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FASN Inhibitor

FASN Inhibitor + Trastuzumab for Breast Cancer

Phase 2

Waitlist Available

Led By Tufia C Haddad

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Calculated creatinine clearance >= 45 ml/min using the Cockcroft-Gault formula

Received =< four (4) prior chemotherapy regimens in the metastatic setting

Must not have

Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy

Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying 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).

Who is the study for?

This trial is for adults with HER2 positive metastatic breast cancer. Participants must have good liver and kidney function, a stable heart condition, no severe allergies to the drugs being tested, and not be pregnant or breastfeeding. They should have received fewer than four chemotherapy treatments in the metastatic setting and agree to use contraception.

What is being tested?

The study tests if TVB-2640 (a FASN inhibitor), combined with trastuzumab and either paclitaxel (chemotherapy) or endocrine therapy, can effectively treat HER2 positive metastatic breast cancer by blocking enzymes needed for cell growth and targeting specific receptors on cancer cells.

What are the potential side effects?

Potential side effects include reactions related to immune system activation such as inflammation of organs, infusion-related reactions from trastuzumab, typical chemotherapy side effects like fatigue, nausea, hair loss from paclitaxel; hormonal changes due to endocrine therapy may also occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidneys are functioning well enough, based on a specific test.

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I have had 4 or fewer chemotherapy treatments for my cancer after it spread.

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I am fully active or can carry out light work.

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My breast cancer is confirmed to be HER2-positive.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am immunocompromised or HIV positive and on antiretroviral therapy.

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I am not on any experimental drugs for my cancer.

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I cannot swallow pills or have a digestive system condition.

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I have not had any other cancer besides this one in the last 3 years.

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I have had a heart attack in the last 6 months or have heart failure needing constant treatment.

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I have been diagnosed with unstable chest pain.

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I do not have spreading cancer in the brain or spinal cord.

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My cancer affects my spinal cord or heart.

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My cancer has not spread to my internal organs in a life-threatening way.

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I am not pregnant, nursing, or if capable of childbearing, I am using effective contraception.

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I have had serious heart rhythm problems that needed treatment.

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I have a history of severe dry eye or other eye surface issues.

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I have a serious illness that is not related to my heart.

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I stopped taking trastuzumab because it affected my heart.

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I have heart failure, regardless of its classification.

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My high blood pressure is not controlled by medication.

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My heart function dropped below 50% due to cancer treatment within the last 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall response rate

Secondary study objectives

Clinical benefit rate

Duration of response

Progression free survival

Other study objectives

Changes in biomarker expression

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort B (TVB-2640, trastuzumab, endocrine therapy)Experimental Treatment11 Interventions

Patients receive FASN inhibitor TVB-2640 PO QD on days 1-28 and trastuzumab IV over 30-90 minutes on days 1, 8, 15, and 22 and optionally every 21 days after 3 cycles and paclitaxel is discontinued. Patients also continue endocrine therapy of either anastrozole PO QD, exemestane PO QD, fulvestrant IM on days 1 and 14 of cycle 1 and day 1 of subsequent cycles, or letrozole PO QD. Cycles repeat every 28 days in the absence of disease progression or unexpected toxicity. Patients also undergo ECHO and CT or MRI at screening and on study and undergo collection of blood samples and biopsy on study.

Group II: Cohort A (FASN inhibitor TVB-2640, paclitaxel, trastuzumab)Experimental Treatment8 Interventions

Patients receive FASN inhibitor TVB-2640 PO QD on days 1-28, paclitaxel IV over 1-96 hours on days 1, 8, and 15, and trastuzumab IV over 30-90 minutes on days 1, 8, 15, and 22 and optionally every 21 days after 3 cycles and paclitaxel is discontinued. Cycles repeat every 28 days in the absence of disease progression or unexpected toxicity. Patients also undergo ECHO and CT or MRI at screening and on study and undergo collection of blood samples and biopsy on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Paclitaxel

2011

Completed Phase 4

~5450

Echocardiography

2013

Completed Phase 4

~11580