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Genital Diseases

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Female Urogenital Diseases

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Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

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Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

Antineoplastic Agents

All Drugs and Chemicals

Lipid Regulating Agents

Carboplatin

Doxorubicin

Liposomal doxorubicin

Simvastatin

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Anticholesteremic Agents

Hypolipidemic Agents

Antimetabolites

Enzyme Inhibitors

Simvastatin 40mg by mouth nightly for approximately 6 months during treatment with carboplatin and liposomal doxorubicin

Simvastatin 40mg

Amy Oppenheim

Cynthia Martin

Bobbie Jo Rimel, MD

Marc Goodman, PhD

Andrew Li, MD

Christine Walsh, MD

Kristin Taylor, MD

This is a single arm pilot trial to evaluate the feasibility of using a simvastatin intervention, and to evaluate its effects on cancer progression, among 20 patients with platinum-sensitive ovarian cancer, treated with carboplatin and liposomal doxorubicin at Cedars-Sinai Medical Center.

This is a pilot study of statin therapy to examine the feasibility of simvastatin use to reduce disease progression in 20 patients with platinum-sensitive ovarian cancer at Cedars-Sinai Medical Center. This study will focus on patients with recurrent platinum sensitive ovarian cancer to increase the likelihood that this population will experience recurrent disease during the 6-month intervention and follow-up. In addition, this population of patients has a narrow range of standard of care carboplatin doublet combinations that are prescribed, enabling the investigators to create a more homogenous study population. Given their high risk of developing recurrent disease, women with platinum sensitive ovarian cancer, have the potential to derive the maximum benefit from an intervention that could delay disease progression and enhance survival.

Statin Therapy to Reduce Progression in Women With Platinum Sensitive Ovarian Cancer

Percentage of patients who complete the simvastatin intervention with at least 85% compliance during Carboplatin and Doxil chemotherapy.

Duration until disease progression or death

Oncologist

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

The group received standard treatment with the oral administration of Simvastatin

The group received standard treatment with the oral administration of Placebo

The administration of Simvastatin 40 mg in addition to neoadjuvant chemoterapy CAF

The administration of Placebo capsule 40 mg in addition to neoadjuvant chemoterapy CAF

Placebo oral capsule

Nurjati Chairani Siregar, MD

Baju Adji

Filipus Dasawala, MD

Hanifah Hasan, MD

Muhammad Rizki Kamil, MD

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.

Backgrounds Neoadjuvant chemotherapy (NACT) which is followed by surgery is now a standard therapy in the local advanced breast cancer (LABC) since it was introduced 50 years ago, increasingly being used in early-stage LABC patients. Some NACT studies in RSCM use a doxorubicin-based regimen, giving a 70-80% partial response, but do not require a complete response both clinically and pathologically. The NACT response was 80% with a complete clinical response of 36%. The complete pathological response obtained after NACT is the prognosis of a replacement marker both overall and disease-free survival in the LABC. The purpose of giving NACTis to increase tumor resectability and de-escalation surgery and kill micrometastasis which will increase the length of disease-free and life expectancy of the patient. New tumor margins causing post-NACT tumor shrinkage can be used as surgical margins.

Doxorubicin-based chemotherapy is the most commonly given chemotherapy for NACT as well as entering the first line of the National Formulary. However, side effects are limited from drug resistance side effects that can cause cardiomyopathy and heart failure. One of the factors that influence doxorubicin resistance is the presence of efflux pumps such as P-glycoprotein (P-gp) on the cell surface. While the effects of toxicity arise due to the formation of reactive oxygen species (ROS) and the presence of free radicals. Efforts to improve the efficacy of the combination of chemotherapy currently being used with targeted therapies such as anti-HER-2 and bevacizumab, but have a high enough toxicity and are expensive and not included in ForNas. Likewise, some drugs that have been tested in vitro as P-gp inhibitors/modifiers, but failed in clinical trials because of ineffectiveness and greater side effects on the kidneys and heart. Some previous studies have confirmed that simvastatin is a potential ABCB1 / P-gp inhibitor.

