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Recruiting NCT05550415

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

Phase II Interventional Triple Negative Breast Cancer Chemotherapy Effect Simvastatin Adverse Reaction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Simvastatin 40mg, Placebo.
Who it may be relevant to
Registry conditions: Triple Negative Breast Cancer, Chemotherapy Effect, Simvastatin Adverse Reaction. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Indonesia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Vimentin Expression-based Therapeutic Response in Triple Negative Breast Cancer Receiving Combination of Simvastatin and NAC: a Randomized, Double-Blind, Placebo-Controlled Trial

Overview

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.

Interventions

  • Drug Simvastatin 40mg
    The administration of Simvastatin 40 mg in addition to ACT regiment of neoadjuvant chemotherapy
  • Drug Placebo
    The administration of Placebo capsule 40 mg in addition to ACT regiment of neoadjuvant chemotherapy

Primary outcome measures

  • Vimentin Expression [Time frame: 6 months]
Secondary outcome measures (2)
  • Pathological Response [Time frame: 6 months]
  • Clinical Response [Time frame: 6 months]

Eligibility criteria

Inclusion criteria

  • Female patients with advanced breast cancer (locally advanced and distantly advanced) with triple-negative molecular type confirmed by biopsy and immunohistochemical examination.
  • The patient planned to receive 8 cycles of AC-T chemotherapy.
  • Patient age > 18 years.
  • Willing to participate in research by signing informed consent.

Exclusion criteria

  • The patient is pregnant or breastfeeding.
  • Patients who have received chemotherapy or are on simvastatin therapy.
  • Allergy to statins.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Indonesia · 1 center
  • Dr. Cipto Mangunkusumo National Central General Hospital — Jakarta Pusat

Identifiers

NCT: NCT05550415 · IndonesiaU2022

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