NCT# stands for National Clinical Trial number. This is a unique identification code given to each clinical trial registered on ClinicalTrials.gov. The format is "NCT" followed by an 8-digit number (for example, NCT00000419). Also called the ClinicalTrials.gov identifier.
With your help, we can work toward creating better breast cancer treatment options.
The goal of the DV-006 clinical trial is to help us learn if the study medicine may treat different kinds of HER2-expressing advanced breast cancers by targeting cells that make HER2.
Thank you for taking the time to learn more.
This clinical trial may be an option for you if you have locally advanced, unresectable, or metastatic HER2-expressing breast cancer that has worsened after prior treatments.
HER2 is a type of protein that helps cells grow. It can cause tumor growth when tumor cells make the HER2 protein. Breast cancers that make HER2, called HER2-expressing cancers, are grouped into categories based on how much HER2 the cells make:
Other criteria may apply, which your clinical study team will discuss with you.
Condition
HER2-expressing, locally advanced, unresectable, or metastatic breast cancer
Age
18+ years
Sex
Male or Female
Each clinical study has its own guidelines for who can participate, called eligibility criteria. However, only your clinical study team can determine if you qualify to enroll in the study.
If you choose to participate, you will sign informed consent documents and continue with the screening period. During the screening period, tests (such as a physical exam, tumor imaging, and blood sample collections) will be performed to confirm whether you meet all eligibility criteria.
If you qualify for this clinical trial and choose to participate, you will be assigned to a study group based on how much HER2 your cancer makes and if your cancer is hormone receptor (HR) positive or negative:
You will continue to receive the study medicine until imaging scans show that your cancer is getting worse, the study doctor thinks you are no longer benefiting from the study medicine, you have side effects that become too severe, or you choose to stop taking the study medicine.
An experienced team of healthcare providers will regularly monitor your health and tumor growth throughout the study.
Length of study treatment
Depends on how your cancer responds, how well you tolerate the study medicine, and your personal choice
Number of study visits
About 2x per month while you are receiving the study medicine
Long-term follow up
Your clinical study team will continue to monitor your health and disease status over time until the study is complete, which may last several years, or until you withdraw your consent to be contacted
The study medicine used in this clinical trial is disitamab vedotin (DV), an antibody-drug conjugate (ADC). It is thought to work by sticking to and killing cancer cells that make HER2.
Many factors, including genetics, race, and ethnicity, can impact how people respond to a medicine. That is why it is so important that clinical trials include people of all backgrounds. The greater the diversity among clinical trial participants, the more we can learn about potential medicines, including how they work for different people.
When you participate in a clinical trial, you’re paving the way for both the community you represent, and all people affected by breast cancer.
Yes. All participants will receive active study medicine. There is no placebo in this clinical trial.
Every participant will receive the study medicine, disitamab vedotin (DV). It will be given to you by an intravenous (IV) infusion every two weeks.
You will continue to receive the study medicine until imaging scans show that your cancer is getting worse, the study doctor thinks you are no longer benefiting from the study medicine, you have side effects that become too severe, or you choose to stop taking the study medicine.
Most study visits will last a couple of hours, though some visits may last longer, depending on required assessments. Your study doctor will let you know exactly how long you will need to stay for each visit.
You will need to attend most study visits in person. This is because the evaluations that are part of this clinical trial need to be done in person. If you can’t make a scheduled visit, you should contact your clinical study team as soon as possible to reschedule. Some visits in the follow-up period (once you stop receiving the clinical trial treatment) may be conducted via telephone.
If, for any reason, you are asked to stop taking the study medicine, or you want to stop taking the study medicine, end-of-treatment procedures will be performed as soon as possible after your last dose of the study medicine. Then, you will continue with the follow-up period of the clinical trial. During the follow-up period, your clinical study team will continue to monitor your health and disease status over time until the study is complete, which may last several years, or until you withdraw your consent to be contacted.
It may be possible for you to continue taking disitamab vedotin after the clinical trial is over. Your doctor will decide if you would benefit from this. The length of time you would continue to take disitamab vedotin will be limited and may end before disitamab vedotin is available where you live.
You are always free to leave a clinical trial at any time and for any reason, without penalty to you. If you decide to leave the clinical trial, please tell the study doctor so that you can end participation in the safest way. The study doctor will explain what other steps may occur.
Your decision to stop being in the clinical trial will not affect your regular medical care or any benefits to which you are entitled.
Your privacy and confidentiality are our priority while participating in our clinical trials. Your personal information will be protected in compliance with relevant laws and in the manner explained in the informed consent document.