Statins are the most widely used anti-hypercholesterolemia in the world, through inhibition of 3-hydroxy-3-methylglutaryl coenzyme-A reductase (Hmgcr) which is an enzyme that limits the use of the mevalonate pathway that can be used as intracellular cholesterol. Besides having pleiotropic effects, statins also have anti-tumor effects. At this time, statins have received approval as a potential anti-tumor agent because several epidemiological studies have agreed on the relationship between statin use and reducing the risk of recurrence of LABC after adjuvant therapy. Some preclinical studies show that statins can decrease breast cancer cell proliferation and induce apoptosis in various experimental models. results from pre-operative "window-of-opportunity" clinical trials on LABC so that statins can reduce tumor proliferation and induce apoptosis. Reports in the RSCM get simvastatin 40 mg for 4 weeks for neoadjuvant reduce the proliferation index in the LABC by 53.3% and inhibit the increase in LABC cells through the Rho / Rock pathway. Although several studios of statin antitumor activity have been carried out, the role of statins in oncology has not yielded satisfactory results or controversies and provides heterogeneous responses depending on the molecular identity and tumor type malignancy. The results of a clinical preliminary study indicate that giving a single statin is not as effective as an anti-cancer because it requires large effects and large side effects.

Several in vitro studies and animal models show that the combination of statins can increase the accumulation of intra-cell chemotherapy so that the effects of potentiation of chemotherapy arise. The administration of a combination of doxorubicin statins increases the potential for anti-cancer effects through the accumulation of doxorubicin in cancer cells, causing the potential for DNA damage, inhibition of proliferation, and induction of apoptosis. statins can also protect cardiotoxic induced by doxorubicin if it is given pre-therapy in mice. With a variety of anti-tumor mechanisms as well as the enormous benefits and potential addition of statins that can be well-tolerated, safe, and inexpensive. However, until now the effects of antiproliferation synergy and induction of apoptosis combination of simvastatin and doxorubicin in LABC patients are not well known. This study aims to determine the efficacy, tolerability, and safety of simvastatin combination and CAF chemotherapy as neo-advanced therapy in LABC patients. The use of this combination is expected to improve clinical and pathological responses as well as surgical margins while providing cardioprotection effects, so as to provide the best service with high oncological value.

Methods

1. Subject and study design This research is a double-blind, placebo-controlled clinical trial conducted at Dr. Cipto Mangunkusumo General Hospital and Koja General Hospital from January 2018 to September 2019. Eligible patients are patients with grade IIIA to IIIC invasive breast cancer that is histologically proven. A total of 60 LABC patients were included in this study. Participants received a combination of NACT CAF and Simvastatin (40 mg / day) (n = 30) or placebo (n = 30). Besides being used to make a histopathological diagnosis, samples were taken by biopsy before NACT, examined for the expression of HMG-CoA Reductase (HMGCR) and P-glycoprotein (P-gp). Participants were evaluated for the clinical response after 3 NACT cycles. If it gives a complete or partial response, then the patient will proceed to surgery. Then, the postoperative specimen will be reviewed for a pathological response. However, if it is stable or progressive, the patient will be given a 2nd line NACT.
2. Tumor assessment The primary outcome was clinical response while the secondary outcome was the pathological response, incision boundary, P-gp expression, Hmgcr expression and side effects. The analysis was performed on the population per protocol. Clinical response assessment uses WHO 1979 criteria. Pathological responses of tumors are evaluated according to the Miller-Payne scoring system. MPG classification is used to evaluate the relevance between pathological response and clinical response. The incision boundary assessment is performed using histopathological tissue incisions depending on the surgical margins of the tumor on the medial, lateral, cranial, caudal, and baseline sides of the tumor; based on the size of the new tumor. Histopathological results will determine whether the level is free from the tumor or not based on the size of the new tumor. Disease assessment is carried out by investigation after 3 NACT cycles. Side effects were assessed during treatment and for 7 days after the last treatment dose and assessed using CTCAE 3.0.
3. Biomarker assessment Estimation of P-glycoprotein (Pgp) and Hmgcr expression was seen under a microscope from a sample after a core biopsy was performed before starting chemotherapy. P-gp expression was interpreted based on the percentage of p-glycoprotein positive cells in the total cell population (low = 0%, 1+ = 1-19%, and 2 + = 20-100% positive cells). Hmgcr expression is interpreted based on the percentage of Hmgcr positive cells in the total cell population (negative = 0%, 1+ = 1-10%, 2+ = 11-50%, 3+ =\> 51-100% positive cells)..
4. Statistical analysis The main results in this study were clinical responses based on WHO 1970 criteria. ORR values in this study were calculated from the ratio of the number of patients who showed a response (complete and partial) to the total number of patients and were analyzed using the Pearson Chi-Square Test. Secondary outcomes in the form of pathological responses based on GMP and incision boundaries were analyzed using Fisher's Exact Test. Bivariate analysis of clinicopathological variables and molecular biology with the therapeutic response using the Continuity Correction Test and the Fischer's Exact Test. The results of the bivariate analysis with p\> 0.25 were performed multivariate analysis using the Logistic Regression Test. The analysis was performed with the help of a computer using the SPSS 23 program. Differences were stated to be meaningful and obtained p values \<0.05.

