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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed up to approximately 104 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am 18 years old or older.
Select...
My breast cancer is confirmed to be advanced or has spread.
Select...
My breast cancer is confirmed to be HER2-positive.
Select...
My breast cancer is confirmed as hormone receptor positive or negative.
Select...
My organs and bone marrow are functioning well.
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I am fully active or can carry out light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ assessed up to approximately 104 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed up to approximately 104 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) assessment
Secondary outcome measures
Duration of Response (DoR) by BICR and Investigator Assessment
Immunogenicity of trastuzumab deruxtecan.
Objective Response Rate (ORR) by BICR and Investigator assessment
+7 moreSide effects data
From 2024 Phase 2 trial • 79 Patients • NCT0401407565%
Nausea
44%
Vomiting
42%
Fatigue
38%
Anaemia
37%
Diarrhoea
35%
Weight Decreased
33%
Decreased Appetite
29%
Constipation
24%
Alopecia
18%
Platelet Count Decreased
16%
Neutrophil Count Decreased
16%
Aspartate Aminotransferase Increased
16%
Hypokalaemia
15%
Asthenia
14%
Abdominal Pain
11%
Pyrexia
11%
Cough
11%
White Blood Cell Count Decreased
11%
Blood Alkaline Phosphatase Increased
10%
Neutropenia
10%
Hypoalbuminaemia
10%
Epistaxis
10%
Gastrooesophageal Reflux Disease
10%
Alanine Aminotransferase Increased
9%
Back Pain
9%
Dyspnoea
9%
Headache
8%
Hyponatraemia
8%
Hypotension
8%
Dizziness
6%
Urinary Retention
6%
Ascites
6%
Pneumonitis
6%
Abdominal Pain Upper
6%
Dysphagia
6%
Covid-19
6%
Insomnia
6%
Thrombocytopenia
6%
Weight Increased
6%
Blood Bilirubin Increased
5%
Acute Kidney Injury
5%
Interstitial Lung Disease
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%
Colitis
1%
Wound Infection
1%
Covid-19 Pneumonia
1%
Hyperpyrexia
1%
Staphylococcal Infection
1%
Haematemesis
1%
Bacterial Sepsis
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
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
2022
Completed Phase 2
~400
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
419,163 Total Patients Enrolled
28 Trials studying Breast Cancer
19,602 Patients Enrolled for Breast Cancer
AstraZenecaLead Sponsor
4,271 Previous Clinical Trials
288,611,725 Total Patients Enrolled
174 Trials studying Breast Cancer
1,246,339 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My organs and bone marrow are functioning well.I have or had lung inflammation that's been confirmed or can't be ruled out.My breast cancer is confirmed to be HER2-positive.I am 18 years old or older.I haven't had chemo or HER2 therapy for advanced breast cancer, but may have had one hormone treatment.You have been part of a previous study for trastuzumab deruxtecan, no matter which treatment you received.I am fully active or can carry out light work.My breast cancer is confirmed to be advanced or has spread.My breast cancer is confirmed as hormone receptor positive or negative.I am not eligible for any of the treatments being studied.I do not have active brain or spinal cord cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A
- Group 2: Arm B
- Group 3: Arm C
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there previous case studies of Trastuzumab deruxtecan?
"Trastuzumab deruxtecan was first researched in 1999 at Ospedale di Circolo e Fondazione Macchi. Since then, there have been a total of 18612 completed clinical trials. As of now, 237 studies are still ongoing, many of which are based in New Hyde Park, Louisiana."
Answered by AI
How do I know if I am able to join this particular clinical trial?
"This study is looking for 1134 individuals that have metastatic breast cancer that is HER2 positive. The patients must be 18 years old and 130. More specifically, the patients should: be in advanced or metastatic stages, have adequate organ and bone marrow function, be HER2-positive (IHC3+ or ISH+), be HR-positive or HR-negative, have not received chemotherapy or HER2-targeted therapy before, have an ECOG performance status of 0 or 1."
Answered by AI
Are there any availabilities for new participants in this clinical trial?
"Correct. The clinical trial, which was first posted on 2021-04-26 and last updated on 2022-10-17, is currently recruiting patients. They are looking for 1134 patients from 46 different locations."
Answered by AI
What is the official stance of the FDA on Trastuzumab deruxtecan?
"There is some efficacy data and multiple data sets supporting safety, so Trastuzumab deruxtecan was given a score of 3 for safety."
Answered by AI
At how many hospitals is this particular clinical trial being conducted?
"This study is available at 46 sites. The locations include New Hyde Park, Baton Rouge, and Halifax. There are also other locations in close proximity. If you enroll, it is recommended you choose the location nearest to you to avoid extensive travelling."
Answered by AI
What is trastuzumab deruxtecan used to treat most frequently?
"Trastuzumab deruxtecan is most commonly used to treat breast cancer. However, this medication can also be used as a preventative measure for patients with a high risk of cancer recurrence, as a first line of treatment, or post-surgery."
Answered by AI
Will this experiment be testing on individuals who are over 45 years old?
"Eligibility requirements for this study include being over 18 years old and under 130 years old."
Answered by AI
Who else is applying?
What site did they apply to?
Research Site
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I am curious. Enhertu is an option for me.
PatientReceived 2+ prior treatments
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