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Search / Trial NCT05550415

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

Launched by INDONESIA UNIVERSITY · Sep 19, 2022

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Vimentin Simvastatin Epithelial Mesenchymal Transition Neoadjuvant Chemotherapy Clinical Response Pathological Response

ClinConnect Summary

This clinical trial is studying the effects of a medication called simvastatin in combination with standard chemotherapy for women with a specific type of breast cancer known as triple-negative breast cancer (TNBC). TNBC is known to be aggressive and can be challenging to treat. The researchers want to see if simvastatin can help improve the treatment response by affecting a process called epithelial-mesenchymal transition (EMT), which is linked to how cancer spreads and can make it harder for treatments to work.

To participate in this trial, women must be over 18 years old and have been diagnosed with advanced triple-negative breast cancer confirmed by a biopsy. They should also be planning to receive eight cycles of a specific chemotherapy regimen. Participants will be randomly assigned to receive either simvastatin along with their chemotherapy or a placebo (a harmless pill with no active ingredients). Throughout the trial, researchers will monitor any side effects and check how well the treatment is working by looking at tissue samples from biopsies taken before and after the treatment. If you or someone you know is considering joining this trial, it could be a chance to contribute to important research while receiving treatment.

Gender

FEMALE

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.

About Indonesia University

Indonesia University is a leading academic institution dedicated to advancing healthcare through rigorous clinical research. As a trial sponsor, the university leverages its extensive expertise in medical science and collaboration with top-tier researchers to design and implement innovative clinical trials. Committed to ethical standards and patient safety, Indonesia University aims to contribute to the global body of knowledge in medicine, enhance therapeutic options, and improve health outcomes for diverse populations. Through its comprehensive approach, the university fosters an environment of scientific inquiry and collaboration, driving progress in clinical research and education.

Locations

Jakarta Pusat, Dki Jakarta, Indonesia

Patients applied

0 patients applied

Trial Officials

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

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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