Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Phase II trial of trastuzumab deruxtecan in first-line treatment HER2-positive locally advanced or metastatic breast cancer (MBC) patients considered resistant to trastuzumab + pertuzumab + taxane due to early relapse. “TRANSCENDER Study”

The TRANSCENDER study is a clinical trial focusing on a new medicine called trastuzumab deruxtecan (DS-8201a). This study is for people with advanced breast cancer (HER2-positive) that has spread to other parts of the body or is locally advanced. It specifically targets patients whose cancer has returned relatively quickly after receiving the usual first-line treatments like trastuzumab, pertuzumab, and a taxane. The main goal of this study is to find out how effective this new treatment is at shrinking or stopping the growth of the cancer. Researchers will also be looking at how long people live, how long they live without their cancer getting worse, and any side effects the treatment might cause. This is a Phase II study, meaning it's exploring the treatment's effectiveness and safety in a larger group of patients.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Grupo Espanol De Investigacion En Cancer De Mama

Enrolment target

Start

18 Aug 2023

Metastatic breast cancer

What is this study about?

The TRANSCENDER study is a clinical trial that explores a new treatment for a specific type of breast cancer. This study is aimed at people who have HER2-positive breast cancer that has spread to other parts of the body (called metastatic) or is locally advanced. This is often a more serious form of the disease. Sometimes, despite receiving standard first-line treatments, such as trastuzumab, pertuzumab, and a taxane, the cancer can return quickly. When this happens, doctors need other options, and that's where studies like TRANSCENDER come in.

This study is testing a new medicine called trastuzumab deruxtecan, also known as DS-8201a. The main aim is to see how well this new treatment works in shrinking the cancer or stopping its growth. Researchers will be looking at how many patients see their cancer shrink (called the 'objective response rate'). This will give them a good idea of whether the drug is effective for patients whose cancer has been resistant to other treatments.

Beyond simply shrinking the cancer, the study will also look at other important things. This includes how long patients live without their cancer getting worse, and how long they live overall. They'll also carefully track any side effects people might experience to understand how safe the treatment is and how well patients can tolerate it. Ultimately, the hope is that this study will provide valuable information about a new treatment option for patients with this challenging form of breast cancer.

Key takeaways

Tests a new drug (trastuzumab deruxtecan) for advanced HER2-positive breast cancer.
For patients whose cancer returned quickly after initial standard treatments.
Aims to see how well the new drug shrinks the cancer.
Also looking at how long patients live and any side effects.
Open to adults aged 18 and older, both men and women.

Who may be eligible?

To be considered for the TRANSCENDER study, you need to meet certain requirements. This study is for adults, meaning you must be 18 years old or older. There is no upper age limit for participating.

It's important that you have been diagnosed with HER2-positive breast cancer that has either spread to other parts of your body (metastatic) or is locally advanced. A key part of qualifying for this study is that your cancer must have come back relatively soon after you received treatment with trastuzumab, pertuzumab, and a taxane. This suggests your cancer might be resistant to those standard treatments.

Both men and women can take part in this study, provided they meet all the other medical criteria. Your study doctor will review your full medical history and perform additional tests to ensure this study is a suitable option for you.

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.

Are you 18 years old or older?
Have you been diagnosed with HER2-positive breast cancer that has spread or is locally advanced?
Did your cancer return relatively quickly after receiving trastuzumab, pertuzumab, and a taxane?
Are you able to travel to the study clinic for regular appointments?

Answer every question to see your result.

What does participation involve?

If you join the TRANSCENDER study, you would receive the study drug, trastuzumab deruxtecan (DS-8201a). This medication is given through an IV (into a vein) at regular intervals. You would have frequent visits to the clinic for assessments.

These assessments include regular scans (like CT or MRI) to check the size of your cancer, blood tests to monitor your general health and look for side effects, and physical exams by the study doctor. You'll also be asked questions about how you are feeling and any side effects you might be experiencing. They will also ask you to complete questionnaires about your quality of life. The study will continue for as long as the treatment is helping you and you are tolerating it well. You will have regular follow-up even after you stop the study treatment.

Potential risks and benefits

Taking part in a clinical trial like TRANSCENDER might offer you access to a new treatment before it's widely available. The potential benefit is that this new treatment might help shrink your cancer or slow its growth, especially if standard treatments haven't worked well for you. However, there are also potential risks; all medications can have side effects, and the new treatment might cause unexpected or serious reactions. Your doctors will carefully monitor you for these. You have the right to withdraw from the study at any time, for any reason, without affecting your future medical care.

Locations (1)

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

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Unverified
Spain

Common questions

What type of cancer is this study for?

This study is for HER2-positive breast cancer that has spread or is locally advanced, in patients whose cancer came back quickly after standard treatments.

What is HER2-positive breast cancer?

HER2-positive breast cancer means the cancer cells have a particular protein called HER2 on their surface. This protein helps the cancer grow, and treatments can be targeted to it.

What does 'first-line treatment' mean?

First-line treatment refers to the initial, standard treatment given for a specific condition. In this study, it refers to trastuzumab, pertuzumab, and a taxane.

What is trastuzumab deruxtecan (DS-8201a)?

It's the new experimental drug being tested in this study, aimed at treating HER2-positive breast cancer.

Why is this study called a 'Phase II' study?

Phase II studies explore if a new treatment is effective and safe in a larger group of people after initial safety tests in Phase I. They help decide if further research is needed.