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Trial Title:
The Role of Simvastatin in the Epithelial-Mesenchymal Transition Process of Breast Cancer
NCT ID:
NCT05550415
Condition:
Triple Negative Breast Cancer
Chemotherapy Effect
Simvastatin Adverse Reaction
Conditions: Official terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Simvastatin
Conditions: Keywords:
Vimentin
Simvastatin
Epithelial-Mesenchymal Transition
Neoadjuvant Chemotherapy
Clinical Response
Pathological Response
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
Simvastatin 40mg
Description:
The administration of Simvastatin 40 mg in addition to ACT regiment of neoadjuvant
chemotherapy
Arm group label:
Simvastatin
Other name:
Simvastatin
Intervention type:
Drug
Intervention name:
Placebo
Description:
The administration of Placebo capsule 40 mg in addition to ACT regiment of neoadjuvant
chemotherapy
Arm group label:
Placebo
Other name:
Placebo oral capsule 40 mg
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.
Criteria for 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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Dr. Cipto Mangunkusumo National Central General Hospital
Address:
City:
Jakarta Pusat
Zip:
10430
Country:
Indonesia
Status:
Recruiting
Contact:
Last name:
Erwin D Yulian, MD
Phone:
+6281315249627
Start date:
August 19, 2022
Completion date:
August 2025
Lead sponsor:
Agency:
Indonesia University
Agency class:
Other
Source:
Indonesia University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05550415
