All studies
Active not recruitingPHASE3INTERVENTIONAL

Detect V / CHEVENDO (Chemo vs. Endo)

This study, called DETECT V / CHEVENDO, is for women aged 18 and over with metastatic breast cancer that is both HER2-positive and hormone-receptor positive. This means the cancer cells have certain features that can be targeted by specific medicines. The study is comparing two main treatment approaches. Both approaches use two targeted drugs, Herceptin and Perjeta, plus another drug called Kisqali. One group will also receive hormone therapy, and the other group will receive chemotherapy. The goal is to find out which combination is safer and more effective at controlling the cancer, while also helping patients maintain a good quality of life. This is a Phase 3 study, which means it's testing potential new standard treatments.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
Prof. Wolfgang Janni
Enrolment target
271
Start
01 Sep 2015
Estimated completion
31 Jan 2025

What is this study about?

When breast cancer spreads to other parts of the body, it's called metastatic breast cancer. While it can't always be cured, treatments aim to slow its growth and help people live well. Chemotherapy is a common treatment, but it can have difficult side effects that impact everyday life. This study is looking into different ways to treat metastatic breast cancer that has two specific features: it's 'HER2-positive' and 'hormone-receptor positive'. These features mean the cancer cells respond to certain types of targeted medicines.

The DETECT V / CHEVENDO study wants to find out if a treatment combination that uses targeted drugs and hormone therapy is better than a combination of targeted drugs and chemotherapy. All participants in the study will receive two targeted drugs, Herceptin and Perjeta, which specifically attack HER2-positive cancer cells. They will also receive a drug called Kisqali, which works in another way to slow cancer growth. Then, half the participants will get hormone therapy (which blocks the hormones that can make cancer grow), and the other half will get chemotherapy.

The main idea behind this study is to see if we can control the cancer effectively while causing fewer side effects. Hormone therapy often has less severe side effects than chemotherapy, so finding an effective combination that includes it could greatly improve a patient's quality of life. This research is important because it could lead to new, gentler, yet powerful treatment options for people with this type of advanced breast cancer.

Key takeaways

  • Compares chemotherapy with hormone therapy, both combined with targeted drugs.
  • For advanced (metastatic) breast cancer that is HER2-positive and hormone-receptor positive.
  • Aims to find effective treatment with fewer side effects.
  • Could help maintain quality of life.
  • Participants will receive standard targeted drugs plus either chemo or hormone therapy.
  • This is a Phase 3 study, testing potential new standard treatments.

Who may be eligible?

This study is looking for women aged 18 or older who have metastatic breast cancer that has spread. To be considered, your cancer needs to have two specific features: it must be HER2-positive and hormone-receptor positive. These features will have been confirmed by tests on your tumour.

You should have good overall health and organ function. This means your heart, liver, and blood counts should be within certain healthy ranges. You also cannot have had too many previous chemotherapy or HER2-targeted treatments for your metastatic cancer. If you've had a specific HER2 drug called pertuzumab before, it must have been at least 12 months ago.

Your doctors will need to be able to measure your cancer on scans to see how it responds to treatment. You will also need to be able to sign a consent form, showing you understand the study and agree to take part.

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.

  1. Are you 18 years old or older and female?
  2. Has your breast cancer spread to other parts of your body?
  3. Have tests shown your cancer is both HER2-positive and hormone-receptor positive?
  4. Have you had fewer than two previous chemotherapies for your metastatic cancer?
  5. Are your heart, liver, and blood tests generally stable?
  6. Are your doctors able to measure your cancer on scans?
Answer every question to see your result.

What does participation involve?

If you join this study, you will receive one of the two treatment combinations described. You will have regular appointments for check-ups, blood tests, and scans to monitor your health and how the treatment is working. Doctors will also track any side effects you might experience. The exact number of visits and the total duration in the study will vary depending on your treatment and how you respond, but will involve ongoing monitoring as long as the treatment is beneficial and you tolerate it.

Potential risks and benefits

Participating in a clinical trial may offer potential benefits, such as access to new treatments before they are widely available, and close medical monitoring. However, there are also potential risks, including side effects from the study drugs, which can vary in severity. It's important to remember that treatments might not work for everyone. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

  • University Hospital Ulm Gynecology/Obstetrics
    Verified postcode
    Ulm, Germany

Common questions

What does 'metastatic breast cancer' mean?

Metastatic breast cancer means the cancer has spread from the breast to other parts of the body.

What does 'HER2-positive and hormone-receptor positive' mean?

These are features of the cancer cells that show they might respond to specific types of targeted medicines and hormone therapies.

What is the difference between targeted therapy and chemotherapy?

Targeted therapies are designed to attack specific features of cancer cells, often with fewer side effects. Chemotherapy uses strong drugs to kill fast-growing cells, including cancer cells, but can also affect healthy cells.

Will I know which treatment I'm getting?

This is a 'randomised' study, meaning you will be assigned to one of the treatment groups by chance. Your doctor will discuss the details with you.

Can I stop the study treatment if I want to?

Yes, you can choose to leave the study at any time, for any reason, without it affecting your regular medical care.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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