Active not recruitingPHASE2INTERVENTIONAL

Study of the Impact of DPD Activity on the Efficacy of Capecitabine

This research study is for women with advanced breast cancer. It's looking into how a natural process in the body, called DPD activity, affects a chemotherapy drug named capecitabine. Before starting capecitabine, your DPD activity will be checked. This is important because DPD plays a role in how your body handles the drug. Researchers will then follow your progress for up to two years to see if your DPD level influences how well the capecitabine works for you. The main goal is to understand if checking DPD activity can help us better predict how effective capecitabine might be for individual patients.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Centre Antoine Lacassagne

Enrolment target

155

Start

20 Jul 2020

Estimated completion

01 Jul 2030

Breast Neoplasm Malignant Female

What is this study about?

This study is investigating a chemotherapy drug called capecitabine, which is used to treat advanced breast cancer. Specifically, it's looking into something called DPD activity. DPD is a natural process in your body that helps break down certain substances, including capecitabine. The idea behind this study is to see if measuring your DPD activity before you start treatment with capecitabine can help doctors understand how well the drug might work for you.

For patients with advanced breast cancer, finding the most effective treatment with the fewest side effects is very important. By understanding if DPD activity influences how capecitabine works, doctors might one day be able to personalise treatment plans better. This could mean fewer wasted treatments and better outcomes for patients.

The study will follow participants closely for up to two years after they start capecitabine. Researchers will compare DPD activity levels with how well the treatment works and any side effects experienced. This information will help build a clearer picture of the link between DPD activity and the effectiveness of capecitabine.

Key takeaways

Looks at how specific body process (DPD) affects breast cancer drug (capecitabine).
Aims to understand if DPD levels can predict treatment success.
For women with advanced HER2 negative breast cancer.
Participation involves DPD test and follow-up during capecitabine treatment.
Could help doctors personalise future breast cancer treatments.

Who may be eligible?

This study is specifically designed for women aged 18 or older who have advanced breast cancer that is HER2 negative.

You would be considered for this study if your doctors believe capecitabine on its own is a suitable treatment for you at a specific dose. You'd also need to have measurable cancer that can be tracked, either by scans or photographs if it's on the skin. You must also have social welfare coverage.

However, you wouldn't be able to join if you have certain existing health conditions, such as uncontrolled brain metastases, or if you've had other cancers recently that aren't fully cleared up. Your general health and ability to carry out daily activities will also be considered to make sure you can safely participate.

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 over 18 years old?
Do you have advanced breast cancer that is HER2 negative?
Has your doctor agreed that capecitabine on its own is a good treatment for you?
Do you have cancer that can be measured or seen on scans?
Do you have social welfare coverage?

Answer every question to see your result.

What does participation involve?

If you join this study, your DPD activity will be checked before you start your capecitabine treatment. You will then receive capecitabine as prescribed by your doctor, which involves taking it for 14 days, then having a 7-day break, repeated every 21 days.

You will have regular check-ups and assessments throughout your treatment to monitor how you're doing and how the cancer is responding. These will include standard check-ups and scans that you would typically have as part of your cancer care. The research team will follow your progress with capecitabine for up to 24 months, or until your treatment changes.

Potential risks and benefits

Participating in this study might help researchers understand more about how capecitabine works for different people, which could benefit future patients. There's no guarantee it will directly benefit you, but you will receive standard capecitabine treatment. Potential risks are generally those associated with capecitabine itself, such as side effects, though the DPD assessment is a straightforward test. You are always free to leave the study at any time, for any reason, without affecting your regular medical care.

Locations (5)

Clinique Saint Jean
Verified postcode
Cagnes-sur-Mer, France
Centre Azuréen de Cancérologie
Verified postcode
Mougins, France
Clinique St Georges
Verified postcode
Nice, France
Centre Antoine Lacassagne
Verified postcode
Nice, France
Hôpital Princesse Grâce
Verified postcode
Monaco, Monaco

Common questions

What is DPD activity?

DPD activity is a natural process in your body that helps break down certain substances, including the chemotherapy drug capecitabine.

What is capecitabine?

Capecitabine is a chemotherapy drug used to treat advanced breast cancer. It's often taken as tablets.

Will this study change my cancer treatment?

No, you will receive capecitabine treatment as decided by your doctor. The study is about observing how your body reacts to it.

How long will I be in the study?

You'll be followed for up to 24 months, or until your capecitabine treatment changes.

Will I have extra tests?

The main extra test is the DPD activity assessment before treatment. Other assessments are usually part of your standard cancer care.