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Study identifier: NCT05550415 Synced from ClinicalTrials.gov · July 28, 2026
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The Role of Simvastatin in the Epithelial-Mesenchymal Transition Process of Breast Cancer

Condition: Triple Negative Breast Cancer · Chemotherapy Effect · Simvastatin Adverse Reaction  ·  Sponsor: Indonesia University

PhasePhase 2
Planned participants26
Who can joinFemale, 18 Years to no upper limit
Healthy volunteersNo

About this study

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 to evaluate the role of a combination between NAC and simvastatin on therapeutic response in TNBC patients through vimentin expression. Methods: This study is a double-blind, randomized, placebo-controlled trial conducted in Dr. Cipto Mangunkusumo National Central General Hospital. An expected total of 26 TNBC patients will be assessed for eligibility and asked for informed consent. Patients with the plan to have ACT (Doxorubicin hydrochloride, Cyclophosphamide, Paclitaxel) chemotherapy regimen will receive either a combination of ACT-Simvastatin (40 mg/day) or ACT-Placebo. The biopsy will be …

This description comes directly from the study's public registry record.

Talk to the study team

Erwin D Yulian, MD  ·  +6281315249627  ·  erwin.yulian@ui.ac.id

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Locations (1)

Dr. Cipto Mangunkusumo National Central General HospitalJakarta Pusat, DKI Jakarta, IndonesiaRecruiting

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Source record: clinicaltrials.gov/study/NCT05550415