NCT05550415 The Role of Simvastatin in the Epithelial-Mesenchymal Transition Process of Breast Cancer
| NCT ID | NCT05550415 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Indonesia University |
| Condition | Triple Negative Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 26 participants |
| Start Date | 2022-08-19 |
| Primary Completion | 2025-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 26 participants in total. It began in 2022-08-19 with a primary completion date of 2025-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 taken pre-NAC to make the histopathological diagnosis and examine the expression of vimentin. Patients will be evaluated for adverse effects reaction every cycle and the clinical response after 8 cycles. The post-intervention biopsy will be conducted after the cycle finish. The pathological response and vimentin expression will be reviewed from the obtained samples.
Eligibility Criteria
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.
Contact & Investigator
Erwin D Yulian, MD
PRINCIPAL INVESTIGATOR
Surgical Oncology Division, Department of Surgery, Universitas Indonesia
Frequently Asked Questions
Who can join the NCT05550415 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Triple Negative Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05550415 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05550415 currently recruiting?
Yes, NCT05550415 is actively recruiting participants. Contact the research team at erwin.yulian@ui.ac.id for enrollment information.
Where is the NCT05550415 trial being conducted?
This trial is being conducted at Jakarta Pusat, Indonesia.
Who is sponsoring the NCT05550415 clinical trial?
NCT05550415 is sponsored by Indonesia University. The principal investigator is Erwin D Yulian, MD at Surgical Oncology Division, Department of Surgery, Universitas Indonesia. The trial plans to enroll 26 participants.
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