Triple Negative Breast CancerPhase 2NCT05550415
The Role of Simvastatin in The Epithelial-Mesenchymal Transition Process of Breast Cancer
A Phase 2 study testing Simvastatin 40mg in people with Triple Negative Breast Cancer and Chemotherapy Effect, run by Universitas Indonesia at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Triple Negative Breast Cancer, Chemotherapy Effect, Simvastatin Adverse Reaction
- What is being tested?
- Simvastatin 40mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteIndonesia
- Study dates
- 19 Aug 2022to Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- The patient is pregnant or breastfeeding.
- Patients who have received chemotherapy or are on simvastatin therapy.
- Allergy to statins.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Indonesia1 site, 1 recruiting
- Recruiting
Dr. Cipto Mangunkusumo National Central General Hospital
Jakarta Pusat, DKI Jakarta, 10430
Erwin D Yulian, MD, +6281315249627
About this study
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
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.
- Being tested
- Simvastatin 40mg, Placebo
- Keywords
- Vimentin, Simvastatin, Epithelial-Mesenchymal Transition, Neoadjuvant Chemotherapy, Clinical Response, Pathological Response
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simvastatin 40mgDrug
Also called Simvastatin
The administration of Simvastatin 40 mg in addition to ACT regiment of neoadjuvant chemotherapy
PlaceboDrug
Also called Placebo oral capsule 40 mg
The administration of Placebo capsule 40 mg in addition to ACT regiment of neoadjuvant chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Simvastatin | Experimental | 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) Receives: Drug: Simvastatin 40mg |
| Placebo | Placebo comparator | 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) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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+)
Measured: 6 months
Secondary outcomes (2)
Pathological Response
Pathological Response as Measured by Miller-Payne system
Evaluation before and after chemotherapy, divided into:
- Grade 1: There is no significant change or reduction in cancer cells.
- Grade 2: Reduction of <30% cancer cells
- Grade 3: Reduction of cancer cells between 30-90%
- Grade 4: Reduction of > 90% cancer cells
- Grade 5 : There are no residual cancer cells. DCIS (Ductal Carcinoma In Situ) might be detected.
Measured: 6 months
Clinical Response
Clinical response based on WHO (World Health Organization) criteria:
- Complete Response (CR): Disappearance
- Partial Response (PR): 50% decrease
- Stable Disease(SD): Neither PR nor PD criteria met
- Progressive Disease (PD):25% increase; no CR, PR, or SD documented before increased disease
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start19 Aug 2022
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple Negative Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. dr. Erwin Danil Yulian, Sp.B (K) Onk, Universitas Indonesia
- Investigators
- Erwin D Yulian, MD, Principal investigator, Surgical Oncology Division, Department of Surgery, Universitas IndonesiaTantri Hellyanti, MD, Study director, Department of Pathological Anatomy, Universitas IndonesiaShabrina Adzania, MD, Study chair, Research Assistant, Department of Surgery, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05550415
- Sponsor's protocol ID
- IndonesiaU2022
- Status last verified
- Sep 2026
- First submitted
- 19 Sep 2022
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05550415
- Acronym / sponsor ID
- IndonesiaU2022
- Keywords
- Vimentin, Simvastatin, Epithelial-Mesenchymal Transition, Neoadjuvant Chemotherapy, Clinical Response, Pathological Response
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 19 Aug 2022 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 22 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simvastatin | Experimental | Drug: Simvastatin 40mgThe group received standard treatment with simvastatin 40mg in capsule by oral route, once a day, for 21 days (every cycle of the chemotherapy regiment) |
| Placebo | Placebo comparator | Drug: PlaceboThe group received standard treatment with placebo 40mg in capsule by oral route, once a day, for 21 days (every cycle of the chemotherapy regiment) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- The patient is pregnant or breastfeeding.
- Patients who have received chemotherapy or are on simvastatin therapy.
- Allergy to statins.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simvastatin 40mgAlso: SimvastatinThe administration of Simvastatin 40 mg in addition to ACT regiment of neoadjuvant chemotherapy | Drug | Simvastatin |
| PlaceboAlso: Placebo oral capsule 40 mgThe administration of Placebo capsule 40 mg in addition to ACT regiment of neoadjuvant chemotherapy | Drug | Placebo |
Primary outcome
Vimentin Expression
Time frame: 6 months
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+)
2 secondary outcomes
Pathological Response
Time frame: 6 months
Clinical Response
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Erwin D Yulian, MD principal investigator
Surgical Oncology Division, Department of Surgery, Universitas Indonesia
Tantri Hellyanti, MD study director
Department of Pathological Anatomy, Universitas Indonesia
Shabrina Adzania, MD study chair
Research Assistant, Department of Surgery, Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Simvastatin 40mg in people with Triple Negative Breast Cancer and Chemotherapy Effect, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erwin D Yulian, MD (+6281315249627, erwin.yulian@ui.ac.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vimentin Expression (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.