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Monoclonal Antibodies
Trastuzumab Deruxtecan + Durvalumab for Breast Cancer (TRUDI Trial)
Phase 2
Recruiting
Research Sponsored by Filipa Lynce, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of study treatment with durvalumab and 4 months after the last dose of study treatment
Body weight >30 kg
Timeline
Screening 3 weeks
Treatment Varies
Follow Up disease assessed every 6 weeks by chest xray (+/- 1 week) until 8 cycles of neo-adjuvant therapy (one cycle=21 days); follow-up assessments post-surgery every 6 months (+/- 8 weeks) until participant withdrawal or death up to 4 years
Awards & highlights
TRUDI Trial Summary
This trial is testing a new drug combo to treat HER2-expressing inflammatory breast cancer.
Who is the study for?
This trial is for adults with stage III inflammatory breast cancer that expresses HER2, who haven't had prior treatment for this diagnosis. They must be in good health overall, have a life expectancy of at least 12 weeks, weigh over 30 kg, and agree to biopsies and contraception methods if applicable. Exclusions include previous severe reactions to the drugs being tested or similar medications, recent major surgeries or heart issues, active infections like TB or hepatitis B/C, HIV positivity, certain other medical conditions or treatments.Check my eligibility
What is being tested?
The TRUDI trial is testing the combination of two drugs: Trastuzumab deruxtecan and Durvalumab. It aims to determine their safety and effectiveness in treating HER2-positive inflammatory breast cancer. Participants will receive both medications as part of their treatment regimen.See study design
What are the potential side effects?
Potential side effects may include allergic reactions to medication components; fatigue; nausea; changes in blood counts leading to increased infection risk; potential heart problems such as reduced ejection fraction; lung issues like inflammation (pneumonitis); liver function changes; and diarrhea.
TRUDI Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I agree to use birth control during and for 4 months after my treatment.
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I weigh more than 30 kilograms.
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I understand the study requirements and agree to participate.
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I have not received any treatment for my condition.
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My organ and bone marrow functions are normal.
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I am fully active or able to carry out light work.
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I have been diagnosed with invasive breast cancer.
TRUDI Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ disease assessed every 6 weeks by chest xray (+/- 1 week) until completion of 8 cycles of neo-adjuvant therapy (one cycle=21 days); follow-up assessments post-surgery every 6 months (+/- 8 weeks) until participant withdrawal or death up to 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~disease assessed every 6 weeks by chest xray (+/- 1 week) until completion of 8 cycles of neo-adjuvant therapy (one cycle=21 days); follow-up assessments post-surgery every 6 months (+/- 8 weeks) until participant withdrawal or death up to 4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pathological complete response (pCR) Rate
Secondary outcome measures
Distant progression or distant disease-free survival (DP/DDFS)
Event Free Survival (EFS)
Residual Cancer Burden (RCB) Response
TRUDI Trial Design
2Treatment groups
Experimental Treatment
Group I: HER2-LowExperimental Treatment2 Interventions
Participants will be enrolled into one of two cohorts: HER2 positive IBC (cohort 1) and HER2 low IBC (cohort 2)
HER2-low tumor expression (IHC 2+/ISH-, IHC 1+/ISH-, or IHC 1+/ISH untested)
Participants will receive trastuzumab deruxtecan plus durvalumab for eight cycles prior to surgery (Cycle Length is 21 days)
After surgery, Participants will receive therapy per physician's choice and to reflect current standard of care.
Group II: HER2 PositiveExperimental Treatment2 Interventions
Participants will be enrolled into one of two cohorts: HER2 positive IBC (cohort 1) and HER2 low IBC (cohort 2).
HER2-positive determined locally by the current ASCO/CAP guidelines
Participants will receive trastuzumab deruxtecan plus durvalumab for eight cycles prior to surgery. (Cycle Length is 21 days)
After surgery, Participants will receive therapy per physician's choice and to reflect current standard of care.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trastuzumab deruxtecan
2022
Completed Phase 2
~400
Durvalumab
2017
Completed Phase 2
~3870
Find a Location
Who is running the clinical trial?
AstraZenecaIndustry Sponsor
4,272 Previous Clinical Trials
288,612,612 Total Patients Enrolled
173 Trials studying Breast Cancer
1,246,276 Patients Enrolled for Breast Cancer
Daiichi SankyoIndustry Sponsor
393 Previous Clinical Trials
416,238 Total Patients Enrolled
25 Trials studying Breast Cancer
17,564 Patients Enrolled for Breast Cancer
Filipa Lynce, MDLead Sponsor
1 Previous Clinical Trials
78 Total Patients Enrolled
1 Trials studying Breast Cancer
78 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have an active infection like TB, hepatitis B, or hepatitis C.I have had cancer spread to the lining of my brain and spinal cord.I know my cancer's ER and PR status.I agree to use birth control during and for 4 months after my treatment.I haven't had major heart issues or procedures in the last 6 months.I do not have any serious ongoing illnesses that could worsen my condition or affect my participation.I have had treatments like chemotherapy for my inflammatory breast cancer.I have not had major surgery in the last 4 weeks or have fully recovered from it.I have had radiotherapy or surgery for my inflammatory breast cancer, but not just a biopsy.I am allergic to durvalumab, trastuzumab deruxtecan, or similar medications.I do not have serious lung conditions or autoimmune diseases affecting my lungs.I have not received a live vaccine in the last 30 days.You have tested positive for HIV in the past.I have conditions that could affect my heart's rhythm.I have had a blood clot in the last 3 months.I haven't taken hydroxychloroquine in the last 14 days.You have a history of a current, ongoing immune system disorder.My heart's pumping ability is within the normal range.I had cancer before, but it was treated over 5 years ago and is unlikely to come back.I am not pregnant or breastfeeding and willing to use birth control during and after treatment.I haven't taken strong drugs affecting liver enzymes in the last 2 weeks.I agree to have two tumor biopsies if safe, and my old biopsy samples can be found.I weigh more than 30 kilograms.I agree to use effective birth control during and 7 months after the study.I understand the study requirements and agree to participate.I have not received any treatment for my condition.I have or had an autoimmune or inflammatory disorder.My cancer is HER2-positive or has low HER2 expression according to tests.I have been on steroids or other immune-weakening drugs for a condition in the last 2 years.I have or had lung inflammation treated with steroids, or it's suspected but not confirmed by scans.I was diagnosed with stage III inflammatory breast cancer in the last 6 months.My organ and bone marrow functions are normal.Your heart's electrical activity is prolonged during an EKG screening.I am fully active or able to carry out light work.I have been diagnosed with invasive breast cancer.I am a man or woman over 18 years old.Your heart is pumping normally, with a measurement of at least 50% within the last 28 days before joining the study.
Research Study Groups:
This trial has the following groups:- Group 1: HER2-Low
- Group 2: HER2 Positive
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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 potential dangers should be taken into consideration when treating HER2 Positive patients?
"There is a limited body of evidence suggesting that HER2 Positive could be safe, so it was allocated a score of 2."
Answered by AI
Does this medical trial currently have room for additional participants?
"In line with what's posted on clinicaltrials.gov, this trial is not currently seeking participants; the posting was created June 1st 2023 and last updated March 20th of the same year. Nevertheless, there are 3354 alternative trials actively accepting patients at present."
Answered by AI
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