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Durvalumab + Trastuzumab + Pertuzumab for Breast Cancer (DTP Trial)
DTP Trial Summary
This trial will test if adding durvalumab to standard HER2-targeted treatment improves outcomes for patients with HER2-enriched breast cancer.
DTP Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowDTP Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.DTP Trial Design
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Who is running the clinical trial?
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- You have had an organ transplant from another person.I am a woman over 18 years old.I haven't taken immunosuppressive drugs in the last 14 days.I am not currently undergoing any cancer treatments like chemotherapy or immunotherapy.I have or had an autoimmune or inflammatory disorder.You have a history of a weak immune system that you were born with.My heart pumps well, with an ejection fraction of 50% or more.I have not received a live vaccine in the last 30 days.I have not had major surgery within the last 28 days.My organs and bone marrow are working well.I do not have active infections like TB, hepatitis B, C, or HIV.Your heart's electrical activity, called the QT interval, is longer than 470 milliseconds when measured from 3 EKGs.I have a heart condition that needed recent treatment.I am postmenopausal or have a negative pregnancy test if premenopausal.My heart's pumping ability is below normal.My cancer is not driven by estrogen or progesterone.My breast cancer is HER2-enriched and HER2-amplified.You have experienced ongoing or unstable side effects from a different experimental drug you took before.I am willing and able to follow the study's treatment plan and attend all visits.My breast tumor is larger than 1 cm.Both of my breasts have cancers that qualify for the trial.I am fully active or can carry out light work.My cancer may or may not have spread to the lymph nodes.I am willing to give tissue samples for the study.
- Group 1: Durvalumab + Trastuzumab + Pertuzumab
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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
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."
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."
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."
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."
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."
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