (Austria, Germany).
Where can I find official information about NCT06830720?
The official record for NCT06830720 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06830720. This government database provides the most up-to-date and detailed information about the trial.
What is NCT06830720 testing in simple terms?
This study observes how well Kisqali works in real-world settings for women with early breast cancer. It is for patients with HR+/HER2- early breast cancer who are at high risk of the cancer returning.
Why is this trial significant?
This study is important because it will provide real-world data on how effective and safe Kisqali is for patients with early breast cancer at high risk of recurrence, filling a gap in understanding it
What are the potential risks of participating in NCT06830720?
Common side effects may include fatigue, nausea, diarrhea, and low blood cell counts. There is a risk of more serious side effects, such as liver problems or heart rhythm changes, which will be closely monitored. The effectiveness of the treatment may vary between individuals. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT06830720?
Ask your doctor about the specific risks and benefits of Kisqali and aromatase inhibitors for your situation. Understand how your treatment decisions will be made and how your progress will be monitored throughout the study. Be prepared for regular doctor visits and potential side effects as part of your ongoing treatment. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT06830720 signal from an investment perspective?
This study signals strong investor confidence in Kisqali's market potential within the large and competitive breast cancer treatment landscape, suggesting a high probability of continued use and poten This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participation involves being treated with Kisqali and an aromatase inhibitor as decided by your doctor, and your treatment outcomes will be tracked. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.