Clinical trial · Interventional
Possible Protective Effect of Rosuvastatin in Chemotherapy-induced Cardiotoxicity in HER2 Positive Breast Cancer Patients
NCT05338723CI-TRIAL-00074459completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study aims to investigate the possible role of rosuvastatin in protection against cardiotoxicity in HER2 positive breast cancer patients receiving doxorubicin sequential with trastuzumab.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Chemotherapy-induced Cardiotoxicity | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Rosuvastatin 20mg | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- control-group
- description
- This group will include 25 patients who will receive doxorubicin for 4 cycles (3 months) followed by trastuzumab adjuvant therapy.
- type
- ACTIVE_COMPARATOR
- label
- rosuvastatin-group
- description
- This group will include 25 patients who will receive doxorubicin for 4 cycles (3 months) followed by trastuzumab adjuvant therapy in addition to 20 mg of oral rosuvastatin 24 hours prior to the first cycle of chemotherapy and once daily for the rest of the follow-up period (6 months).
- interventionNames
- Drug: Rosuvastatin 20mg
Primary outcomes (1)
- measure
- change in left ventricular ejection fraction(LVEF) detected by electrocardiography transthoracic echocardiography
- timeFrame
- 6 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Age: 25-75 years old. * Gender: female * Newly diagnosed HER2 positive breast cancer patients who are scheduled to receive doxorubicin followed by trastuzumab adjuvant therapy. * Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2 * Preserved LV systolic function in which the left ventricular ejection fraction (LVEF)≥50%. * Patients with normal renal and hematological functions. * Alanine amino transferase (ALT ≤ 3 times ULN). Exclusion Criteria: * Pregnant or lactating females. * Eastern Cooperative Oncology Group (ECOG) performance status (PS) \> 2 * Patients with impaired LV systolic function in which the left ventricular ejection fraction (LVEF)\<50%. * Patients with significant valvular heart disease, documented coronary artery disease, history of congestive heart failure or cardiomyopathy. * Alanine amino transferase (ALT \> 3 times ULN). * Patients already taking statins or other lipid lowering therapy. * Patients with a known hypersensitivity to any of the used drugs.
References
Publications (0)
Data not yet available
No reference posted for this study.