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Cholesterol drug simvastatin joins chemo in breast cancer trial

NCT ID NCT05550415

NEW Disease control Sponsor: Universitas Indonesia Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 21, 2026 · Last updated Sep 21, 2026

Summary

Researchers are testing whether adding simvastatin, a common cholesterol drug, to standard chemotherapy helps women with triple negative breast cancer. The trial enrolls 26 women with advanced triple negative breast cancer who are scheduled for eight cycles of AC-T chemotherapy. Half receive simvastatin and half receive a placebo, and researchers compare tumor samples before and after treatment to measure vimentin, a protein linked to cancer spread and drug resistance.

What this could mean

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

Active substance
simvastatin, a common cholesterol-lowering drug
What this could lead to
If simvastatin helps, it could offer a low-cost, widely available addition to chemotherapy that makes triple negative breast cancer respond better.
What could go wrong
This is a small Phase 2 trial with only 26 patients, so any benefit may not hold up in larger studies. Simvastatin can cause muscle aches and rare liver problems, and it may not affect vimentin or tumor response at all.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 26 people

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

Started

Aug 2022

Expected to finish

Dec 2026

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: 1. Female patients with advanced breast cancer (locally advanced and distantly advanced) with triple-negative molecular type confirmed by biopsy and immunohistochemical examination. 2. The patient planned to receive 8 cycles of AC-T chemotherapy. 3. Patient age \> 18 years. 4. Willing to participate in research by signing informed consent. Exclusion Criteria: 1. The patient is pregnant or breastfeeding. 2. Patients who have received chemotherapy or are on simvastatin therapy. 3. Allergy to statins.

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Conditions

The condition(s) this trial relates to.

chemotherapy-induced toxicity triple-negative breast carcinoma

As listed by the trial registrant

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

Chemotherapy effect Simvastatin adverse reaction Triple negative 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

    1 site. 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.

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  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

  • Dr. Cipto Mangunkusumo National Central General Hospital

    RECRUITING

    Jakarta Pusat, DKI Jakarta, 10430, Indonesia

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