AzTrials
AzTrials

Breast CancerLEEWARDNCT07647042

A Real-World Study of Early Breast Cancer Patients Eligible for Treatment With CDK4/6 Inhibitors

An observational study of Breast Cancer, run by Novartis Pharmaceuticals at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The aim of this study was to describe treatment patterns, patient characteristics and clinical outcomes among hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) early breast cancer (eBC) patients who became eligible for treatment with cyclin-dependent kinase 4 and 6 inhibitors… Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Breast Cancer
How many people
750 participants
Where
1 siteUnited States
Study dates
31 Mar 2026to 30 Apr 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: HR+/HER2- eBC patients who initiated adjuvant endocrine therapy (ET) on or after 17 September 2024 up to three months prior to data cut off.

Who may be able to join

  • Diagnosed with HR+/HER2- breast cancer.
  • No evidence of distant metastatic spread.
  • Underwent primary breast cancer surgery (mastectomy/lumpectomy) during the study period.
  • Initiated adjuvant ET within 12 months of surgery date and after September 17, 2024, to the period up to 3 months prior to the data cutoff date.
  • Had at least one visit during the baseline period and at least one visit one day after the index date.
  • Patients included must have met one of the following conditions at the time of diagnosis or surgery:
Show all 12Show fewer
  • Nodal stage (N) N2 or N3 disease.
  • N1 any anatomic tumor size (T), including micrometastatic patients except T0 N1mi and T1 N1mi; For T0 N1mi and T1 N1mi patients with Grade 3 disease alone will be selected.
  • Node-negative with the following high-risk criteria:
  • Tumor size is T3, T4
  • Tumor size is T2 and Grade 3
  • Tumor size is T2 with Grade 2 and either Ki-67 score ≥ 20% or genomic high risk based on Oncotype Dx/Mammaprint/Endopredict/Prosigna

Who cannot join

  • Use of any prior CDK4/6i before the index date.
  • Missing T or N values for both clinical and surgical stage.
  • Diagnosis of cancer other than breast cancer.
  • Evidence of participation in a clinical trial at any time during the study observation period.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Novartis

    East Hanover, New Jersey, 07936

Other trials in United States

About this study

Official title: Longitudinal Evaluation of Early Breast Cancer With Adjuvant Real-World Data in the Post-CDK4/6 Inhibitor Approval Era: Analysis Using Integra PrecisionQ Oncology Database (LEEWARD)

The aim of this study was to describe treatment patterns, patient characteristics and clinical outcomes among hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) early breast cancer (eBC) patients who became eligible for treatment with cyclin-dependent kinase 4 and 6 inhibitors (CDK4/6i) in the real-world setting after the FDA approval of ribociclib treatment for eBC.

The study used data abstracted from structured and unstructured patient electronic health records from sites available in the Integra Connect PrecisionQ database (secondary data use).

Conditions
Breast Cancer
Keywords
Early breast cancer, HR+/HER2-
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07647042
Study groupRoleWhat they receive
HR+/HER2- eBC CohortAdult HR+/HER2- eBC patients eligible for treatment with CDK4/6i (ribociclib and abemaciclib) since the approval of ribociclib in the real-world setting.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Eligible Population that Received Genetic Testing

    Testing includes germline mutation testing, Oncotype DX testing, Ki-67 scoring, and other breast cancer specific genetic tests (breast cancer index, Mammaprint, Endopredict, Prosigna).

    Measured: Baseline, up to approximately 1 year, 7 months

  2. Number and Percentage of Patients by Treatment Regimen

    Number and percentage of patients by treatment regimen in the neo-adjuvant and adjuvant setting, stratified by patient and provider characteristics, and CDK4/6i eligibility.

    Measured: Baseline, up to approximately 1 year, 7 months

  3. Number and Percentage of Patients With Treatment Switches

    Number and percentage of patients with treatment switches within the CDK4/6i and aromatase inhibitor (AI) drug classes, classified as switch due to toxicity vs. other reason.

    Measured: Baseline, up to approximately 1 year, 7 months

  4. Time From Surgery to Start of Adjuvant ET

    Measured: Up to 1 year

  5. Time From Surgery to Start of CDK4/6i Treatment

    Measured: Up to 1 year

  6. Time From ET to Start of CDK4/6i Treatment

    Measured: Up to approximately 1 year, 7 months

  7. Time From Adjuvant Chemotherapy to Start of CDK4/6i Treatment

    Time from initial adjuvant Chemotherapy to the start of CDK4/6i treatment, stratified by presence of adverse events prior to CDK4/6i initiation.

