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Chemotherapy

Trastuzumab Deruxtecan for Early Stage Breast Cancer

Phase 3
Recruiting
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must be at least 18 years of age.
ECOG performance status of 0 or 1 at randomization
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 39 months after study start
Awards & highlights

Study Summary

This trial will study if a new cancer drug is effective and safe to use in patients with early stage breast cancer.

Who is the study for?
This trial is for adults with high-risk, HER2-positive early breast cancer that hasn't spread (non-metastatic). Participants should have a certain level of tumor size and lymph node involvement, be in good physical condition (ECOG 0 or 1), have normal organ and bone marrow function, heart efficiency (LVEF ≥ 50%), and available tissue samples. Those with prior breast cancer treatment, stage IV cancer, other recent cancers except some skin cancers or in situ diseases, past anthracycline/cyclophosphamide/taxane use for any cancer are excluded.Check my eligibility
What is being tested?
The study tests the effectiveness and safety of Trastuzumab Deruxtecan (T-DXd) alone or followed by THP compared to standard treatment ddAC-THP in treating HER2-positive early-stage breast cancer before surgery. It aims to see if T-DXd can improve outcomes when used at an earlier stage of treatment.See study design
What are the potential side effects?
Possible side effects include reactions related to infusion treatments such as fatigue, nausea, hair loss from chemotherapy drugs like doxorubicin and cyclophosphamide; heart issues from trastuzumab; neuropathy from paclitaxel; and lung problems like ILD/pneumonitis which could be severe.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I am 18 years old or older.
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My breast cancer is HER2-positive and falls within specific stages as per the AJCC 8th edition.
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I am fully active or restricted in physically strenuous activity but can do light work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 39 months after study start
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 39 months after study start for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
rate of pathologic complete response (pCR)
Secondary outcome measures
Event-Free Survival
Invasive Disease-Free Survival (IDFS)
Overall Survival

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Arm BExperimental Treatment4 Interventions
T-DXd, followed by THP
Group II: Arm AExperimental Treatment1 Intervention
Trastuzumab deruxtecan
Group III: Arm CActive Control5 Interventions
doxorubicin and cyclophosphamide, followed by THP
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pertuzumab
2014
Completed Phase 3
~7500
Paclitaxel
2011
Completed Phase 4
~5380
Trastuzumab Deruxtecan
2021
Completed Phase 3
~510
Trastuzumab
2014
Completed Phase 4
~5190

Find a Location

Who is running the clinical trial?

Daiichi Sankyo, Inc.Industry Sponsor
389 Previous Clinical Trials
419,397 Total Patients Enrolled
27 Trials studying Breast Cancer
18,702 Patients Enrolled for Breast Cancer
AstraZenecaLead Sponsor
4,267 Previous Clinical Trials
288,611,298 Total Patients Enrolled
173 Trials studying Breast Cancer
1,245,439 Patients Enrolled for Breast Cancer

Media Library

Cyclophosphamide (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT05113251 — Phase 3
Breast Cancer Research Study Groups: Arm C, Arm A, Arm B
Breast Cancer Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT05113251 — Phase 3
Cyclophosphamide (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05113251 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any severe dangers that have been associated with Trastuzumab Deruxtecan?

"Trastuzumab Deruxtecan's safety has been vouched for by multiple rounds of clinical trials, so it received a score of 3."

Answered by AI

How many individuals are receiving treatment as part of this clinical trial?

"That is correct. The listing on clinicaltrials.gov indicates that this study is ongoing and actively recruiting patients. This particular trial was posted on October 25th, 2021 and was last edited on October 17th, 2020. There are a total of 624 patients needed to be enrolled across 34 different sites."

Answered by AI

What is the current understanding of Trastuzumab Deruxtecan's efficacy?

"At the moment, there are 1938 clinical trials underway that are studying Trastuzumab Deruxtecan. Of these trials, 423 are in Phase 3. The majority of the studies for Trastuzumab Deruxtecan are located in Seattle, Washington, but there are 78310 locations running studies for Trastuzumab Deruxtecan."

Answered by AI

What is the geographical dispersion of this experiment?

"Right now, this clinical trial is enrolling patients at 34 sites. Some of these sites are in Springdale, Shreveport, and Fort Wayne while the rest are located in other cities. If you want to enroll, try to pick a clinic that is close to your location to reduce travel time and effort."

Answered by AI

Are any places still available for people who want to participate in this experiment?

"Yes, current information on clinicaltrials.gov indicates that this study is looking for more patients. The trial was first posted on October 25th, 2021 and was last edited on October 17th, 2022. In total, they need 624 participants from 34 locations."

Answered by AI

What does Trastuzumab Deruxtecan usually help patients with?

"Trastuzumab Deruxtecan can be used to target and treat various forms of cancer, including leukemia, kaposi's sarcoma aids related, and cyclophosphamide."

Answered by AI

Does this study break new ground?

"Trastuzumab Deruxtecan has been the focus of 1938 active clinical trials in 83 countries and 3700 cities. The first study was sponsored by Alfacell and completed in 1997 after running Phase 3 drug approval with 300 patients. 2647 studies have been completed in the 24 years since."

Answered by AI

Who else is applying?

What state do they live in?
Texas
California
How old are they?
65+
18 - 65
What site did they apply to?
Research Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Recent research and studies
clinicaltrials.govStudy
Trastuzumab Deruxtecan (T-DXd) Alone or in Sequence With THP, Versus Standard Treatment (ddAC-THP), in HER2-positive Early Breast Cancer
2021. "Trastuzumab Deruxtecan (T-DXd) Alone or in Sequence With THP, Versus Standard Treatment (ddAC-THP), in HER2-positive Early Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05113251.
All > Breast Cancer High Point > Breast Cancer
~170 spots leftby Dec 2024
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