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Real-World data could unlock better breast cancer treatment choices

NCT ID NCT07647042

Knowledge-focused Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at medical records from 750 people with a common type of early breast cancer (HR+/HER2-). It aims to understand how doctors treat these patients in real life, especially after newer targeted drugs called CDK4/6 inhibitors became available. By analyzing treatment patterns, genetic testing use, and patient outcomes, the study hopes to improve care for future patients.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could reveal how well new targeted therapies work in everyday practice, helping doctors choose the best treatments for early breast cancer.
What could go wrong
This is an observational study using existing medical records, so it cannot prove cause and effect. Results may be limited by incomplete data or differences in patient care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

750 people

The number who actually took part.

Started

Mar 2026

Finished

Apr 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria: * 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: 1. Nodal stage (N) N2 or N3 disease. 2. 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. 3. Node-negative with the following high-risk criteria: 1. Tumor size is T3, T4 2. Tumor size is T2 and Grade 3 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 Exclusion criteria: * 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.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm hormone receptor-positive breast cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer

Contacts and locations

Locations

  • Novartis

    East Hanover, New Jersey, 07936, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.