Using Simvastatin to Improve Treatment for Triple Negative Breast Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effects of simvastatin on the epithelial-mesenchymal transition (EMT) process in patients with triple-negative breast cancer (TNBC) undergoing neoadjuvant chemotherapy. It aims to evaluate whether the combination of simvastatin and chemotherapy can enhance therapeutic responses by targeting EMT markers, particularly vimentin, which is associated with cancer aggressiveness and resistance to treatment. Female patients with advanced TNBC will receive either simvastatin or a placebo alongside their chemotherapy regimen over eight cycles. The study seeks to determine if simvastatin can improve outcomes for these patients.

Why it matters

Who can join: the full rules

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.

Where it's running

• Dr. Cipto Mangunkusumo National Central General Hospital
  Jakarta Pusat, DKI Jakarta, Indonesia Recruiting

Study contacts

• Principal investigator: Erwin D Yulian, MD — Surgical Oncology Division, Department of Surgery, Universitas Indonesia
• Study coordinator: Erwin D Yulian, MD
• Email: erwin.yulian@ui.ac.id
• Phone: +6281315249627

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Granzyme B-PET to see if immunotherapy works in TNBC

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.