Tucatinib + Trastuzumab for HER2-Positive Cancers
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the effectiveness of a drug combination, including tucatinib (a targeted therapy) and trastuzumab (also known as Herceptin, a monoclonal antibody therapy), against certain aggressive cancers that have spread or cannot be surgically removed. It targets tumors with changes in the HER2 protein, a condition present in various solid tumors. Participants with hormone-receptor positive breast cancer will also receive fulvestrant (also known as Faslodex, a hormone therapy). The trial will evaluate the combined effectiveness of these drugs and monitor any side effects. It seeks participants whose cancer has progressed after previous treatments and who have HER2 changes, excluding those who have received certain prior treatments. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop your current medications. However, you cannot have had any systemic anti-cancer therapy, radiation, major surgery, or experimental treatment within 3 weeks before starting the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that patients generally tolerate the combination of tucatinib and trastuzumab well. The most common side effect is diarrhea, while serious side effects like vomiting and nausea occur in less than 3% of patients.
This combination treats adults with HER2-positive breast cancer, where cancer cells have an excess of the HER2 protein that promotes growth. These findings suggest that many patients can manage these side effects effectively.
Trastuzumab is a well-known treatment, approved by the FDA for various HER2-positive cancers, which reassures its safety.
In this trial, some patients will also receive fulvestrant. Although specific safety data for this combination is not highlighted, each drug has a proven safety record in similar situations. Overall, evidence supports that these treatments are generally safe with manageable side effects.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the treatment combining Tucatinib and Trastuzumab for HER2-positive cancers because it targets the cancer cells in a unique way. Unlike traditional chemotherapy, which affects both cancerous and healthy cells, this combination focuses specifically on the HER2 protein, which is overexpressed in some breast cancers. Tucatinib is known for its ability to penetrate the brain, making it particularly promising for treating brain metastases, a common complication in HER2-positive breast cancer. Additionally, when paired with Fulvestrant, this treatment could offer a targeted approach for hormone-receptor positive HER2-mutant breast cancers, potentially leading to more effective and personalized treatment options.
What evidence suggests that tucatinib and trastuzumab could be effective for HER2-positive cancers?
Research has shown that using tucatinib and trastuzumab together is promising for patients with HER2-positive cancers. Studies have found that this combination can help patients live longer and control cancer that has spread to the brain. In this trial, participants will receive tucatinib and trastuzumab, and those with hormone-receptor positive HER2-mutant breast cancer will also receive fulvestrant. Tucatinib, typically used with trastuzumab, has proven effective for individuals with advanced or difficult-to-treat cancers. Adding fulvestrant has shown benefits in past treatments for hormone-receptor positive breast cancer. This combination targets and stops cancer cells from growing.678910
Who Is on the Research Team?
Pfizer CT.gov Call Center
Principal Investigator
Pfizer
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive tucatinib and trastuzumab, with fulvestrant for hormone-receptor positive breast cancer
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Fulvestrant
- Trastuzumab
- Tucatinib
Trial Overview
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.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Tucatinib + trastuzumab (+ fulvestrant in hormone-receptor positive HER2-mutant breast cancer only)
Fulvestrant is already approved in European Union, United States, Canada, Japan for the following indications:
- Hormone receptor-positive metastatic breast cancer
- Locally advanced breast cancer
- Hormone receptor-positive metastatic breast cancer
- Locally advanced breast cancer
- Hormone receptor-positive metastatic breast cancer
- Locally advanced breast cancer
- Hormone receptor-positive metastatic breast cancer
- Locally advanced breast cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Seagen, a wholly owned subsidiary of Pfizer
Lead Sponsor
Seagen Inc.
Lead Sponsor
Dr. Roger Dansey
Seagen Inc.
Chief Medical Officer since 2018
MD from University of Witwatersrand
David R. Epstein
Seagen Inc.
Chief Executive Officer since 2022
BSc in Pharmacy from Rutgers University, MBA from Columbia University
Citations
TUKYSA Combination Significantly Improves Progression ...
TUKYSA is approved in combination with trastuzumab and capecitabine to treat adults with HER2-positive advanced unresectable or metastatic ...
Advancing treatment in HER2-positive metastatic breast ...
The HER2CLIMB trial showed that tucatinib improves survival and helps control cancer in the brain. Other studies confirmed its effectiveness and ...
Tucatinib and trastuzumab in HER2-mutated metastatic ...
The study included a cohort of 31 heavily pretreated female patients with HER2-mutated metastatic breast cancer who were also HER2 negative per ...
Real-world treatment patterns and clinical outcomes with ...
To describe real-world characteristics and clinical outcomes among patients with HER2+ MBC receiving tucatinib-based treatments.
TUKYSA® (tucatinib) 2L+HER2+ MBC Efficacy - Safety Info
View efficacy data for the TUKYSA® (tucatinib) Rx regimen, in combination with trastuzumab plus capecitabine. Read full indication and important safety ...
Safety Info for TUKYSA® (tucatinib) in 2L+ HER2+ MBC
Serious adverse reactions occurring in ≥2% of patients in the TUKYSA arm#. Any reaction: 26% (diarrhea, 4.0%; vomiting, 2.5%; nausea, 2.0%; abdominal pain, ...
About TUKYSA® (tucatinib) for HER2+ MBC - Safety Info
The most common side effects of TUKYSA in combination with trastuzumab and capecitabine in adults with HER2-positive breast cancer include: • diarrhea.
TUKYSA® (tucatinib) tablets, for oral use - accessdata.fda.gov
TUKYSA is indicated in combination with trastuzumab for the treatment of adult patients with RAS wild-type,. HER2-positive unresectable or metastatic colorectal ...
NCT02025192 | A Study of Tucatinib (ONT-380) Combined ...
A Study of Tucatinib (ONT-380) Combined With Capecitabine and/or Trastuzumab in Patients With HER2+ Metastatic Breast Cancer. ClinicalTrials.gov ID NCT02025192.
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targetedonc.com
targetedonc.com/view/safety-of-tucatinib-triplet-for-her2-breast-cancer-sealed-in-real-world-analysisSafety of Tucatinib Triplet for HER2+ Breast Cancer ...
Findings from the HER2CLIMB clinical trial of tucatinib combined with trastuzumab and capecitabine verified the safety of the regimen in patients with HER2- ...
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