Status:
COMPLETED
Simvastatin Effect in Combination With Neoadjuvant Chemotherapy to Clinical Response and Tumor-Free Margin in Locally Advanced Breast Cancer
Lead Sponsor:
Indonesia University
Conditions:
Breast Cancer
Chemotherapy Effect
Eligibility:
FEMALE
Phase:
PHASE2
Brief 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 7...
Detailed Description
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 u...
Eligibility Criteria
Inclusion
- LABC IIIA-IIIC TNM / AJCC 2018 with histopathological examination.
- Patients are planned to get NACT
- Performance status of Eastern Cooperative Oncology Group (ECOG) 0-2.
- LABC patients who have not received surgery, radiation or systemic therapy and previous statin therapy.
- Normal kidney organ function (serum creatinine ≤ 1.5 upper limit normal).
- Normal liver organ function (ALT ≤ 2 times the normal limit, or total bilirubin level ≤ 1.5 times the normal upper limit)
- Heart function (E / F)\> 55%
- Willing to participate in this study by signing an informed consent
Exclusion
- LABC patients are both residual and recurrent.
- Allergy to tattoo ink
- Allergy to statins
- Patients are pregnant or breastfeeding
Key Trial Info
Start Date :
January 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 5 2019
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04418089
Start Date
January 15 2018
End Date
September 5 2019
Last Update
June 5 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Faculty of Medicine, Universitas Indonesia
Jakarta Pusat, DKI Jakarta, Indonesia, 10430