A Phase 2 interventional study of Simvastatin 40mg and Placebo in Triple Negative Breast Cancer, Chemotherapy Effect and Simvastatin Adverse Reaction, sponsored by Universitas Indonesia. Recruiting at 1 site in Indonesia. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Universitas Indonesia · Phase 2, Interventional, and Treatment
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.
1,219 studies on the registry are indexed under Triple Negative Breast Neoplasms; 446 are open to participants now.
This study's planned enrollment of 26 is below the median of 60 across 1,053 interventional studies indexed under Triple Negative Breast Neoplasms.
Browse Triple Negative Breast Neoplasms studies →Universitas Indonesia is the lead sponsor of 35 studies on the registry; 13 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The group received standard treatment with simvastatin 40mg in capsule by oral route, once a day, for 21 days (every cycle of the chemotherapy regiment)
Drug: Simvastatin 40mg
The group received standard treatment with placebo 40mg in capsule by oral route, once a day, for 21 days (every cycle of the chemotherapy regiment)
Drug: Placebo
The administration of Simvastatin 40 mg in addition to ACT regiment of neoadjuvant chemotherapy
Also known as: Simvastatin
The administration of Placebo capsule 40 mg in addition to ACT regiment of neoadjuvant chemotherapy
Also known as: Placebo oral capsule 40 mg
Vimentin Expression
Vimentin expression is measured based on Histoscore (H-Score) with immunohistochemistry examination: * 0-50 : negative (0) * 51-100 : weak positive (1+) * 101-200 : moderate positive (2+) * 201-300 : strong positive (3+)
Time frame: 6 months
Pathological Response
Pathological Response as Measured by Miller-Payne system Evaluation before and after chemotherapy, divided into: 1. Grade 1: There is no significant change or reduction in cancer cells. 2. Grade 2: Reduction of \<30% cancer cells 3. Grade 3: Reduction of cancer cells between 30-90% 4. Grade 4: Reduction of \> 90% cancer cells 5. Grade 5 : There are no residual cancer cells. DCIS (Ductal Carcinoma In Situ) might be detected.
Time frame: 6 months
Clinical Response
Clinical response based on WHO (World Health Organization) criteria: 1. Complete Response (CR): Disappearance 2. Partial Response (PR): 50% decrease 3. Stable Disease(SD): Neither PR nor PD criteria met 4. Progressive Disease (PD):25% increase; no CR, PR, or SD documented before increased disease
Time frame: 6 months
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Studies of the drug tested here: Simvastatin
Triple Negative Breast Neoplasms →
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