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

ClinicalTrials.gov ID: NCT03179904

Public ClinicalTrials.gov record NCT03179904. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID: NCT03179904
Recruitment status: Completed
Study type: Interventional
Phase: Phase 2
Lead sponsor: Mayo Clinic; Other
Enrollment: 17 participants

Conditions and interventions

Conditions

Interventions

Drug · Procedure · Biological

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Aug 2, 2017
Primary completion: Jul 29, 2024
Completion: Mar 12, 2026
Last update posted: Jun 30, 2026

2017 – 2026

United States locations

U.S. sites: 3
U.S. states: 3
U.S. cities: 3

Facility	City	State	ZIP	Site status
Mayo Clinic in Arizona	Scottsdale	Arizona	85259	—
Mayo Clinic in Florida	Jacksonville	Florida	32224-9980	—
Mayo Clinic in Rochester	Rochester	Minnesota	55905	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT03179904, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jun 30, 2026 · Synced Sep 2, 2026

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The complete protocol, eligibility criteria, and contact information for NCT03179904 live on ClinicalTrials.gov.

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