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

Clinical Response is measured using WHO 1979 criteria.

1. Complete Response (CR): Disappearance; confirmed at 3 months
2. Partial Response (PR): 50% decrease; confirmed at 3 months
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

Evaluation of the MP system is based on the reduction of tumor cellularity before and after chemotherapy, divided into:

1. Grade 1 ie there is no 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 is that there are no residual cancer cells. Grade 4 is categorized as partial pathology response. Grade 5 is categorized as a complete pathology response

histopathologically the tissue to the tumor incision limit on the medial, lateral, cranial, and caudal sides along with the tumor base; based on the size of the new tumor. Hisopathologically assesses the extent of incision free or not tumor based on the size of the new tumor.

Indonesia University

Lecturer, Staff of Oncology Division of Department of Surgery, Principal Investigator

Prostatic Neoplasms

Genital Neoplasms, Male

Genital Diseases, Male

Prostatic Diseases

Male Urogenital Diseases

Patients randomized to the statin group will receive 40 mg oral simvastatin QD for eight weeks prior to prostatectomy, including the day of surgery.

Patients randomized to the control group receive no intervention prior to prostatectomy.

Simvastatin 40mg taken orally daily for 8 weeks

Alan Brisendine

Jasmin M Brooks

Alan Brisendine, CCRP

Jasmin Brooks

Michael Marrone, PhD

Stephen Savage, MD

This study will evaluate whether simvastatin reduces intraprostatic immunosuppressive microenvironment through YAP-mediated T-reg dysfunction, and increases intraprostatic anti-tumor immune response in men recently diagnosed with localized prostate cancer electing to receive prostatectomy for their care. Half the men will be randomized to receive statins for 8 weeks prior to their surgery, while the other half will receive standard of care.

Prior research has demonstrated a consistently strong inverse association between statin drug use and risk of developing lethal prostate cancer, and a stronger protective effect with a longer duration of use. Further, in men with clinically localized prostate cancer, statins are associated with a reduced risk of progression to metastasis and dying from prostate cancer. For statins to have clinical utility as chemo-preventive and therapeutic (adjuvant) agents, additional characterization of the mechanisms through which statins interact with the tumor microenvironment are needed. Statin drugs have been shown to inhibit Yes-associated protein (YAP) nuclear translocation and transcriptional activation (via YAP phosphorylation) required for T regulatory cell (T-reg) immunosuppressive function. YAP is a critical regulator of the immunosuppressive microenvironment contributing to T-reg differentiation and immunosuppressive function and antitumor T cell response.

