Your session is about to expire
← Back to Search
T-DXd for HER2 Positive Breast Cancer (DESTINY-B12 Trial)
DESTINY-B12 Trial Summary
This trial is testing a new drug for people with HER2-positive breast cancer that has progressed after other treatments. The drug will be given to people with or without brain metastases.
DESTINY-B12 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowDESTINY-B12 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.DESTINY-B12 Trial Design
Find a Location
Who is running the clinical trial?
Media Library
- If you have hepatitis C, you can join the study only if a specific test shows that the virus is not active in your body.You had a heart attack or have significant heart failure symptoms within the past 6 months.You have had breast cancer treatment that did not work, and you have tried no more than 2 different treatments for cancer that has spread.You should not have untreated brain lesions larger than 2.0 cm, be using systemic corticosteroids for brain lesion symptoms, or have uncontrolled seizures or worsening neurological symptoms due to brain lesions.You cannot have signs of brain metastases, or if you do, they must not need immediate treatment or must have been treated and are not getting worse.You have at least one lesion that can be measured accurately and is at least 10 mm in diameter, or you have non-measurable bone disease that can be assessed by imaging. If you have only sclerotic/osteoblastic bone lesions without measurable disease, you are not eligible. If you have non-measurable central nervous system (CNS) disease, you may be eligible for a specific part of the study.Your organs and bone marrow need to be working well within 14 days before starting the treatment.You have a known or suspected disease affecting the covering of the brain and spinal cord.You have already taken tucatinib before.You have ongoing severe nausea and vomiting, long-term stomach or bowel problems, or a history of major bowel surgery that might affect how your body processes T-DXd.You had a different type of cancer, but it was treated completely and has not come back for at least 3 years.You have spinal cord compression.You have an infection that is not being controlled by regular antibiotics, antiviral or antifungal medications.You are allergic to the study treatment or any of its ingredients.You have a current hepatitis B or C infection. If you had hepatitis B in the past but don't have it now, you may be able to participate if certain tests are negative and positive.You have had radiation treatment to a certain area of your body within a specific time frame before starting the study.You are in good enough health to carry out daily activities without limitations (Eastern Cooperative Oncology Group performance status 0-1).You got a live vaccine within 30 days before starting the T-DXd treatment.You still have side effects from your previous cancer treatment that have not gotten better.You have serious ongoing health issues related to your lungs, or autoimmune, connective tissue, or inflammatory disorders.You have taken chloroquine or hydroxychloroquine within the last 14 days without enough time for it to leave your body before starting the study.You have not received certain types of cancer treatments within a specific time period before starting the trial.If you have brain metastases, you must be neurologically stable.Your heart's pumping function is normal, with a measurement of 50% or higher within the last 28 days.Women who could become pregnant must have a negative pregnancy test.You have had lung problems in the past that needed steroids, currently have lung problems, or might have lung problems that can't be ruled out by imaging tests.You have been diagnosed with advanced or metastatic breast cancer and have been confirmed to have HER2-positive cancer.
- Group 1: Trastuzumab Deruxtecan
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there any available positions left in this research project?
"Yes, the trial is currently recruiting patients. It was originally posted on 6/22/2021 and was last edited on 10/19/20222. They are looking for 500 participants from 7 different sites."
How many test subjects are a part of this investigation?
"That is correct, the online information indicates that this study is still recruiting patients. The initial posting was on 6/22/2021 and there have been updates as recently as 10/19/2022. They are looking for 500 individuals total from 7 different locations."
Are there any restrictions on who is able to enroll in this clinical trial?
"This trial is looking for 500 patients that have breast cancer and are aged 18-130. Applicants will be required to meet the following criteria: ≥ 7 days since stereotactic radiosurgery or gamma knife, ≥ 21 days since whole brain radiotherapy, Eastern Cooperative Oncology Group performance status 0-1, Previous breast cancer treatment: radiologic or objective evidence of disease progression on or after HER2 targeted therapies and no more than 2 lines/regimens of therapy in the metastatic setting, Participant with the following measurable: at least 1 lesion that can be accurately measured at baseline as ≥ 10 mm in the longest diameter with"
What other scientific papers exist on Trastuzumab Deruxtecan's efficacy?
"Trastuzumab Deruxtecan was first trialled in 2015. In the 5 years since, there have been 37 completed studies with many more currently underway - particularly in Boston, Massachusetts."
Is this a new clinical trial?
"There are 37 clinical trials for Trastuzumab Deruxtecan that are ongoing across 487 cities and 44 countries. The earliest study was conducted in 2015 by Daiichi Sankyo, Inc. This trial completed its Phase 1 drug approval stage with 292 patients. 5 other trials have been conducted since then."
Are there any dangers associated with Trastuzumab Deruxtecan?
"Trastuzumab Deruxtecan is considered to be a safe medication, as it has received a score of 3. This is due to the fact that this drug is currently in Phase 3 clinical trials, which suggests that not only is there some evidence pointing to its efficacy, but also that multiple rounds of tests have yielded positive results in regards to safety."
Is this trial taking place in numerous hospitals across America?
"To limit participant burden, the team conducting this study chose to set up shop in 7 locations. These sites are situated in Boston, Detroit, San Diego and 4 other cities."
What are the objectives of this experiment?
"This clinical trial will focus on Progression-free Survival (PFS) in participants with brain metastases (BM) at baseline. The study's secondary outcomes include the number of participants with Investigator-assessed ILD/Pneumonitis or Rate of Investigator-assessed ILD/Pneumonitis, Time to new CNS Lesions in Participants with BM at Baseline, and Duration of Response (DoR)."
Does this experiment allow octogenarians to participate?
"This specific clinical trial is open to patients aged 18-130. In total, there are 3400 trials for seniors and 178 for minors currently taking place."
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger