MedTrace Logo

Simvastatin Effect in Combination With Neoadjuvant Chemotherapy to Clinical Response and Tumor-Free Margin in Locally Advanced Breast Cancer

NCT04418089 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-06-05

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Simvastatin 40mg

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

DRUG

Placebo oral capsule

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

Sponsors & Collaborators

  • Indonesia University

    lead OTHER

Principal Investigators

  • Nurjati Chairani Siregar, MD · Department of Pathology, Dr. Cipto Mangunkusumo General Hospital, Jakarta, Indonesia

  • Baju Adji · Department of Surgery, Koja General Hospital, Jakarta, Indonesia

  • Filipus Dasawala, MD · Department of Surgery, Dr. Cipto Mangunkusumo General Hospital, Jakarta, Indonesia

  • Hanifah Hasan, MD · Internship Program as Research Assistant, Department of Surgery, Dr. Cipto Mangunkusumo General Hospital, Jakarta, Indonesia

  • Muhammad Rizki Kamil, MD · Internship Program as Research Assistant, Department of Surgery, Dr. Cipto Mangunkusumo General Hospital, Jakarta, Indonesia

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-15
Primary Completion
2019-05-20
Completion
2019-09-05

Countries

  • Indonesia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04418089 on ClinicalTrials.gov