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Real-World data shows promise for breast cancer combo therapy

NCT ID NCT06075758

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 30, 2026 · Updated 2 times

Summary

This study looked at the safety and effectiveness of a drug called ribociclib combined with hormone therapy for people with a certain type of advanced breast cancer (HR+/HER2-). Researchers collected real-world data from 175 patients in the Middle East to track side effects and how long the cancer stayed under control. The goal was to see how well this treatment works outside of a clinical trial setting.

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

175 people

The number who actually took part.

Started

Mar 2024

Finished

Jun 2025

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- advanced/metastatic breast cancer patients who have received Ribociclib in combination with hormonal therapy in pre-and postmenopausal women or men in Middle Eastern countries

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: 1. Adult patients ≥ 18 years old at the time of receiving Ribociclib in combination with hormonal therapy. 2. Advanced /metastatic breast cancer 3. Estrogen-receptor-positive and/or progesterone receptor-positive breast cancer. 4. HER2-negative breast cancer. 5. Patients who received or currently receiving Ribociclib in combination with hormonal therapy in the first or second-line settings as per the routine practice. 6. For the ambispective part, patients should have initiated the Ribociclib, in combination with hormonal therapy, line of treatment at least 12 months before the patient's recruitment date and still continuingcontinuing the drug at the baseline visit. 7. For retrospective patients only, the patients should have been on Ribocilib, in combination with hormonal therapy, for at least 18 months and stopped Ribociclib before the SIV date.enrollment 8. For ambispective part, patients agree to sign informed consent before their enrollment. Exclusion Criteria: 1. Ribociclib-based treatment regimen beyond the second line. 2. Patients are currently participating in any other clinical trials. 3. Patient with a known hypersensitivity to any of the excipients of Ribociclib. 4. Patients who previously received any other CDK4/6 inhibitor . 5. For ambispective patients, patients who refuse to sign the informed consent

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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 Investigative Site

    Amman, 11941, Jordan

  • Novartis Investigative Site

    Muscat, 111, Oman

  • Novartis Investigative Site

    Al Ain Abu Dhabi, United Arab Emirates

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