    Measured: Up to approximately 1 year, 4 months

Secondary outcomes (30)

  1. Baseline Demographics

    Measured: Baseline

  2. Height

    Measured: Baseline

  3. Weight

    Measured: Baseline

  4. Body Mass Index (BMI)

    Measured: Baseline

  5. Number and Percentage of Patients by Patient Characteristics

    Patient characteristics include:

    • Menopausal status
    • Geographic location
    • Payer type
    • Index year
    • Vital status

    Measured: Baseline

  6. Age at Initial Diagnosis of BC

    Measured: Baseline

  7. Duration Between Diagnosis of BC and Initiation of Adjuvant ET

    Measured: Baseline

  8. Number and Percentage of Patients by Clinical Characteristics

    Clinical characteristics include:

    • Eastern Cooperative Oncology Group (ECOG) performance status grade
    • Tumor, Node, Metastasis (T.N.M) classification at BC diagnosis and after surgery
    • Anatomical staging at BC diagnosis
    • Tumor grade at BC diagnosis
    • HR+ and HER2- status
    • QT prolongation
    • Molecular subtype
    • Mutation status
    • Genomic scoring tests (where available)
    • Comorbidities
    • Adverse events

    Measured: Baseline

  9. Red Blood Cell Count

    Measured: Basline

  10. Hemoglobin Level

    Measured: Baseline

  11. Hematocrit Level

    Measured: Baseline

  12. White Blood Cell Count

    Measured: Baseline

  13. Platelet Count

    Measured: Baseline

  14. Absolute Neutrophil Count (ANC)

    Measured: Baseline

  15. Serum Creatinine Level

    Measured: Baseline

  16. Liver Enzyme Levels

    • Aspartate aminotransferase (AST)
    • Alanine aminotransferase (ALT)
    • Alkaline phosphatase (ALP)

    Measured: Baseline

  17. Bilirubin Level

    Measured: Baseline

  18. Number and Percentage of Patients by Medications Used and Procedures

    Measured: Baseline, up to approximately 1 year, 7 months

  19. Time to Discontinuation or Death

    Time to all-cause discontinuation or death (TTD-all cause), TTD-all cause but recurrence, and time to adverse event-related discontinuation or death (TTD from AE).

    Measured: Up to approximately 1 year, 7 months

  20. Persistence of CDK4/6i Use

    Persistence is defined as the number of days patients were taking a CDK4/6i during a pre-defined time-interval.

    Measured: Up to approximately 1 year, 7 months

  21. Number and Percentage of Patients who Discontinued Adjuvant Treatment

    Measured: Up to approximately 1 year, 7 months

  22. Number of Patients by Reason for CDK4/6i Treatment Discontinuation

    Measured: Up to approximately 1 year, 7 months

  23. Duration of Treatment

    Measured: Up to approximately 1 year, 7 months

  24. Percentage of Patients by Dose of Treatment

    Measured: Up to approximately 1 year, 7 months

  25. Cumulative Dose

    Cumulative dose is defined as the sum of individual doses during the initial adjuvant regimen.

    Measured: Up to approximately 1 year, 7 months

  26. Dose Intensity

    Dose intensity is defined as the cumulative dose / total time period of treatment.

    Measured: Up to approximately 1 year, 7 months

  27. Relative Dose Intensity (RDI)

    RDI is defined as the observed dose intensity / expected dose intensity x 100.

    Measured: Up to approximately 1 year, 7 months

  28. Number and Percentage of Patients With Dose Reductions During Follow-up

    Measured: Up to approximately 1 year, 7 months

  29. Time to First and Subsequent Dose Reductions of CDK4/6is

    Measured: Up to approximately 1 year, 7 months

  30. Number and Percentage of Patients With Drug Interruptions

    Measured: Up to approximately 1 year, 7 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2026
  2. Study start31 Mar 2026
  3. Primary completion30 Apr 2026
  4. Study completion30 Apr 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
750 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07647042
Sponsor's protocol ID
CLEE011O1US05
Acronym
LEEWARD
Status last verified
Jun 2026
First submitted
9 Jun 2026
Last updated
15 Jun 2026
Results posted
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer, run by Novartis Pharmaceuticals at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Eligible Population that Received Genetic Testing (time frame: Baseline, up to approximately 1 year, 7 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07647042.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in