Real World Treatment Patterns and Outcomes in HR+, HER2- Metastatic Breast Cancer Patients Treated With CDK 4/6 Inhibition in the First Line (1L) Setting
Real-world study of breast cancer treatments with CDK4/6 inhibitors
Plain English Summary
A Study of Real-World Treatment Patterns and Outcomes Among HR+/HER2- Metastatic Breast Cancer Patients Treated With First-Line CDK4/6 Inhibitors is a Not Applicable clinical trial sponsored by Novartis Pharmaceuticals studying Breast Cancer. This study looks at how patients with a specific type of breast cancer (HR+, HER2- metastatic) are treated with CDK4/6 inhibitors in everyday medical practice. It is for patients diagnosed with HR+, HER2- metastatic breast cancer who have started treatment with a CDK4/6 inhibitor. Participation involves reviewing existing medical records; no new treatments or procedures are required. Alternatives include standard treatment protocols for this type of breast cancer, which may vary based on individual patient factors and physician recommendations. The trial aims to enroll 480 participants.
Official Summary
The aim of this study was to evaluate patient profiles, treatment patterns, and outcomes of hormone receptor positive (HR+)/human epidermal growth factor receptor-2 negative (HER2-) metastatic breast cancer (mBC) patients treated with a 1L cyclin dependent kinase 4/6 inhibitor (CDK4/6i) in the real-world setting.
Who Can Participate
Here is what you need to know about eligibility for this trial. Patients must have been diagnosed with metastatic breast cancer (cancer that has spread). The cancer must be HR+ (hormone receptor-positive) and HER2- (human epidermal growth factor receptor 2-negative). Patients must have received a first-line treatment with a CDK4/6 inhibitor (ribociclib, palbociclib, or abemaciclib). Patients cannot have received any CDK4/6 inhibitors before this first-line treatment, nor other specific prior treatments for metastatic breast cancer. This trial is studying Breast Cancer, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcomes measure details about the patients receiving ribociclib, such as their age at diagnosis and when they started treatment, to understand the characteristics of those treated with th The specific primary outcome measures are: Number and Percentage of Patients Treated With 1L Ribociclib by Demographic Category (Baseline); Age at 1L Ribociclib Treatment Initiation (Baseline); Among 1L Ribociclib Patients, Age at mBC Diagnosis (Baseline); Among 1L Ribociclib Patients, Age at Initial BC Diagnosis (Baseline); Interval Between mBC Diagnosis and 1L Ribociclib Initiation (Baseline). 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 trial matters because it provides insights into how CDK4/6 inhibitors are used in real-world settings for metastatic breast cancer, helping to understand treatment patterns and outcomes beyond co This research targets Breast Cancer, where improved treatment options are needed.
Investor Insight
This observational study by Novartis, a major pharmaceutical company, focuses on a key treatment area for metastatic breast cancer, suggesting continued interest in understanding the real-world effect
Is This Trial Right for Me?
Ask your doctor if your treatment aligns with current real-world practices for your type of breast cancer. Understand that this study uses your existing medical information, so no extra visits or tests are needed for the study itself. Your privacy is protected as the study uses de-identified data from your medical records. The trial is being conducted at 1 site. 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: 480 participants
Primary Outcomes
- Number and Percentage of Patients Treated With 1L Ribociclib by Demographic Category (Baseline)
- Age at 1L Ribociclib Treatment Initiation (Baseline)
- Among 1L Ribociclib Patients, Age at mBC Diagnosis (Baseline)
- Among 1L Ribociclib Patients, Age at Initial BC Diagnosis (Baseline)
- Interval Between mBC Diagnosis and 1L Ribociclib Initiation (Baseline)
Secondary Outcomes
- Number and Percentage of 1L Ribociclib Patients by Type of First Dose Adjustment (Up to approximately 7 years and 6 months)
- Among 1L Ribociclib Patients, Number of Total Dose Adjustments (Up to approximately 7 years and 6 months)
- Number and Percentage of 1L Ribociclib Patients by Starting Dose of Ribociclib (Baseline)
- Relative Dose Intensity (RDI) of Ribociclib (Up to approximately 7 years and 6 months)
- Ribociclib Dose at First Dose Adjustment (Up to approximately 7 years and 6 months)
Full Eligibility Criteria
Inclusion criteria: * A diagnosis of mBC based on at least two diagnoses of breast cancer (International Classification of Diseases, 10th Revision, Clinical Modification \[ICD-10-CM\] code C50.xxx) along with a diagnosis of secondary malignant neoplasm (ICD-10-CM codes C77.xxx - C80.xxx except C79.8 or C79.81, reporting of a metastatic site by curation), in the period prior to or on the index date. * Patients with HR+/HER2- status. * Use of either ribociclib, palbociclib, or abemaciclib in 1L treatment for mBC. * Continuous care at the contributing practices. Patients with a minimum of two visits up to and including the index date. Exclusion criteria: * Use of any prior CDK4/6i before the index date. * Prior 1L treatment, other than CDK4/6i, in mBC including treatment with endocrine therapy (ET) either with tamoxifen, aromatase inhibitors (AI; anastrozole, exemestane, or letrozole) or fulvestrant. For it to be considered 1L in mBC, the diagnosis of mBC must have preceded treatment initiation, or was indicated so in unstructured data. * Diagnosis of cancer other than breast cancer and/or mBC on or prior to the index. * Evidence of participation in a clinical trial at any time during the study observation period.
