CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 17 enrolled
Drug / intervention
Anastrozole +11 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03179904
NCT03179904Phase 2Active

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

Mayo Clinic·interventional·Posted Jun 7, 2017·Updated May 5, 2026

In Brief

A Phase 2 clinical trial evaluating Anastrozole, Denifanstat, and 10 other interventions for Advanced Breast Carcinoma and 4 related conditions. Active but no longer recruiting, targeting 17 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2ActiveOverdue
201820192020202120222023202420252026
First PostedJun 7, 2017
Enrollment StartAug 3, 2017
Primary CompletionJul 30, 2024
Study CompletionJun 13, 2026
TodayJul 2, 2026
Enrollment to primary: 7.0 yearsPosted 9.1 years ago

Interventions

Anastrozoledrug

Given PO

Denifanstatdrug

Given PO

Exemestanedrug

Given PO

Fulvestrantdrug

Given IM

Echocardiographyprocedure

Undergo ECHO

Letrozoledrug

Given PO

Paclitaxeldrug

Given IV

Trastuzumabbiological

Given IV

Computed Tomographyprocedure

Undergo CT

Magnetic Resonance Imagingprocedure

Undergo MRI

Biospecimen Collectionprocedure

Undergo blood sample collection

Biopsyprocedure

Undergo biopsy