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

NCT07647042 | Completed

• 1 other identifier: CLEE011O1US05
• Study Type: observational
• Target: 750
• Locations: 1 country
• Sites: 1

Brief 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 (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-

Outcome Measures

Primary Outcomes (7)

• 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).

  Baseline, up to approximately 1 year, 7 months

• 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.

  Baseline, up to approximately 1 year, 7 months

• 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.

  Baseline, up to approximately 1 year, 7 months

• Time From Surgery to Start of Adjuvant ET

  Up to 1 year

• Time From Surgery to Start of CDK4/6i Treatment

  Up to 1 year

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

  Up to approximately 1 year, 7 months

• 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.

  Up to approximately 1 year, 4 months

Secondary Outcomes (30)

• Baseline Demographics

  Baseline

• Height

  Baseline

• Weight

  Baseline

• Body Mass Index (BMI)

  Baseline

• Number and Percentage of Patients by Patient Characteristics

  Baseline

Study Arms (1)

HR+/HER2- eBC Cohort

Adult HR+/HER2- eBC patients eligible for treatment with CDK4/6i (ribociclib and abemaciclib) since the approval of ribociclib in the real-world setting.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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:
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis

East Hanover, New Jersey, 07936, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 15, 2026
• Study Start: March 31, 2026
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: June 15, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)