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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 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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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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 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

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

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
~24 spots leftby Dec 2024
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