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Monoclonal Antibodies

T-DXd Combinations for Breast Cancer (DB-07 Trial)

Phase 1 & 2
Waitlist Available
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
At least 1 prior treatment line in metastatic setting required
Patients must have untreated brain metastases not needing local therapy or previously treated brain metastases that have progressed since prior local therapy for Module 6 and 7
Must not have
Prior treatment with tucatinib
Lung-specific intercurrent clinically significant illnesses
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed up to approximately 53 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will study whether T-DXd, in combination with other anti-cancer agents, is safe and effective in treating patients with HER2-positive Metastatic Breast Cancer.

Who is the study for?
This trial is for adults with HER2-positive metastatic breast cancer that's advanced or can't be surgically removed. Participants must have a performance status indicating they are fully active or restricted in physically strenuous activity but ambulatory. They should not have had certain prior treatments, need to have progressed after their last systemic therapy, and may only have stable brain metastases or none at all.
What is being tested?
DESTINY-Breast07 explores the effectiveness of trastuzumab deruxtecan (T-DXd) combined with other anti-cancer drugs like Tucatinib, Durvalumab, Paclitaxel, and Pertuzumab in treating HER2-positive metastatic breast cancer. The study aims to assess safety and how well tumors respond to these combinations.
What are the potential side effects?
Potential side effects include reactions related to immune system activation such as inflammation of organs, infusion-related symptoms, possible lung issues like pneumonitis which could require steroids if severe enough, heart problems due to cardiovascular stress from treatment, and infection risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have received at least one treatment for my cancer after it spread.
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I have brain metastases that haven't been treated or have worsened after treatment.
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My cancer cannot be removed by surgery and has spread.
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My cancer is HER2-positive from a test on a recent tumor sample.
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My cancer is hormone receptor-positive or negative in its advanced stage.
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I have a sufficient tumor sample available for testing.
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I do not have brain metastases or they are stable.
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I am 18 years old or older.
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My tumor tested positive for HER2 from a recent biopsy.
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My cancer is hormone receptor-positive or negative.
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I have had at most one treatment for my advanced/metastatic breast cancer.
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I have not received any treatments for my advanced/metastatic breast cancer.
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I can carry out all my daily activities without help.
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My breast cancer cannot be surgically removed or has spread.
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My condition worsened after my last treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been treated with tucatinib before.
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I have no serious lung illnesses besides my cancer.
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I have been treated with drugs that boost the immune system.
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I have or had lung inflammation that needed steroids.
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I do not have an infection needing IV drugs.
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I have serious heart problems that are not under control.
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I am taking more than 2 mg of dexamethasone daily for brain metastases symptoms.
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I have had spinal cord compression or cancer spread to the lining of my brain.
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I have been treated with a drug that targets cancer cells and carries a specific toxin.
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I have brain metastasis that has not been treated.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed up to approximately 53 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed up to approximately 53 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
Occurrence of adverse events (AEs)- Part 1
Occurrence of adverse events (AEs)- Part 2
Occurrence of serious adverse events (SAEs)- Part 1
+1 more
Secondary study objectives
Duration of Response (DoR)- Part 2
Immunogenicity of Durvalumab
Immunogenicity of Pertuzumab
+10 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

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

8Treatment groups
Experimental Treatment
Group I: Module 7 - T-DXdExperimental Treatment1 Intervention
T-DXd monotherapy in patients with active brain metastases (Part 2 Only)
Group II: Module 6 - T-DXd and TucatinibExperimental Treatment2 Interventions
T-DXd and tucatinib in patients with active brain metastases (Part 2 Only) (Arm not initiated)
Group III: Module 5 - T-DXd and TucatanibExperimental Treatment2 Interventions
T-DXd and tucatinib (Arm not initiated in Part 2)
Group IV: Module 4- T-DXd and Durvalumab and PaclitaxelExperimental Treatment3 Interventions
T-DXd and Durvalumab and Paclitaxel (Arm not initiated in Part 1 and Part 2)
Group V: Module 3- T-DXd and PaclitaxelExperimental Treatment2 Interventions
T-DXd and Paclitaxel (Arm not initiated in Part 2)
Group VI: Module 2- T-DXd and PertuzumabExperimental Treatment2 Interventions
T-DXd and Pertuzumab
Group VII: Module 1- T-DXd and DurvalumabExperimental Treatment2 Interventions
T-DXd and Durvalumab
Group VIII: Module 0- T-DXdExperimental Treatment1 Intervention
T-DXd
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tucatinib
2017
Completed Phase 2
~520
Trastuzumab deruxtecan
2021
Completed Phase 2
~730
Durvalumab
2017
Completed Phase 2
~3750
Paclitaxel
2011
Completed Phase 4
~5370
Pertuzumab
2014
Completed Phase 3
~7500

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,390 Previous Clinical Trials
289,108,890 Total Patients Enrolled
175 Trials studying Breast Cancer
1,243,021 Patients Enrolled for Breast Cancer
Daiichi Sankyo Company, LimitedUNKNOWN
1 Previous Clinical Trials
138 Total Patients Enrolled

Media Library

Pertuzumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04538742 — Phase 1 & 2
Breast Cancer Research Study Groups: Module 5 - T-DXd and Tucatanib, Module 7 - T-DXd, Module 4- T-DXd and Durvalumab and Paclitaxel, Module 6 - T-DXd and Tucatinib, Module 1- T-DXd and Durvalumab, Module 2- T-DXd and Pertuzumab, Module 3- T-DXd and Paclitaxel, Module 0- T-DXd
Breast Cancer Clinical Trial 2023: Pertuzumab Highlights & Side Effects. Trial Name: NCT04538742 — Phase 1 & 2
Pertuzumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04538742 — Phase 1 & 2
~10 spots leftby Jan 2025
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