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The Role of Simvastatin in The Epithelial-Mesenchymal Transition Process of Breast Cancer

RecruitingPhase 2Ages 18 Years - anyFemaleUniversitas Indonesia
NCT05550415 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Introduction: Most cases of Triple Negative Breast Cancer (TNBC) have a high proliferation rate. TNBC is associated with a poor prognosis, a high recurrence rate, and a high incidence of distant metastases. The Epithelial-Mesenchymal Transition process (EMT) plays an essential role in the metastatic process. EMT markers were also more abundant in TNBC and contributed to a poorer TNBC prognosis. As an important EMT marker, the increased expression of vimentin also contributed to the increase in TNBC aggressiveness and resistance to chemotherapeutic agents. Through the mechanism of action in inhibiting the mevalonate pathway, statins can help inhibit the EMT process in metastases. Notably, simvastatin promotes the down-regulation of vimentin in breast cancer cells. The combination of statins and neoadjuvant chemotherapy (NAC) improves the cancer patient's response. This study is expected t

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📋 Eligibility rules (as published)
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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What it tests

  • Simvastatin 40mg
  • Placebo
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Where

1 site
Dr. Cipto Mangunkusumo National Central General Hospital
Jakarta Pusat, Indonesia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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