Using Simvastatin to Improve Treatment for Triple Negative Breast Cancer
Vimentin Expression-based Therapeutic Response in Triple Negative Breast Cancer Receiving Combination of Simvastatin and NAC: a Randomized, Double-Blind, Placebo-Controlled Trial
PHASE2 · Indonesia University · NCT05550415
This study is testing if adding simvastatin to chemotherapy can help women with advanced triple-negative breast cancer respond better to treatment.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 26 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Indonesia University (other) |
| Drugs / interventions | chemotherapy, Cyclophosphamide, Doxorubicin |
| Locations | 1 site (Jakarta Pusat, DKI Jakarta) |
| Trial ID | NCT05550415 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are female patients over 18 years old with advanced triple-negative breast cancer who are scheduled to receive neoadjuvant chemotherapy.
Not a fit: Patients who are pregnant, breastfeeding, or have previously received chemotherapy or statin therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved treatment responses and outcomes for patients with triple-negative breast cancer.
How similar studies have performed: While the use of statins in cancer treatment is being explored, this specific combination approach with simvastatin and neoadjuvant chemotherapy in TNBC is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Jakarta Pusat, DKI Jakarta
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Triple Negative Breast Cancer, Chemotherapy Effect, Simvastatin Adverse Reaction, Vimentin, Simvastatin, Epithelial-Mesenchymal Transition, Neoadjuvant Chemotherapy, Clinical Response