drugset / Trial / NCT03872388

Atorvastatin in Treating Patients With Stage IIb-III Triple Negative Breast Cancer Who Did Not Achieve a Pathologic Complete Response After Receiving Neoadjuvant Chemotherapy

NCT03872388

Non-randomizedParallel-groupOpen-labelTreatment

Summary

This phase II trial studies how well atorvastatin works in treating patients with stages IIb-III triple negative breast cancer who did not achieve a pathologic complete response to neoadjuvant chemotherapy. Pathologic complete response is the lack of all signs of cancer in tissue samples removed during surgery after upfront chemotherapy. Atorvastatin is used for the treatment of high cholesterol and may reduce the risk of triple negative breast cancer from coming back. Triple-negative breast cancer is a type of breast malignancy that is comprised of cancer cells that do not have estrogen receptors, progesterone receptors, or large amounts of HER2/neu protein. Patients with TNBC do not have established systemic therapies such as anti-estrogens or HER2-targeting agents to reduce recurrence after surgery, and residual cancer found at surgery is associated with higher relapse rate.

Timeline

Start
2019-09-23
Primary completion
2023-10-19
Completion
2023-10-19

Drugs

EvaluationDrugModalityDoseRoute
Subject Atorvastatin Small molecule 20 mg Oral
Subject Atorvastatin Small molecule 80 mg Oral
Comparator Capecitabine Small molecule 2500 mg/m2