Clinical trial · Interventional
Simvastatin Effect in Combination With Neoadjuvant Chemotherapy to Clinical Response and Tumor-Free Margin in Locally Advanced Breast Cancer
Combination of CAF and Simvastatin Improves Response to Neoadjuvant Chemotherapy and Increases Tumor-Free Margin in Locally Advanced Breast Cancer: A Randomized, Double-Blind, Placebo-Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Introduction: Neoadjuvant chemotherapy (NACT) has been the standard therapy for treating patients with locally advanced breast cancer (LABC). Doxorubicin-based regimen showed a clinical response for 70-80%. However, the cardiotoxicity from it was not tolerable. Simvastatin acts synergistically with doxorubicin against MCF-7 cells, through downregulation of the cell cycle or induction of apoptosis. Also, it alleviates doxorubicin cardiotoxicity by attenuating ER stress and activating the Akt pathway. Hmgcris a new pathway mediating doxorubicin-induced cell death, and cholesterol control drugs combined with doxorubicin could enhance efficacy and reduce side effects. This study is conducted to see the combination simvastatin and CAF would increase the NACT response and surgical margin of LABC patients. Methods: This study was a double-blind, randomized placebo-controlled trial, conducted in dr. Cipto Mangunkusumo General Hospital and Koja General Hospital. A total of 70 LABC patients were assessed for eligibility. Patients received either a combination of CAF-Simvastatin (40 mg/day) or CAF-Placebo. The biopsy was taken pre-NACT to make the histopathological diagnosis and examine the expression of HMG-CoA Reductase (Hmgcr) and P-glycoprotein (P-gp). Patients were evaluated for the clinical response after 3 cycles. If the response was positive, patients will proceed to surgery. Then, the post-operative specimen will be reviewed for the pathological response. However, if it was a negative response, patients will be given 2nd line NACT.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Chemotherapy Effect | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo oral capsule | Drug | — | UNRESOLVED |
| Simvastatin 40mg | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Simvastatin
- description
- The group received standard treatment with the oral administration of Simvastatin
- interventionNames
- Drug: Simvastatin 40mg
- type
- EXPERIMENTAL
- label
- Placebo
- description
- The group received standard treatment with the oral administration of Placebo
- interventionNames
- Drug: Placebo oral capsule
Primary outcomes (1)
- measure
- Clinical Response as WHO 1979
- timeFrame
- 3 months
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * LABC IIIA-IIIC TNM / AJCC 2018 with histopathological examination. * Patients are planned to get NACT * Performance status of Eastern Cooperative Oncology Group (ECOG) 0-2. * LABC patients who have not received surgery, radiation or systemic therapy and previous statin therapy. * Normal kidney organ function (serum creatinine ≤ 1.5 upper limit normal). * Normal liver organ function (ALT ≤ 2 times the normal limit, or total bilirubin level ≤ 1.5 times the normal upper limit) * Heart function (E / F)\> 55% * Willing to participate in this study by signing an informed consent Exclusion Criteria: * LABC patients are both residual and recurrent. * Allergy to tattoo ink * Allergy to statins * Patients are pregnant or breastfeeding
References
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