Active not recruitingPHASE2INTERVENTIONAL

Basket Study of Tucatinib and Trastuzumab in Solid Tumors With HER2 Alterations

This study investigates a new treatment approach for several types of advanced solid tumours that have changes in a gene called HER2. These changes mean the cancer cells either have too much HER2 or a different type of HER2 than usual. The study uses two drugs, tucatinib and trastuzumab, given together. For people with hormone-sensitive breast cancer, another drug called fulvestrant will also be given. The main aim is to see how effective this combination treatment is and to understand any side effects it might cause. The cancers included are those that have spread to other parts of the body or cannot be completely removed by an operation. It's a Phase 2 study, meaning it's still being tested but has shown some promise in earlier research.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Seagen, a wholly owned subsidiary of Pfizer

Enrolment target

217

Start

11 Jan 2021

Estimated completion

30 Apr 2026

Uterine Neoplasms Uterine Cervical Neoplasms Biliary Tract Neoplasms Urologic Neoplasms Carcinoma, Non-Small-Cell Lung HER2 Mutations Breast Neoplasms

Results

Results from this study

Posted November 2024

Results have been published for this study.

Primary outcome

Confirmed Objective Response Rate (cORR) as Assessed by Investigator

Confirmed ORR was defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version (v)1.1 as assessed by investigator and was considered as confirmed when subsequent response was at least 4 weeks after initial response. As per RECIST v1.1, CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<)10 millimeter (mm). PR: at least a greater than or equal to (\>=)30 % decrease in the sum of diameters (SOD) of target lesions (longest for non-nodal target lesions and the short axes for nodal target lesions), taking as reference the baseline sum diameters. Disease progression (PD): at least \>=20% relative increase in SOD of target lesion taking as reference the smallest sum on study (including baseline sum if that is the smallest on study).

Full results on the registry

What is this study about?

This study is exploring a new way to treat several different types of advanced cancers. When we say 'advanced', we mean cancers that have either spread to other parts of the body (this is called metastatic) or are too widespread to be completely removed with an operation. These cancers all have something in common: a specific change in a gene called HER2. This change can mean the cancer cells make too much of a protein called HER2, or they have a slightly different version of it. Targeting this HER2 change is a common way to treat some cancers, like certain types of breast cancer, but this study is looking at its effect in a wider range of solid tumours.

The main treatment being tested involves two drugs: tucatinib and trastuzumab. Patients in the study will receive both of these. For those with a specific type of breast cancer that is also sensitive to hormones, a third drug called fulvestrant will be added to this combination. The aim is to see if this treatment can shrink tumours or stop them from growing, and importantly, to understand any side effects people might experience. Side effects are any effects a medicine has other than its main intended purpose. Knowing about side effects helps doctors understand if a treatment is safe and tolerable.

This is a 'Phase 2' study, which means it builds on earlier research that suggested these drugs might be helpful. It's not a first-line treatment, but rather for people whose cancer has unfortunately progressed after previous treatments, or for whom standard treatments aren't available. By studying how these drugs work in different cancers with HER2 changes, researchers hope to find new, effective treatments for a broader group of patients.

Key takeaways

This study is for people with advanced solid cancers that have a HER2 gene change.
It uses a combination of two (or three for some breast cancers) specific anti-HER2 drugs.
It's a Phase 2 study, focusing on how well the treatment works and what side effects occur.
Participants must have tried other treatments already, or have no standard options available.
The study aims to find new treatment options for a wider range of cancers with HER2 changes.
Your health will be closely monitored throughout your participation.

Who may be eligible?

To join this study, you generally need to have an advanced solid tumour that has spread or can't be removed by surgery. This cancer must also show specific changes in the HER2 gene, meaning either too much HER2 protein is being made, or there's an unusual version of the gene. These HER2 changes must have been confirmed by a specific test.

Your cancer should also have progressed (grown or worsened) despite receiving at least one previous standard treatment for your advanced cancer. If you have a specific type of lung cancer (called non-squamous non-small cell lung cancer), you need to have already gone through standard treatments or not have any standard options left.

There are also some important reasons why you might not be able to join. For example, if you have certain types of breast, stomach, or bowel cancer with HER2 changes, you usually won't be eligible. Also, if you've had previous treatment that specifically targets HER2 (except for certain specific situations with trastuzumab), or if you are allergic to any of the study drugs, you wouldn't be able to take part. You also need to be well enough to take part, as assessed by your doctor.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do I have a solid cancer that has spread or can't be removed by surgery?
Has my cancer recently progressed after previous treatment (or are there no standard treatments left)?
Have tests shown that my cancer has a HER2 gene alteration (either too much HER2 or a mutated HER2 gene)?
Have I generally not received other HER2-targeted therapies before?
Am I feeling well enough to take part in a study, as my doctor would assess?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive the study drugs, tucatinib and trastuzumab. If you have hormone-receptor positive breast cancer, you will also receive fulvestrant. These drugs will be given regularly according to a schedule decided by the study doctors. You will have regular visits to the clinic for check-ups, scans to see how your tumour is responding, and blood tests to monitor your health and any side effects. You'll also be asked about any symptoms or side effects you might be experiencing. The exact number of visits and the total length of time you'll be in the study will depend on how your body responds to the treatment and the study plan, but typical cancer trials involve regular follow-ups for many months, and sometimes years. You will be closely monitored throughout the process.

Potential risks and benefits

Participating in a clinical trial offers potential benefits, such as access to new medications before they are widely available and close monitoring of your health by a medical team. However, there are also potential risks related to the study drugs, including side effects that may be mild or more serious, and there's no guarantee the treatment will work for you. It's important to understand that your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (106)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

HonorHealth
Verified postcode
Phoenix, United States
HonorHealth
Verified postcode
Tempe, United States
The University of Arizona Cancer Center-North Campus
Verified postcode
Tucson, United States
City of Hope at Huntington Beach
Verified postcode
Huntington Beach, United States
City of Hope at Irvine Sand Canyon
Verified postcode
Irvine, United States
Koman Family Outpatient Pavilion
Verified postcode
La Jolla, United States
UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion)
Verified postcode
La Jolla, United States
UC San Diego Moores Cancer Center- Investigational Drug Services
Verified postcode
La Jolla, United States
UC San Diego Moores Cancer Center
Verified postcode
La Jolla, United States
City of Hope at Long Beach Worsham
Verified postcode
Long Beach, United States
City of Hope at Long Beach Elm
Verified postcode
Long Beach, United States
City of Hope at Newport Beach Lido
Verified postcode
Newport Beach, United States

Common questions

What does 'HER2 alteration' mean?

It means your cancer cells have a change in a specific gene called HER2, which might make them grow differently. This could be having too much HER2 protein or a changed HER2 gene.

What is a 'solid tumour'?

A solid tumour is a mass of abnormal tissue that usually doesn't contain cysts or liquid areas. Most cancers are solid tumours.

What are tucatinib and trastuzumab?

They are types of targeted cancer drugs designed to specifically block the HER2 protein or the signals it sends, aiming to stop cancer cell growth. Trastuzumab is a well-known drug, while tucatinib is newer.

What is a 'Phase 2' study?

A Phase 2 study checks if a new treatment works and is safe in a larger group of people. It’s part of the process to find out if a new drug should be approved.

Will I get a placebo (dummy treatment)?

No, in this study, all participants will receive the active study drugs (tucatinib and trastuzumab, and possibly fulvestrant if applicable).