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Dato-DXd for Breast Cancer (TB-01 Trial)
TB-01 Trial Summary
This trial will compare the safety and effectiveness of Dato-DXd with standard chemotherapy for people with inoperable or metastatic breast cancer that is HR-positive and HER2-negative.
TB-01 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTB-01 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.TB-01 Trial Design
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Who is running the clinical trial?
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- I can care for myself and have not gotten worse in the past 2 weeks.I do not have serious heart problems or very high blood pressure.I had cancer before, but it was treated over 3 years ago and is not likely to come back.My blood, liver, kidney, and heart functions meet the trial's requirements.I do not have active or uncontrolled hepatitis B or C.I have a tumor that can be measured and hasn't been treated with radiation.My cancer has worsened despite hormone therapy and I've had 1-2 chemotherapy treatments.Criterion: You have a history of heart rhythm problems, lung inflammation, lung problems, severe lung diseases, brain and spinal cord cancer spread, serious eye problems, or active tuberculosis.You have received certain cancer treatments, are currently receiving other cancer treatments (except for specific bone treatments), or have had major surgery or significant injury recently. You have also received a live, weakened vaccine in the past month.I do not have an ongoing infection needing IV treatment.I've had 1-2 chemotherapy treatments for my inoperable/metastatic cancer and it's still progressing.I had spinal cord compression or inactive brain tumors treated, don't need steroids or seizure meds, and it's been 2 weeks since my last radiation therapy.I had spinal cord compression or inactive brain tumors treated, don't need steroids or seizure meds, and it's been 2 weeks since my last radiation therapy.My breast cancer cannot be removed by surgery and is HR+ and HER2-.I am 18 years old or older.My condition matches the study's required disease characteristics.I am eligible for specific chemotherapy treatments as decided by my doctor.My physical ability hasn't worsened in the last 2 weeks and I can care for myself.I am 18 years old or older.I have long-term side effects from cancer treatment, but they are stable and not severe.I am eligible for chemotherapy with eribulin, capecitabine, vinorelbine, or gemcitabine.I am using birth control approved by this study's guidelines, not including oral estrogens.My HIV infection is not well controlled.
- Group 1: Dato-DXd
- Group 2: Investigators Choice of Chemotherapy (ICC)
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
What is the government's official stance on Dato-DXd?
"Dato-DXd's safety is not in question and it thus received a score of 3."
How many research centers are conducting this experiment?
"If you are interesting in taking part of this trial, know that it is currently being conducted at 25 different centres. These locations include cities such as Palo Alto, Commack and Los Angeles. It would be ideal to select a location nearest to you to reduce the hassle of travel."
For what medical conditions is Dato-DXd commonly prescribed?
"Dato-DXd is an effective treatment for patients that have undergone adjuvant anthracycline-containing therapy, as well as those with soft tissue sarcoma and colorectal carcinoma."
What goals does this research aim to achieve?
"According to the study sponsor, AstraZeneca, the primary outcome of this clinical trial will be Overall Survival, which will be measured over a period of 21 months. Additionally, the trial will assess secondary outcomes including Disease Control Rate (DCR), Objective Response Rate (ORR), and Immunogenicity."
Are new participants still being recruited for this experiment?
"That is correct. The clinical trial in question, which was first posted on October 18th 2021, appears to be actively recruiting participants according to the data available on clinicaltrials.gov. This particular study is looking for 700 patients across 25 different sites."
What other investigations have included Dato-DXd in their analysis?
"There are 847 distinct clinical trials being conducted worldwide to study the efficacy of Dato-DXd. Out of those, 261 have reached Phase 3. Many of these studies take place in Guangzhou, Guangdong; however, there are a total of 37085 different locations running Dato-DXd trials."
How many test subjects are required for this clinical trial?
"That is accurate. The online clinicaltrials.gov registry shows that this trial, which was first advertised on October 18th 2021, is looking for 700 more participants across 25 sites."
Who else is applying?
What state do they live in?
How old are they?
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What portion of applicants met pre-screening criteria?
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