Simvastatin is a moderate intensity statin regimen recommended for cholesterol reduction, and was previously shown to have a strong cytoplasmic YAP sequestration activity. This trial is designed to investigate the effect of 40 mg oral simvastatin daily on YAP-mediate T-reg disfunction and antitumor immune response. Eligible patients include men newly diagnosed with pathologically-confirmed localized prostate cancer determined to be intermediate (stage T2b, or Gleason 7 or PSA 10-20ng/mL) or high risk (stage T2c or PSA \>/= 20 ng/mL, or Gleason \>/= 8) of biochemical recurrence at the time of biopsy; not currently taking a statin who are scheduled for prostatectomy. For the trial, 52 patients will be randomized in a 1:1 ratio to the statin group or the control group. Randomization sequence will be computer generated using random blocks with concealed allocation of the random treatment assignment (e.g., statin or control) and will be stratified by race (Black vs non-Hispanic White) and BMI (\<30 vs ≥30). Patients randomized to the statin group will receive moderate intensity simvastatin (40mg, day) for eight weeks until the date of prostatectomy. Patients randomized to the control group will not receive any intervention, this is not a placebo-controlled trial and participants, and investigators will not be masked. Patients in both groups will receive standard clinical laboratory assessments at baseline and at the end of the study after eight weeks to evaluated adherence based on the change in cholesterol and inflammation biomarkers from baseline to the end of follow-up at eight weeks. Multiplex immunofluorescence will be used to assess intra-prostatic YAP-mediate T-reg dysfunction (the number FOXP3+ T-regs with phosphorylated YAP), and intra-prostatic anti-tumor immune response (the count and density of CD4+ and CD8+ T cells) in whole tumor sections obtained from the tumor block containing the index tumor (i.e., largest and/or highest Gleason sum).

This trial is focused on prostate cancer, a cancer of a male organ, and is applicable to men only. Men from all racial and ethnic groups are eligible to participate in this trial.

T-reg Function Changes: a Novel Immune Regulatory Effect Underlying Benefit of Statin Use on Lethal Prostate Cancer

Number of men diagnosed with localized prostate cancer randomized to receive a statin prior to prostatectomy that have greater intra-prostatic YAP-mediated T-reg dysfunction compared to men randomized to the control group.

Intra-prostatic T-reg dysfunction will be determined by the proportion of Foxp3+ T-regs with phosphorylated YAP sequestered in the cytoplasm detected by multiplex immunofluorescence and digital quantitative image analysis.

Number of men randomized to the statin group that have greater YAP-mediated T-reg dysfunction compared to men randomized to the control group restricting to tumor-infiltrating T-regs only.

Intra-prostatic T-reg dysfunction will be determined by the proportion of Foxp3+ T-regs with phosphorylated YAP sequestered in the cytoplasm detected by multiplex immunofluorescence and digital quantitative image analysis.

Number of men randomized to the statin group that have greater YAP-mediated T-reg dysfunction compared to men randomized to the control group restricting to the subset of T-regs in the adjacent normal and stromal tissue area.

Intra-prostatic T-reg dysfunction will be determined by the proportion of Foxp3+ T-regs with phosphorylated YAP sequestered in the cytoplasm detected by multiplex immunofluorescence and digital quantitative image analysis.

Density (cell counts per total area evaluated) of CD4,+ CD8+, PD-1+, and CTLA-4+ T cells, and PD-L1+ tumor cells detected by multiplex immunofluorescence and digital quantitative image analysis.

Medical University of South Carolina

Associate Professor

Leiomyoma

Myofibroma

Neoplasms, Connective and Soft Tissue

Neoplasms, Connective Tissue

Connective Tissue Diseases

The 30 participants randomized in this group will intake Simvastatin 40mg / day of orally at the same time in the evening, every day for the study duration of 12 weeks prior to undergoing hysterectomy/ myomectomy. The fibroid samples will be collected after the surgery to evaluate the effects of the study medication on the fibroid tissue.

The 30 participants randomized in this group will intake Placebo 40mg / day orally at the same time in the evening every day for the study duration of 12 weeks prior to undergoing hysterectomy/ myomectomy. The fibroid samples will be collected after the surgery to evaluate the effects of the study medication on the fibroid tissue.

The Treatment Group subjects will orally intake encapsulated Simvastatin 40 mg tablets daily for the 12 weeks duration with water in the evening.

The Placebo group will orally intake encapsulated Starch 1500, 40 mg Placebo for 12 weeks duration with water in the evening.

Placebo 40 mg

Mostafa Borahay, MD, PhD

James Segars, MD

Gayane Yenokyan, PhD

Paul Driggers, PhD

Bhuchitra Singh, MBBS,MPH,MS

The study aims to study the effect of simvastatin on the size of uterine fibroids.

