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Monoclonal Antibodies

T-DXd +/− Pertuzumab for 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 ≥18 years of age
Pathologically documented breast cancer that is advanced or metastatic
Must not have
Ineligible for any of the agents on the study
Active or prior documented interstitial lung disease (ILD)/pneumonitis or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed up to approximately 104 months
Awards & highlights
Pivotal Trial

Summary

This trial will test a new cancer drug to see if it is effective and safe for patients with HER2-positive breast cancer.

Who is the study for?
This trial is for adults over 18 with HER2-positive metastatic breast cancer. They should have good organ and bone marrow function, an ECOG performance status of 0 or 1, and no prior advanced/metastatic breast cancer treatment except possibly one line of endocrine therapy. Prior neo-adjuvant or adjuvant treatments are okay if it's been over 6 months.
What is being tested?
The study tests the effectiveness and safety of Trastuzumab Deruxtecan (T-DXd), alone or with Pertuzumab, compared to a Taxane-based regimen including Trastuzumab and Pertuzumab as first-line treatments for metastatic HER2-positive breast cancer.
What are the potential side effects?
Potential side effects include reactions at the infusion site, lung issues like interstitial lung disease/pneumonitis, fatigue, nausea, blood cell count changes which can affect immunity and increase infection risk.

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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My breast cancer is confirmed to be advanced or has spread.
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My breast cancer is confirmed to be HER2-positive.
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My breast cancer is confirmed as hormone receptor positive or negative.
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My organs and bone marrow are functioning well.
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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not eligible for any of the treatments being studied.
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I have or had lung inflammation that's been confirmed or can't be ruled out.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed up to approximately 104 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed up to approximately 104 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) assessment
Secondary study objectives
Duration of Response (DoR) by BICR and Investigator Assessment
Immunogenicity of trastuzumab deruxtecan.
Objective Response Rate (ORR) by BICR and Investigator assessment
+7 more

Side effects data

From 2024 Phase 2 trial • 79 Patients • NCT04014075
65%
Nausea
44%
Vomiting
42%
Fatigue
38%
Anaemia
37%
Diarrhoea
35%
Weight Decreased
33%
Decreased Appetite
29%
Constipation
24%
Alopecia
18%
Platelet Count Decreased
16%
Hypokalaemia
16%
Neutrophil Count Decreased
16%
Aspartate Aminotransferase Increased
15%
Asthenia
14%
Abdominal Pain
11%
Cough
11%
Pyrexia
11%
White Blood Cell Count Decreased
11%
Blood Alkaline Phosphatase Increased
10%
Epistaxis
10%
Hypoalbuminaemia
10%
Neutropenia
10%
Gastrooesophageal Reflux Disease
10%
Alanine Aminotransferase Increased
9%
Dyspnoea
9%
Back Pain
9%
Headache
8%
Hypotension
8%
Hyponatraemia
8%
Dizziness
6%
Pneumonitis
6%
Ascites
6%
Urinary Retention
6%
Abdominal Pain Upper
6%
Dysphagia
6%
Covid-19
6%
Insomnia
6%
Thrombocytopenia
6%
Weight Increased
6%
Blood Bilirubin Increased
5%
Interstitial Lung Disease
5%
Acute Kidney Injury
5%
Device Related Infection
5%
Hypophosphataemia
5%
Depression
5%
Flatulence
5%
Mucosal Inflammation
5%
Blood Creatinine Increased
5%
Urinary Tract Infection
5%
Oedema Peripheral
3%
Pneumonia
3%
Disease Progression
3%
Malignant Neoplasm Progression
1%
Hyperpyrexia
1%
Colitis
1%
Haematemesis
1%
Wound Infection
1%
Bacterial Sepsis
1%
Staphylococcal Infection
1%
Covid-19 Pneumonia
1%
Intestinal Obstruction
1%
Animal Bite
1%
Enteritis
1%
Basal Ganglia Infarction
1%
Cerebrovascular Accident
1%
Generalised Tonic-Clonic Seizure
1%
Pulmonary Embolism
1%
Lymphangiosis Carcinomatosa
1%
Tumour Haemorrhage
1%
Bile Duct Stenosis
1%
Hepatotoxicity
1%
Hydronephrosis
1%
Urinary Tract Obstruction
1%
Exposure To Communicable Disease
1%
Device Occlusion
1%
Catheter Site Infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trastuzumab Deruxtecan

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Arm BExperimental Treatment2 Interventions
Trastuzumab deruxtecan (T-DXd) plus pertuzumab
Group II: Arm AExperimental Treatment2 Interventions
Trastuzumab deruxtecan (T-DXd) plus pertuzumab-matching placebo
Group III: Arm CActive Control3 Interventions
Standard of care (Taxane (paclitaxel or docetaxel), trastuzumab, and pertuzumab)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trastuzumab deruxtecan
2021
Completed Phase 2
~730
Pertuzumab
2014
Completed Phase 3
~7500
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Daiichi Sankyo, Inc.Industry Sponsor
389 Previous Clinical Trials
421,736 Total Patients Enrolled
26 Trials studying Breast Cancer
17,629 Patients Enrolled for Breast Cancer
AstraZenecaLead Sponsor
4,400 Previous Clinical Trials
289,121,591 Total Patients Enrolled
175 Trials studying Breast Cancer
1,243,071 Patients Enrolled for Breast Cancer

Media Library

Pertuzumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04784715 — Phase 3
Breast Cancer Research Study Groups: Arm A, Arm B, Arm C
Breast Cancer Clinical Trial 2023: Pertuzumab Highlights & Side Effects. Trial Name: NCT04784715 — Phase 3
Pertuzumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04784715 — Phase 3
~97 spots leftby Mar 2025
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