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Monoclonal Antibodies

Durvalumab + Trastuzumab + Pertuzumab for Breast Cancer (DTP Trial)

Phase 2
Recruiting
Led By Jenny Chang, M.D.
Research Sponsored by The Methodist Hospital Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Female aged >18 years at the time of study entry
Baseline left ventricular ejection fraction greater than or equal to 50%, as measured by multigated acquisition scan or echocardiogram
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

DTP Trial Summary

This trial will test if adding durvalumab to standard HER2-targeted treatment improves outcomes for patients with HER2-enriched breast cancer.

Who is the study for?
This trial is for postmenopausal or non-pregnant premenopausal women over 18 with HER2-enriched and amplified breast cancer. Participants must have good heart function, organ and marrow health, and be able to follow the study protocol. Those with severe heart issues, recent major surgery, other treatments for cancer, autoimmune diseases, infections like TB or HIV, or on immunosuppressants can't join.Check my eligibility
What is being tested?
The trial tests the safety and effectiveness of combining durvalumab with trastuzumab and pertuzumab in treating HER2-enriched breast cancer. It aims to see how well these drugs work together against this specific type of breast cancer.See study design
What are the potential side effects?
Possible side effects include immune-related reactions affecting organs, infusion-related symptoms such as fever or chills, fatigue from treatment burden on the body's systems, potential blood disorders due to bone marrow impact by drugs.

DTP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a woman over 18 years old.
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My heart pumps well, with an ejection fraction of 50% or more.
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My organs and bone marrow are working well.
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I am postmenopausal or have a negative pregnancy test if premenopausal.
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My cancer is not driven by estrogen or progesterone.
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My breast cancer is HER2-enriched and HER2-amplified.
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I am willing and able to follow the study's treatment plan and attend all visits.
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My breast tumor is larger than 1 cm.
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Both of my breasts have cancers that qualify for the trial.
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I am fully active or can carry out light work.
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My cancer may or may not have spread to the lymph nodes.
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I am willing to give tissue samples for the study.

DTP Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pathological complete response (pCR) rate in the breast in patients with HER2-enriched and HER2-amplified breast cancer
Secondary outcome measures
Number of participants with treatment-related adverse events
Three-year disease-free survival (DFS) rate in patients who achieve pCR
Thrombopoietin
+1 more

DTP Trial Design

1Treatment groups
Experimental Treatment
Group I: Durvalumab + Trastuzumab + PertuzumabExperimental Treatment3 Interventions
Durvalumab, trastuzumab, and pertuzumab will be administered on Day 1 every 3 weeks for 6 cycles. Trastuzumab will be administered as 8 mg/kg intravenous (IV) loading dose, followed by 6 mg/kg IV. Pertuzumab will be administered as 840 mg IV loading dose, followed by 420 mg. Durvalumab will be administered at a fixed dose of 1120 mg IV.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
FDA approved
Pertuzumab
FDA approved
Trastuzumab
FDA approved

Find a Location

Who is running the clinical trial?

AstraZenecaIndustry Sponsor
4,243 Previous Clinical Trials
288,527,733 Total Patients Enrolled
173 Trials studying Breast Cancer
1,246,300 Patients Enrolled for Breast Cancer
The Methodist Hospital Research InstituteLead Sponsor
270 Previous Clinical Trials
80,209 Total Patients Enrolled
12 Trials studying Breast Cancer
312 Patients Enrolled for Breast Cancer
Jenny Chang, M.D.Principal InvestigatorHouston Methodist Cancer Center
2 Previous Clinical Trials
58 Total Patients Enrolled
1 Trials studying Breast Cancer
28 Patients Enrolled for Breast Cancer

Media Library

Durvalumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03820141 — Phase 2
Breast Cancer Research Study Groups: Durvalumab + Trastuzumab + Pertuzumab
Breast Cancer Clinical Trial 2023: Durvalumab Highlights & Side Effects. Trial Name: NCT03820141 — Phase 2
Durvalumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03820141 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are the researchers looking to accept into this clinical trial?

"Affirmative. Clinicaltrials.gov attests that this clinical research is currently recruiting volunteers, having been first posted on March 3rd 2020 and last edited August 5th 2022. The trial requires 39 participants across a single medical centre to be completed."

Answered by AI

Are there any additional studies conducted utilizing Durvalumab?

"Presently, 521 clinical studies are researching Durvalumab. Of those active trials, 101 are in the third phase of testing. The majority of these tests take place in Seattle, Washington but there exist over 27 thousand other sites running related experiments."

Answered by AI

Has the FDA given the greenlight to Durvalumab?

"Durvalumab's safety has been proven in prior clinical trials and thus it scored a 2. Unfortunately, there are yet to be any studies that confirm its efficacy."

Answered by AI

Are there any vacancies for enrolment in this experiment?

"According to the information presented on clinicaltrials.gov, this trial is currently open for enrollment. The protocol was initially uploaded on March 3rd 2020 and has been amended most recently on August 5th 2022."

Answered by AI

What maladies does Durvalumab typically combat?

"Durvalumab is a popular therapeutic option for treating maladies such as breast cancer, high risk of recurrence, and advance directives."

Answered by AI
~4 spots leftby Sep 2024