CompletedNot Applicable

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

United States750 participantsStarted 2026-03-31

Plain-language 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).

Who can participate

Age range

18 Years – 100 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of Eligible Population that Received Genetic Testing

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

Number and Percentage of Patients by Treatment Regimen

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

Number and Percentage of Patients With Treatment Switches

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

Time From Surgery to Start of Adjuvant ET

Timeframe: Up to 1 year

Time From Surgery to Start of CDK4/6i Treatment

Timeframe: Up to 1 year

Time From ET to Start of CDK4/6i Treatment

Timeframe: Up to approximately 1 year, 7 months

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

Timeframe: Up to approximately 1 year, 4 months

Trial details

NCT IDNCT07647042

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-04-30

View on ClinicalTrials.gov More Breast Cancer trials

Plain-language summary

Who can participate

Age range

18 Years – 100 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

What they're measuring

Percentage of Eligible Population that Received Genetic Testing

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

Number and Percentage of Patients by Treatment Regimen

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

Number and Percentage of Patients With Treatment Switches

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

Time From Surgery to Start of Adjuvant ET

Timeframe: Up to 1 year

Time From Surgery to Start of CDK4/6i Treatment

Timeframe: Up to 1 year

Time From ET to Start of CDK4/6i Treatment

Timeframe: Up to approximately 1 year, 7 months

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

Timeframe: Up to approximately 1 year, 4 months