Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Combination of pembrolizumab with oral metronomic cyclophosphamide in patients with chest wall breast cancer (PERICLES): A phase II study

This research study, called PERICLES, is exploring a new treatment option for a specific type of breast cancer. It's for patients whose breast cancer has returned in the chest wall, can't be removed by surgery, or has spread to other areas. The study combines two medicines already used in cancer treatment: pembrolizumab (Keytruda) given through a drip, and cyclophosphamide (Endoxan) taken as a tablet. Researchers want to see how many patients respond to this combination, meaning their tumors shrink or disappear. This is a Phase II study, which focuses on whether a new treatment is effective and safe enough to move on to larger studies.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Istituto Europeo Di Oncologia S.r.l.

Enrolment target

Start

29 Jul 2024

Locally recurrent inoperable and/or metastatic inflammatory breast cancer with lymphangitic spread to the chest wall

What is this study about?

This study is called PERICLES, and it's looking into a new treatment for breast cancer that has either reappeared in the chest wall after previous treatment, is too widespread for surgery, or has shown signs of spreading through the lymph system in the chest. Researchers are trying a combination of two existing cancer drugs, pembrolizumab (also known as Keytruda) and cyclophosphamide (also known as Endoxan), to see if they work better together.

Pembrolizumab works by helping your body's immune system fight cancer cells, while cyclophosphamide is a chemotherapy drug that kills cancer cells. By combining these two medicines, the hope is to achieve a stronger effect against the cancer. The main goal of this particular study is to find out if this combination can make tumors shrink or disappear in patients with this type of breast cancer.

This is a 'Phase II' study, which means it's a step after initial safety tests. The researchers want to understand how effective this new combination therapy is for patients and to continue gathering information on its safety. The information from this study will help decide if this treatment should be investigated further in larger trials.

Key takeaways

New combination treatment for specific breast cancer.
Uses existing drugs: Keytruda (drip) and Endoxan (tablet).
Focuses on cancer in the chest wall or that has spread.
Aims to see if tumors shrink or disappear.
Open to adults aged 18 and older, both men and women.
Phase II study, checking effectiveness and safety.

Who may be eligible?

To be considered for this study, you would need to be an adult, aged 18 or older. Both men and women can potentially take part if they meet other specific health criteria.

The study is specifically designed for people who have breast cancer that has come back in their chest wall, can't be operated on, or has spread through the lymph vessels in the chest. This also includes certain types of inflammatory breast cancer.

It's important to remember that there are other health requirements that your doctor would need to check to make sure the study is a suitable and safe 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?
Do you have breast cancer that has come back in your chest wall?
Is your breast cancer considered 'inoperable' or has it spread?
Have you discussed your specific medical history with your doctor regarding this study?

Answer every question to see your result.

What does participation involve?

If you join this study, you would receive two different medicines: pembrolizumab, which is given through a drip into your vein (like an infusion), and cyclophosphamide, which you would take as a tablet. The study aims to see how your body responds to these medicines over time.

Taking part would involve regular visits to the hospital for your medication and to have tests. These tests might include scans to see how your cancer is changing, and blood tests to check your general health and how well you are tolerating the treatment. You will also have follow-up appointments to track your progress.

The total length of time you would be involved in the study will depend on how you respond to the treatment and what the doctors recommend, but it involves ongoing treatment and monitoring.

Potential risks and benefits

Participating in this study might offer you access to a new treatment combination that could help shrink your cancer or slow its growth, potentially improving your quality of life. However, like all medicines, the drugs used in this study can have side effects, which might range from mild to more serious. The study team will carefully monitor you for any side effects and support you throughout. It's important to always discuss any concerns with your doctor. You have the right to leave the study at any time, for any reason, without it affecting your usual 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
Italy

Common questions

What does 'locally recurrent' mean?

It means the cancer has come back in the same area, in this case, the chest wall, after previous treatment.

What is 'inoperable' cancer?

This refers to cancer that cannot be removed safely by surgery, often because of its size, location, or spread.

Are the drugs in this study new?

No, pembrolizumab (Keytruda) and cyclophosphamide (Endoxan) are both existing cancer drugs; this study is testing them in a new combination.

What is a 'Phase II' study?

It's a stage of research where doctors test a new treatment on a smaller group of people to see if it's effective and to check for side effects.

What is the main goal of this study?

The main goal is to find out how many patients respond to the combined treatment, meaning their tumors shrink or disappear.