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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
Must not have
Prior history of invasive breast cancer
Stage IV breast cancer (determined by AJCC staging system)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 39 months after study start
Awards & highlights
Pivotal Trial
No Placebo-Only Group
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.
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.
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 belowSelect...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had breast cancer before.
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My breast cancer is at stage IV.
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I haven't had cancer, except for non-melanoma skin cancer or in situ disease, in the last 3 years.
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I have a history of or currently have lung inflammation.
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I have been treated with anthracyclines, cyclophosphamide, or taxanes for cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 39 months after study start
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 39 months after study start
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
rate of pathologic complete response (pCR)
Secondary study objectives
Event-Free Survival
Invasive Disease-Free Survival (IDFS)
Overall Survival
Awards & Highlights
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.
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
~5810
Trastuzumab Deruxtecan
2021
Completed Phase 2
~100
Trastuzumab
2014
Completed Phase 4
~5190
Find a Location
Who is running the clinical trial?
Daiichi Sankyo, Inc.Industry Sponsor
389 Previous Clinical Trials
421,772 Total Patients Enrolled
27 Trials studying Breast Cancer
18,704 Patients Enrolled for Breast Cancer
AstraZenecaLead Sponsor
4,379 Previous Clinical Trials
288,739,390 Total Patients Enrolled
177 Trials studying Breast Cancer
1,245,039 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had cancer, except for non-melanoma skin cancer or in situ disease, in the last 3 years.I have a history of or currently have lung inflammation.I am fully active or restricted in physically strenuous activity but can do light work.I have received systemic therapy for breast cancer before.I had DCIS but did not have a mastectomy over 5 years ago.I have been treated with anthracyclines, cyclophosphamide, or taxanes for cancer.I have had breast cancer before.I am 18 years old or older.My breast cancer is HER2-positive and falls within specific stages as per the AJCC 8th edition.My breast cancer is at stage IV.My organs and bone marrow are working well.I can provide tissue samples for HER2 testing, or I might after talking to the study doctor.I am 18 years old or older.I am fully active or restricted in physically strenuous activity but can do light work.
Research Study Groups:
This trial has the following groups:- Group 1: Arm C
- Group 2: Arm A
- Group 3: Arm B
Awards:
This trial has 2 awards, including:- 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.
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.
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