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Estrogen Receptor Antagonist

Tucatinib + Trastuzumab for HER2-Positive Cancers

Phase 2
Waitlist Available
Research Sponsored by Seagen Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Disease progression during or after, or intolerance of, the most recent line of systemic therapy
Participants with non-squamous NSCLC must have progressed during or after standard treatment or for which no standard treatment is available
Must not have
History of exposure to a 360 mg/m² doxorubicin-equivalent or >720 mg/m^2 epirubicin-equivalent cumulative dose of anthracyclines
Participants with breast cancer, gastric or gastroesophageal junction adenocarcinoma, or CRC whose disease shows HER2 amplification/overexpression
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from start of treatment up to approximately 4 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is for people with solid tumors that make too much HER2 or a different type of HER2. Participants will get tucatinib and trastuzumab. People with hormone-receptor positive breast cancer will also get fulvestrant. The trial will look at side effects.

Who is the study for?
This trial is for adults with advanced solid tumors that have HER2 alterations and have worsened after treatment, or can't be surgically removed. They must have an ECOG performance status of 0 or 1 (fully active or restricted in physically strenuous activity but ambulatory), measurable disease, and specific types of non-small cell lung cancer (NSCLC). Those with certain breast cancers are excluded, as well as anyone previously treated with HER2-targeted therapy unless specified.
What is being tested?
The study tests the effectiveness of tucatinib combined with trastuzumab on various solid tumors with abnormal HER2 production. Patients with hormone-receptor positive breast cancer will also receive fulvestrant. The goal is to see how these drugs work together against different tumor types that are either metastatic or unresectable.
What are the potential side effects?
Potential side effects include reactions related to drug infusion, allergic responses to ingredients in the medications, heart issues due to past treatments like anthracyclines, and general side effects such as fatigue, nausea, diarrhea which commonly occur during cancer therapies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My condition worsened or I couldn't tolerate my last cancer treatment.
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My non-squamous NSCLC has worsened despite treatment or lacks a standard treatment option.
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My cancer has worsened after at least one treatment for advanced or metastatic disease.
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My cancer shows HER2 changes, confirmed by a certified lab.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My cancer is advanced, cannot be surgically removed, or has spread, including to the brain.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been exposed to high doses of specific chemotherapy drugs.
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My cancer is HER2 positive.
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I haven't had cancer treatment or major surgery in the last 3 weeks and am not in another trial.
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I am not allergic to tucatinib, trastuzumab, or fulvestrant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from start of treatment up to approximately 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from start of treatment up to approximately 4 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
Confirmed objective response rate (cORR) per investigator assessment
Secondary study objectives
Disease control rate (DCR) per investigator assessment
Duration of response (DOR) per investigator assessment
Incidence of adverse events (AEs)
+5 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Tucatinib + Trastuzumab (+ Fulvestrant)Experimental Treatment3 Interventions
Tucatinib + trastuzumab (+ fulvestrant in hormone-receptor positive HER2-mutant breast cancer only)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
tucatinib
2021
Completed Phase 3
~810
trastuzumab
2002
Completed Phase 3
~1790
fulvestrant
2012
Completed Phase 3
~2000

Find a Location

Who is running the clinical trial?

Seagen Inc.Lead Sponsor
210 Previous Clinical Trials
74,071 Total Patients Enrolled
Jorge Ramos, DOStudy DirectorSeagen Inc.
4 Previous Clinical Trials
1,199 Total Patients Enrolled

Media Library

Fulvestrant (Estrogen Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT04579380 — Phase 2
Biliary Tract Cancer Research Study Groups: Tucatinib + Trastuzumab (+ Fulvestrant)
Biliary Tract Cancer Clinical Trial 2023: Fulvestrant Highlights & Side Effects. Trial Name: NCT04579380 — Phase 2
Fulvestrant (Estrogen Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04579380 — Phase 2
~46 spots leftby Nov 2025
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