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An advanced breast clinical trial - IND241A

Monitoring advanced breast cancer patients on standard treatment
Disease Site
Investigational New Drug Program
Trial Code
IND.241A | NCT05601440
Trial Status

What is the purpose of this study?

The purpose of this study is to follow (monitor) your disease, by testing tumour tissue and blood samples to learn more about your cancer and how it responds while you are receiving standard of care treatment with a CDK inhibitor with endocrine therapy.

Why is this study important?

This study may help researchers better understand how breast cancers being treated with standard of care CDK inhibitor and endocrine therapy may or may not respond to treatment, and whether some cancers with specific biomarkers may respond better.

Who can participate in this study?

This trial is for people:

  • with ER positive, HER2 negative, advanced breast cancer
  • on or about to start a CDK inhibitor with endocrine therapy

This trial is not for people:

  • who are being currently treated for another cancer
  • with active or uncontrolled infections or serious illnesses/medical conditions
  • who are pregnant or breastfeeding

You will find complete details of who this trial is for by visiting https://clinicaltrials.gov/study/NCT05601440

What are the risks?
  • If you choose to take part in this study, there will be more blood taken than the amount of blood taken during usual care. The most common risks related to drawing blood from your arm are brief pain and maybe a bruise.
  • This study will use a sample of your tissue. Generally, your hospital will keep some of your tissue. This archived tissue may be used to help treat your cancer in the future. Because this study will need to use some of this tissue, there is a small risk that it could be used up.
  • You will find details of all side effects and risks in the Consent document.
What can I expect?
  • If you choose to take part in this study, you will be followed (monitored) during your treatment until your disease worsens and your treatment with CDK inhibitor and endocrine therapy stops.
  • During this monitoring period, your blood will be taken periodically to test for biomarkers, along with the usual follow up care (including imaging such as scans) by your hospital.

How can I find out more or join the study?

Talk to your cancer doctor if you are considering joining this study. You can share summaries like this with them and ask if they think joining the trial may be a good option for you.

Before you join this study, you will be asked to review an Informed Consent document which will tell you more about why the research is being done and your role as a participant. You will have an opportunity to discuss anything that is not clear and ask any questions you have.

Joining this study is entirely up to you and you can decide to leave at any time without giving a reason. Your decision to join or leave the trial will not affect your standard medical care.

The IND.241A study is currently enrolling patients at cancer centres in Canada. For a full list of participating cancer centres please visit https://clinicaltrials.gov/study/NCT05601440

Use this trial information for your conversation with your health care team

Participating centres

Information coming soon.