OncRef

Clinical Trial: NCT03179904

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

Status:

COMPLETED

Phase:

Phase 2

Lead Sponsor:Mayo Clinic
Information Provided By:Mayo Clinic
Last Update Posted:2026-10-09

Study Overview

Brief 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.

Official Title

MC1633 Phase II Trial to Evaluate the Efficacy of the FASN Inhibitor, TVB-2640, in Combination With Trastuzumab Plus Paclitaxel or Endocrine Therapy in Patients With HER2+ Metastatic Breast Cancer Resistant to Trastuzumab-Based Therapy

Conditions

Advanced Breast Carcinoma, HER2-Positive Breast Carcinoma, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, HER2-positive Breast Cancer

Intervention / Treatment

  • Drug: Anastrozole
  • Drug: Denifanstat
  • Drug: Exemestane
  • Drug: Fulvestrant
  • Procedure: Echocardiography
  • Drug: Letrozole
  • Drug: Paclitaxel
  • Biological: Trastuzumab
  • Procedure: Computed Tomography
  • Procedure: Magnetic Resonance Imaging
  • Procedure: Biospecimen Collection
  • Procedure: Biopsy

Other Study ID Numbers

  • MC1633
  • W81XWH-16-1-0269
  • W81XWH-16-1-0268
  • 16-010066

Start Date (Actual)

2017-08-03

Primary Completion Date (Actual)

2024-07-30

Study Completion Date (Actual)

2026-03-13

Enrollment (Actual)

17

Study Type

Interventional

Phase

Phase 2