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Heart shield: statin may guard against chemo damage in breast cancer

NCT ID NCT07254221

Prevention Sponsor: Shiraz University of Medical Sciences 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether taking rosuvastatin, a cholesterol-lowering drug, can prevent heart damage caused by anthracycline chemotherapy in women with breast cancer. Four hundred participants will receive either rosuvastatin or a placebo daily for 12 months. The main goal is to see if the drug helps maintain heart pumping function and reduces signs of heart stress.

What this could mean

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

Active substance
rosuvastatin
What this could lead to
If it works, this could offer a simple way to protect the heart during breast cancer chemotherapy, reducing long-term heart risks.
What could go wrong
This is a Phase 4 trial, but it hasn't started yet. The benefit may be small or not apply to all patients, and statins can cause muscle pain or liver issues.

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.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 400 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 years and older

Sex

Female participants only

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: * Female individuals with ≥18 years of age * Documented breast cancer diagnosis based on imaging and pathology findings * Scheduled to receive the first time anthracycline-based chemotherapy Exclusion Criteria: * Baseline LVEF \< 50% * Prior Statin use or Statin use is indicated based on guidelines * history of congestive heart failure (CHF) or cardiomyopathy * Pregnancy or breastfeeding * Unable to provide informed consent * Unexplained persistent elevation of transaminases (\>3 times upper limits of normal) * Concomitant use of oral cyclosporine * Metastatic invasion of cancer to other organs * Previous cycles of chemotherapy * Any contraindication for statin use

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm Cardiotoxicity cardiomyopathy due to anthracyclines prevention target

As listed by the trial registrant

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

Anthracycline induced cardiotoxicity Anthracycline related cardiotoxicity in breast cancer Anthracycline-induced cardiac toxicity Breast cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    7 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Kowsar Hospital, Fars Heart Foundation

    Shiraz, Fars, Iran

  • Modarres Hospital, Shahid Beheshti University of Medical Sciences

    Tehran, Tehran Province, Iran

  • Motahari Breast Cancer Clinic

    Shiraz, Fars, 71344-1864, Iran

  • Rajaee Hospital, Iran University of Medical Sciences

    Tehran, Tehran Province, Iran

  • Sina Hospital, Tehran University of Medical Sciences

    Tehran, Tehran Province, Iran

  • Taleghani Hospital, Shahid Beheshti University of Medical Sciences

    Tehran, Tehran Province, Iran

  • Toba Oncology Department, Mazandaran University of Medical Sciences

    Sari, Mazandaran, Iran

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