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Monoclonal Antibodies
Trastuzumab Deruxtecan for Metastatic Breast Cancer
Phase 3
Waitlist Available
Research Sponsored by Daiichi Sankyo
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Has low-HER2 expression defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested)
Has adequate archival tumor samples available or is willing to provide fresh biopsies prior to randomization for assessment of HER2 status and post-treatment status
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from screening and every 6 weeks up to withdrawal of subject consent, progressive disease (pd), or unacceptable toxicity, up to approximately 3 years
Awards & highlights
Study Summary
This trial will compare DS-8201a to the standard treatment for HER2-low breast cancer that has spread.
Who is the study for?
This trial is for adults with HER2-low breast cancer that's inoperable or has spread, and who have tried endocrine therapy without success. They should have had 1-2 prior chemotherapy treatments in the metastatic setting, be able to provide tumor samples, and not have high-HER2 cancer or a history of certain lung conditions.Check my eligibility
What is being tested?
The study compares DS-8201a (Trastuzumab Deruxtecan) with standard treatments chosen by physicians such as Eribulin, Paclitaxel, Gemcitabine, Capecitabine or Nab-paclitaxel. Participants will receive either the new drug or one of these existing drugs based on their doctor's choice.See study design
What are the potential side effects?
Possible side effects include allergic reactions to medication components, fatigue, nausea and vomiting from chemotherapy drugs. Trastuzumab Deruxtecan may cause issues like hair loss and low blood cell counts leading to increased infection risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has low levels of HER2.
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I can provide samples of my tumor for testing before treatment starts.
Select...
My cancer has grown or spread on my latest scans.
Select...
My breast cancer cannot be surgically removed or has spread.
Select...
I am legally considered an adult in my country.
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My condition worsened despite hormone therapy.
Select...
My heart, liver, kidneys, bone marrow, and blood clotting functions are all within normal ranges.
Select...
My cancer was never previously tested positive for HER2.
Select...
I've had 1-2 rounds of chemotherapy for my cancer after it came back or spread.
Select...
My cancer is either hormone receptor positive or negative.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from screening and every 6 weeks up to withdrawal of subject consent, progressive disease (pd), or unacceptable toxicity, up to approximately 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from screening and every 6 weeks up to withdrawal of subject consent, progressive disease (pd), or unacceptable toxicity, up to approximately 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-free Survival (PFS) Based on Blinded Independent Central Review (BICR) in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer
Secondary outcome measures
Best Overall Response and Confirmed Objective Response Rate (ORR) in Participants With HER2-low Breast Cancer (All Patients)
Best Overall Response and Confirmed Objective Response Rate (ORR) in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer
Duration of Response in Participants With HER2-low Breast Cancer (All Patients)
+7 moreOther outcome measures
All-Cause Mortality
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Trastuzumab deruxtecanExperimental Treatment1 Intervention
HER2-low, unresectable, and/or metastatic breast cancer participants previously treated with chemotherapy randomized to DS8201a
Group II: Physician's ChoiceActive Control5 Interventions
HER2-low, unresectable, and/or metastatic breast cancer participants previously treated with chemotherapy randomized to Physician's choice from the following options:
Capecitabine
Eribulin
Gemcitabine
Paclitaxel
Nab-paclitaxel
Find a Location
Who is running the clinical trial?
Daiichi Sankyo Co., Ltd.Industry Sponsor
115 Previous Clinical Trials
48,529 Total Patients Enrolled
3 Trials studying Breast Cancer
1,385 Patients Enrolled for Breast Cancer
Daiichi SankyoLead Sponsor
392 Previous Clinical Trials
410,808 Total Patients Enrolled
25 Trials studying Breast Cancer
17,070 Patients Enrolled for Breast Cancer
AstraZenecaIndustry Sponsor
4,262 Previous Clinical Trials
288,594,685 Total Patients Enrolled
173 Trials studying Breast Cancer
1,245,782 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been treated with a HER2-targeting therapy before.I can provide samples of my tumor for testing before treatment starts.I have spinal cord compression or active brain metastases.My cancer has grown or spread on my latest scans.My cancer has low levels of HER2.You have at least one detectable tumor according to specific medical guidelines.My breast cancer cannot be surgically removed or has spread.My breast cancer has high levels of HER2.I have serious heart problems that are not under control.I cannot receive any standard treatments my doctor would normally choose.I am legally considered an adult in my country.My condition worsened despite hormone therapy.My heart, liver, kidneys, bone marrow, and blood clotting functions are all within normal ranges.My cancer was never previously tested positive for HER2.I have or had lung inflammation that needed steroids, or it's suspected but not confirmed by scans.I've had 1-2 rounds of chemotherapy for my cancer after it came back or spread.My cancer is either hormone receptor positive or negative.
Research Study Groups:
This trial has the following groups:- Group 1: Trastuzumab deruxtecan
- Group 2: Physician's Choice
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What other implications has Trastuzumab deruxtecan (DS-8201a) had in research?
"DS-8201a, more commonly known as trastuzumab deruxtecan, was first studied in 1997. 2390 clinical trials have completed since then and 1497 are still ongoing. A large number of these active trials are taking place in Tampa, Florida."
Answered by AI
Would it be possible to join this experiment?
"This particular clinical trial is not enrolling patients at the moment. The listing was first posted on December 27th, 2018 and was edited most recently on January 25th, 2022. If you are looking for other studies, there are 2677 active studies recruiting breast cancer patients and 1497 active studies recruiting patients for Trastuzumab deruxtecan (DS-8201a)."
Answered by AI
In how many different hospitals is this medical study being conducted today?
"41 sites are running this study. Some notable locations are Tampa, Portland and Goodyear. To make the process as easy as possible for enrollees, it is best to choose a location close to them."
Answered by AI
What is the official government position on Trastuzumab deruxtecan (DS-8201a)?
"Trastuzumab deruxtecan (DS-8201a) has received a safety score of 3. This is because, as a Phase 3 trial, there is both efficacy and safety data available."
Answered by AI
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