Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Targeting non-Luminal disease by PAM50 with pembrolizumab + paclitaxel in Hormone Receptor-positive/HER2-negative advanced/metastatic breast cancer, who have progressed on or after CDK 4/6 inhibitor treatment (TATEN trial)

This study, called TATEN, is for women with a specific type of advanced breast cancer (HR+/HER2-negative) that has continued to grow after earlier treatments, including a type called CDK 4/6 inhibitors. Researchers are testing a combination of two drugs, pembrolizumab (also known as KEYTRUDA) and paclitaxel. They want to see how effective this new treatment is at shrinking the cancer. This is a Phase II study, meaning it’s an early step to find out if the treatment is promising before testing it on more people. The main goal is to measure how many patients see their tumours shrink or disappear.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Solti Group

Enrolment target

Start

11 Dec 2023

Pre and post-menopausal women with locally advanced or metastatic HR+/HER2-negative endocrine resistant breast cancer

What is this study about?

This research study, called TATEN, is investigating a new treatment approach for a type of breast cancer that has spread or come back, and has not responded well to standard treatments. Specifically, it's for women whose breast cancer is described as 'Hormone Receptor-positive' (HR+) and 'HER2-negative' and has continued to grow even after they've had a type of treatment called a CDK 4/6 inhibitor. These terms simply describe certain features of the cancer cells that doctors use to guide treatment decisions.

The study combines two medications: pembrolizumab (known commercially as KEYTRUDA) and paclitaxel. Pembrolizumab is an immunotherapy, which works by helping your own immune system fight the cancer. Paclitaxel is a type of chemotherapy that stops cancer cells from growing. By combining these, doctors hope to find a more effective way to control the cancer’s growth. This is a 'Phase II' trial, which means it’s an early-stage study designed to see if the treatment is safe and shows enough promise to be studied in a larger group of people later on.

The main thing researchers want to find out is how many patients experience their tumours shrinking or disappearing — this is called the 'Overall Response Rate'. They will also look at how long people live without their cancer getting worse, how long the treatment keeps the cancer under control, and how long people live in total. All these measurements help doctors understand if the new treatment is a significant improvement for patients facing this challenging form of breast cancer.

Key takeaways

This study is for women with advanced HR+/HER2-negative breast cancer that has progressed on previous treatments.
It tests a new combination of immunotherapy (pembrolizumab) and chemotherapy (paclitaxel).
The main goal is to measure how many patients see their tumours shrink or disappear.
This is an early-stage (Phase II) study to check if the new treatment is safe and effective.
Participants will receive regular treatments and check-ups with scans and blood tests.

Who may be eligible?

This study is looking for women who have been diagnosed with a specific type of advanced or metastatic breast cancer. 'Locally advanced' means the cancer has grown into nearby tissues, while 'metastatic' means it has spread to other parts of the body. Your cancer must be HR-positive and HER2-negative, which are specific characteristics that your doctors will have identified from your biopsy results.

Critically, your cancer must be considered 'endocrine resistant'. This means that previous hormone-based treatments, like those targeting HR+ breast cancer, haven't been able to stop the cancer from growing. You must have also already received and progressed on or after a type of treatment called a CDK 4/6 inhibitor, even if that treatment initially worked.

This study includes both women who are still having periods (pre-menopausal) and those who have gone through menopause (post-menopausal). You need to be at least 18 years old to take part. Your doctor will carefully check all your medical history and test results to see if this study is right 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 a woman with advanced (locally advanced or metastatic) breast cancer?
Has your doctor told you your cancer is HR-positive and HER2-negative?
Has your cancer continued to grow despite previous hormone treatments?
Have you already received and progressed on or after a CDK 4/6 inhibitor treatment?
Are you 18 years of age or older?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive regular appointments at the hospital. These appointments will involve getting infusions of the study drugs, pembrolizumab and paclitaxel, which are given into a vein. You will also have regular tests, such as blood tests and scans, to monitor your health and see how the treatment is affecting your cancer. These scans will help doctors measure if your tumours are shrinking. The medical team will closely watch you for any side effects from the drugs.

The study will involve follow-up visits and assessments over a period of time to track your progress. The total length of your participation will depend on how you respond to the treatment and your overall health, but the study will continue to monitor your health for a long time, potentially even after you stop receiving the study drugs, to see how you are doing.

Potential risks and benefits

Participating in a clinical trial offers the potential benefit of access to a new treatment before it's widely available, which might be helpful if standard treatments haven't worked for you. However, there are also risks. The experimental drugs, like all medicines, can have side effects, and these could be unpleasant or serious. Not everyone responds to new treatments, and it's possible the study treatment may not help your cancer. It's very important to remember that you can choose to leave the study at any time, for any reason, without it 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 does 'HR+/HER2-negative' mean?

This describes specific features of your breast cancer cells that help doctors decide which treatments might work best. HR+ means the cancer grows in response to hormones, and HER2-negative means it doesn't have high levels of another protein called HER2.

What are pembrolizumab and paclitaxel?

Pembrolizumab (KEYTRUDA) is an immunotherapy that helps your immune system fight cancer. Paclitaxel is a common chemotherapy drug that works by stopping cancer cells from dividing and growing.

What is a 'Phase II' study?

This is an early stage of research to see if a new treatment is safe and shows enough promise in a smaller group of people before potentially progressing to larger studies.

What does 'Overall Response Rate' mean for me?

This is how doctors measure if the treatment is shrinking your tumours. It means they will look at your scans to see if your cancer has become smaller or disappeared completely.

Can I stop participating in the study if I want to?

Yes, absolutely. You have the right to withdraw from the study at any time, for any reason, and your decision will not affect your future medical care.