Trial Locations
- Novartis, East Hanover, New Jersey, United States
Frequently Asked Questions
What is clinical trial NCT07512063?
NCT07512063 is a Not Applicable OBSERVATIONAL study titled "A Study of Real-World Treatment Patterns and Outcomes Among HR+/HER2- Metastatic Breast Cancer Patients Treated With First-Line CDK4/6 Inhibitors." It is currently completed and is sponsored by Novartis Pharmaceuticals. The trial targets enrollment of 480 participants.
What conditions does NCT07512063 study?
This trial investigates treatments for Breast Cancer. The primary condition under study is Breast Cancer.
What does Not Applicable mean for NCT07512063?
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 NCT07512063?
This trial is currently "Completed." It started on 2024-10-08. The estimated completion date is 2025-03-17.
Who is sponsoring NCT07512063?
NCT07512063 is sponsored by Novartis Pharmaceuticals. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07512063?
The trial aims to enroll 480 participants. The trial status is completed.
How is NCT07512063 designed?
This is a observational study.
What are the primary outcomes being measured in NCT07512063?
The primary outcome measures are: Number and Percentage of Patients Treated With 1L Ribociclib by Demographic Category (Baseline); Age at 1L Ribociclib Treatment Initiation (Baseline); Among 1L Ribociclib Patients, Age at mBC Diagnosis (Baseline); Among 1L Ribociclib Patients, Age at Initial BC Diagnosis (Baseline); Interval Between mBC Diagnosis and 1L Ribociclib Initiation (Baseline). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07512063 being conducted?
This trial is being conducted at 1 site, including East Hanover, New Jersey (United States).
Where can I find official information about NCT07512063?
The official record for NCT07512063 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07512063. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07512063 testing in simple terms?
This study looks at how patients with a specific type of breast cancer (HR+, HER2- metastatic) are treated with CDK4/6 inhibitors in everyday medical practice. It is for patients diagnosed with HR+, HER2- metastatic breast cancer who have started treatment with a CDK4/6 inhibitor.
Why is this trial significant?
This trial matters because it provides insights into how CDK4/6 inhibitors are used in real-world settings for metastatic breast cancer, helping to understand treatment patterns and outcomes beyond co
What are the potential risks of participating in NCT07512063?
The main risk is that the study uses existing data, so it doesn't directly address new risks or side effects from treatment. Side effects are related to the CDK4/6 inhibitor treatments themselves, which can include low blood cell counts, fatigue, nausea, and diarrhea, as managed by your doctor. The study's observational nature means it doesn't involve experimental interventions, thus avoiding risks associated with new drug testing. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07512063?
Ask your doctor if your treatment aligns with current real-world practices for your type of breast cancer. Understand that this study uses your existing medical information, so no extra visits or tests are needed for the study itself. Your privacy is protected as the study uses de-identified data from your medical records. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07512063 signal from an investment perspective?
This observational study by Novartis, a major pharmaceutical company, focuses on a key treatment area for metastatic breast cancer, suggesting continued interest in understanding the real-world effect 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 reviewing existing medical records; no new treatments or procedures are required. 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.
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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.