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T-DXd Combinations for Breast Cancer (DB-08 Trial)
DB-08 Trial Summary
This trial will study the safety and effectiveness of a new drug combination in people with metastatic HER2-low breast cancer.
DB-08 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowDB-08 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.DB-08 Trial Design
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Who is running the clinical trial?
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- I have or had lung inflammation treated with steroids, or it can't be ruled out by scans.I have been treated with a specific drug that targets cancer cells.I do not have any uncontrolled illnesses.You have a current, ongoing immune system disorder.I have HR- breast cancer and have had specific prior treatments depending on the study part.If you have hormone receptor-positive breast cancer, for Part 1, you must have had at least one treatment with hormonal therapy, with or without a targeted therapy, and at least one treatment with chemotherapy for metastatic breast cancer. For Part 2, you can have only one prior treatment with hormonal therapy, with or without a targeted therapy, and no prior chemotherapy in the metastatic setting.My cancer has spread to my brain or spinal cord.I am 18 years old or older.I have serious lung-related health issues.I am fully active or can carry out light work.My breast cancer is HER2-low, hormone receptor positive, and not responsive to estrogen or progesterone.I do not have an infection needing IV drugs.I have serious heart problems that are not under control.You need to have enough tumor sample for testing.
- Group 1: Module 2: T-DXd + durvalumab + paclitaxel
- Group 2: Module 3: T-DXd + capivasertib
- Group 3: Module 5: T-DXd + fulvestrant
- Group 4: Module 1: T-DXd + capecitabine
- Group 5: Module 4: T-DXd + anastrozole
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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 what extent can Fulvestrant be considered a health risk for those taking it?
"The evaluation of Fulvestrant's safety on a scale from 1-3 yielded an overall score of 1 due to the limited amount of data available regarding its efficacy and security."
What is the current geographic distribution of this experiment?
"The presented medical trial is enrolling participants at 17 sites, including Commack, Chattanooga and Basking Ridge as well as other cities. To lessen travel time, it would be best to select the most proximate location for you if any involvement in this study transpires."
How many volunteers have enrolled in this experiment?
"Affirmative. According to the clinicaltrials.gov page, registration for this medical trial began on December 17th 2020 and concluded October 31st 2022. 182 individuals are sought out from a total of 17 enrolment sites."
Is this clinical research program currently enrolling participants?
"Affirmative. According to the information posted on clinicaltrials.gov, recruitment for this trial is still ongoing; it was initially published in December 17th 2020 and its details were last updated on October 31st 2022. A total of 182 participants must be enrolled from a pool of 17 designated sites."
Is there precedent for using Fulvestrant as part of a medical investigation?
"Fulvestrant, initially studied in 1997 by the City of Hope Comprehensive Cancer Center, has seen 1958 studies come to completion. Presently 1596 clinical trials are active, many based out of Commack, New york."
What are the research objectives of this investigation?
"The main objective of this two-year study is to evaluate the occurrence of adverse events associated with durvalumab administration. Secondary endpoints are progression free survival, overall survival, and serum concentration levels of durvalumab over time."
For what ailments is Fulvestrant typically prescribed?
"Fulvestrant is most commonly deployed to treat non-small cell lung cancer. Additionally, it can be beneficial in treating metastatic bladder cancer, acquired immunodeficiency syndrome, and advanced thymoma cases."
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