A study interested in understanding the mechanisms of resistance to antibreast cancer therapies

1. Why is the REMERGE clinical trial needed?

REMERGE is a scientific research study that does not use any treatment or new drug. The purpose of this study is to assess and understand the changes that happen to breast cancer over time, with the intention to improve breast cancer therapies or develop new therapies in the future. The data from this trial will help to better understand the biology of breast cancer, which may explain the reasons for the uncontrolled growth of the cancer cells and why these are not responding well to some treatments.

2. How does the REMERGE clinical trial work?

The REMERGE study is designed for participants diagnosed with breast cancer who are being treated with an anti-cancer therapy.

Breast cancer patients will be asked to provide consent to donate tumor tissue and blood samples for testing if their disease starts to worsen. This study requires the participant to attend the clinic for one visit in person to collect samples of their tumor tissue and a small volume of blood. Total time of participation in the clinical trial will be about 3-4 weeks including time for follow up.

3. What are the main endpoints of the REMERGE clinical trial?

The main clinical trial endpoint (the main results measured in the trial) is to find out how tumors change during treatment for breast cancer in order to understand why anti-cancer therapies stop working.

The other clinical trial endpoints include to find out why some tumors do not respond to anti-cancer therapies, to compare findings in tumor tissue and blood, to better understand the disease and to support development of tests or tools that help with detecting or understanding the disease.

4. Who can take part in this clinical trial?

Participants can take part in this trial if they have breast cancer, if they received anti-cancer therapy and the disease starts to worsen, and if they provide consent to donate their tissue and blood samples.

Participants may not be able to take part in this trial if there are any risks of complications associated with the procedures to obtain the samples, if they discontinued the anti-cancer therapy for other reasons than their disease worsening or if they already started a new anti-cancer therapy.

5. What treatment will participants be given in this clinical trial?

Participants will not receive treatment within this clinical trial but will receive the therapies as per local regulations and guidelines.

6. Are there any risks or benefits in taking part in this clinical trial?

People who would like to participate will be told about any risks and benefits of taking part in the clinical trial, as well as any additional procedures, tests, or assessments they will be asked to undergo. All of these will be described in an informed consent document (a document that provides people with the information they need to decide to volunteer for the clinical trial).

Participants may have side effects (an unwanted effect of a procedure) from the procedures for collecting the samples obtained in this clinical trial. Participants will be monitored after the procedures during the clinical trial for safety assessments.

Potential benefits associated with the clinical trial

There are no direct benefits from donating the samples. However, research performed on these samples may help other people with similar medical conditions in the future.