drugset / Trial / NCT03179904

TVB-2640 and Trastuzumab With Paclitaxel or Endocrine Therapy for Treatment of HER2 Positive Metastatic Breast Cancer

NCT03179904

Phase 2 Completed 17 enrolled Mayo Clinic
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This phase II trial studies how well FASN inhibitor TVB-2640, paclitaxel, and trastuzumab work in treating patients with HER2 positive breast cancer that has spread to other places in the body (metastatic). FASN inhibitor TVB-2640 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Trastuzumab is a form of targeted therapy because it attaches itself to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors. When trastuzumab attaches to HER2 receptors, the signals that tell the cells to grow are blocked and the cancer cell may be marked for destruction by the body's immune system. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Estrogen can cause the growth of breast cancer cells. Drugs used in endocrine therapy either lower the amount of estrogen made by the body or blocks the use of estrogen by the tumor cells. This may help stop the growth of tumor cells that need estrogen to grow. Giving FASN inhibitor TVB-2640 and trastuzumab in combination with paclitaxel or endocrine therapy may help control the disease in patients with HER2 positive breast cancer.

Timeline

Start
2017-08-03
Primary completion
2024-07-30
Completion
2026-03-13

Drugs

EvaluationDrugModalityDoseRoute
Subject Anastrozole Other / unclassified Oral
Subject Denifanstat Small molecule Oral
Subject Exemestane Small molecule Oral
Subject Fulvestrant Small molecule Intramuscular
Subject Letrozole Other / unclassified Oral
Subject Paclitaxel Small molecule Intravenous
Subject Trastuzumab Monoclonal antibody Intravenous