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T-DXd vs T-DM1 for HER2-Positive Breast Cancer
Study Summary
This trial will compare the effectiveness of two different drugs in treating HER2-positive breast cancer that has spread and is resistant to other treatments.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have or had lung inflammation that needed steroids, or it might be seen in my recent lung scans.I have untreated, symptomatic brain or spinal cord metastases requiring medication.My kidney and liver are functioning well.I am legally considered an adult in my country.My cancer is confirmed HER2-positive by specific guidelines.My breast cancer cannot be surgically removed or has spread.I have been treated with an anti-HER2 drug for cancer that has spread.I have serious heart problems that are not under control.My most recent tumor sample is HER2 positive, or I agree to a new biopsy if needed.I was treated with trastuzumab and taxane for advanced cancer or it worsened within 6 months after similar treatment.My cancer has grown or spread on scans after my last treatment.I agree to use effective birth control or avoid sex for 7 months (females) or 4.5 months (males) after my last treatment dose.My brain metastases have been treated, I'm not on steroids or seizure meds, and it's been 2 weeks since my last brain radiation.My brain metastases are not currently causing symptoms.
- Group 1: Trastuzumab deruxtecan (T-DXd)
- Group 2: Ado-trastuzumab emtansine (T-DM1)
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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
To your knowledge, is this a groundbreaking trial?
"Trastuzumab deruxtecan (DS-8201a) was first studied in 2008 by Hoffmann-La Roche. The initial trial involved 720 patients and, after its success, the drug received Phase 2 approval. Presently, 78 trials are ongoing across 1575 cities and 59 countries."
Is this trial widely available in urban areas?
"The 31 sites conducting this research are situated in various cities, including but not limited to Cincinnati, Toronto and Houston. To limit travel demands, it is best to select a location near you when enrolling for the study."
Is this research project still recruiting participants?
"As of 4/1/2022, this trial is no longer recruiting patients. This study was first posted on 8/9/2018. If you are looking for other studies, 2695 trials for breast cancer and 78 trials for Trastuzumab deruxtecan (DS-8201a) are currently active and recruiting patients."
Are there any other ongoing research projects that are similar to this one?
"Trastuzumab deruxtecan (DS-8201a) is being researched in 78 different studies, 17 of which are Phase 3 trials. The majority of these studies are based out of Phoenix, Arizona; however, there are 8717 total locations running trials for this medication."
What are the expected outcomes of this experiment?
"The purpose of this study is to see if the progression-free survival rate improves in participants with HER2-positive, metastatic breast cancer who have been previously treated with trastuzumab and taxane. The study will last for 43 months and progress will be monitored through blinded independent central review (BICR). Additionally, researchers will look at objective response rate (ORR), duration of response (DoR), and progression-free survival (PFS) based on investigator assessment."
How many guinea pigs are being used in this test?
"Unfortunately, this particular trial has stopped searching for new participants. However, if you are still interested in clinical trials related to breast cancer or Trastuzumab deruxtecan (DS-8201a), there are 2695 and 78 studies respectively that remain open."
What is Trastuzumab deruxtecan (DS-8201a) used to target?
"Trastuzumab deruxtecan (DS-8201a) is an effective treatment for patients with breast, non-small cell lung carcinoma, and metastatic her2-positive breast cancer who have received two or more prior anti-her2-based regimens in the metastatic setting."
Is Trastuzumab deruxtecan (DS-8201a) a dangerous cancer drug?
"There is some efficacy data and multiple rounds of safety data from Phase 3 trials, so Trastuzumab deruxtecan (DS-8201a) received a score of 3 for safety."
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