The study is a phase II double blinded clinical trial to determine feasibility, safety and preliminary clinical efficacy of simvastatin to reduce leiomyoma size. Women with symptomatic fibroids planned to undergo surgical management for fibroids such as hysterectomy or myomectomy will be screened for participation. The eligible women will undergo pre-study evaluation to ascertain study eligibility.The study will enroll 60 participants in total, half will receive simvastatin and the other half will receive a placebo. The study drug and placebo will be an add on to the participants ongoing medical management of fibroids until surgery. The participants will be monitored at intervals for the effect of the drug on fibroid size and symptoms using ultrasound and quality of life questionnaires.

Effects of Simvastatin on Uterine Leiomyoma Size

A Double-blinded, Phase II, Randomized Control Trial to Study the Effects of Simvastatin in Patients With Uterine Leiomyoma

Based on patient reporting and study team evaluation utilizing CTCAE v.4

Tumor size measured by ultrasound imaging comparing tumor volume using ultrasound imaging. The volume will be reported in Centimeter cubes. The largest radius of the tumor will be used to calculate the volume, this will be measured in centimeters.

The questionnaire used is the Uterine Fibroid Symptom and Health Related Quality of Life Questionnaire. This questionnaire is an effective and validated tool for detecting differences in symptom severity and health-related quality of life among patients with uterine fibroids. The scale for this questionnaire denotes symptom severity with lowest and highest possible scores of 8 and 40 respectively. Higher scores indicate greater severity of symptoms.

Based on review of patient diaries and counting of left over medications bought back by the subject. This will be reported as an overall percentage.

Based on presence at follow up visits to the study site. This will be determined as a simple percentage of subjects that stay in the study until the last visit.

National Institutes of Health (NIH)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Johns Hopkins University

Triple Negative Breast Neoplasms

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)

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)

The administration of Simvastatin 40 mg in addition to ACT regiment of neoadjuvant chemotherapy

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

Placebo

Erwin D Yulian, MD

Tantri Hellyanti, MD

Shabrina Adzania, MD

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.

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

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

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+)

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.

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Statin Therapy to Reduce Progression in Women With Platinum Sensitive Ovarian Cancer	NCT04457089	Recurrent Ovari... Platinum-sensit...	Simvastatin 40m...	18 Years -	Cedars-Sinai Medical Center
Simvastatin Effect in Combination With Neoadjuvant Chemotherapy to Clinical Response and Tumor-Free Margin in Locally Advanced Breast Cancer	NCT04418089	Breast Cancer Chemotherapy Ef...	Simvastatin 40m... Placebo oral ca...	-	Indonesia University
T-reg Function Changes: a Novel Immune Regulatory Effect Underlying Benefit of Statin Use on Lethal Prostate Cancer	NCT05586360	Prostate Cancer	Simvastatin 40m...	18 Years -	Medical University of South Carolina
Effects of Simvastatin on Uterine Leiomyoma Size	NCT03400826	Fibroid Uterus Fibroid Tumor Leiomyoma Fibromyoma Leiomyoma, Uter...	Simvastatin 40m... Placebo 40 mg	18 Years - 55 Years	Johns Hopkins University
Simvastatin Effect in Combination With Neoadjuvant Chemotherapy to Clinical Response and Tumor-Free Margin in Locally Advanced Breast Cancer	NCT04418089	Breast Cancer Chemotherapy Ef...	Simvastatin 40m... Placebo oral ca...	-	Indonesia University
Effects of Simvastatin on Uterine Leiomyoma Size	NCT03400826	Fibroid Uterus Fibroid Tumor Leiomyoma Fibromyoma Leiomyoma, Uter...	Simvastatin 40m... Placebo 40 mg	18 Years - 55 Years	Johns Hopkins University
The Role of Simvastatin in The Epithelial-Mesenchymal Transition Process of Breast Cancer	NCT05550415	Triple Negative... Chemotherapy Ef... Simvastatin Adv...	Simvastatin 40m... Placebo	18 Years -	Indonesia University
Statin Therapy to Reduce Progression in Women With Platinum Sensitive Ovarian Cancer	NCT04457089	Recurrent Ovari... Platinum-sensit...	Simvastatin 40m...	18 Years -	Cedars-Sinai Medical Center

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