- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03820141
Durvalumab With Trastuzumab and Pertuzumab in HER2-Enriched Breast Cancer (DTP)
September 15, 2023 updated by: Jenny C. Chang, MD, The Methodist Hospital Research Institute
Multicenter Phase II Trial of Durvalumab (MEDI4736) With Trastuzumab and Pertuzumab Combination in HER2-Enriched and HER2-Amplified Breast Cancer (DTP Trial)
The purpose of this research study is to test the safety and effectiveness of using durvalumab with trastuzumab and pertuzumab in participants with human epidermal growth factor receptor 2 (HER2)-enriched breast cancer.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
The purpose of this research study is to test the safety and effectiveness of using durvalumab with trastuzumab and pertuzumab in participants with HER2-enriched breast cancer.
The standard or usual pre-surgery treatment for this type of disease are drugs called trastuzumab and pertuzumab that target HER2.
Studies have shown that trastuzumab and pertuzumab treatment can stimulate the body's own immune system to attack cancer cells.
Durvalumab is a drug that also activates the immune system.
The use of durvalumab together with trastuzumab and pertuzumab treatment may allow the immune system to work harder to kill cancer cells.
Study Type
Interventional
Enrollment (Estimated)
39
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Houston Methodist Cancer Center
- Phone Number: 713-441-0629
- Email: ccresearch@houstonmethodist.org
Study Contact Backup
- Name: Jenny Chang, M.D.
- Phone Number: 713-441-0629
- Email: ccresearch@houstonmethodist.org
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- Recruiting
- Houston Methodist Cancer Center
-
Contact:
- Jenny C Chang, MD
- Phone Number: 713-441-0629
- Email: ccresearch@houstonmethodist.org
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Female aged >18 years at the time of study entry.
- Histologically confirmed HER2-enriched (by BluePrint) and HER2-amplified (ERBB2 mRNA >7.5-10) breast cancer.
- Estrogen receptor and progesterone receptor negative.
- Primary tumor greater than 1 cm diameter, measured by clinical examination and mammography or echography.
- Any nodal status
- Bilateral breast cancers that individually meet eligibility criteria are allowed.
- Eastern Cooperative Oncology Group performance status of 0 or 1.
- Adequate organ and marrow function.
- Baseline left ventricular ejection fraction greater than or equal to 50%, as measured by multigated acquisition scan or echocardiogram.
- Evidence of postmenopausal status or negative serum pregnancy test for premenopausal patients. Negative serum beta-human chorionic gonadotropin pregnancy test within 7 days prior to the first dose of study treatment for premenopausal patients.
- Willing to provide biopsy tissues as required by the study.
- Willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow-up.
Exclusion Criteria:
- Participation in another clinical study with an investigational product within 28 days prior to the first dose of study treatment.
- Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.
- Unresolved or unstable adverse events from prior administration of another investigational drug.
- Any concurrent chemotherapy, radiation therapy, immunotherapy, or biologic therapy for cancer treatment.
- Major surgical procedure (as defined by the investigator) within 28 days prior to the first dose of study treatment.
- History of allogenic organ transplantation.
- Active or prior documented autoimmune or inflammatory disorders.
- History of active primary immunodeficiency.
- Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus.
- Current or prior use of immunosuppressive medication within 14 days prior to the first dose of study treatment.
- Receipt of live attenuated vaccine within 30 days prior to the first dose of study treatment.
- Patients who are pregnant or breastfeeding or patients of reproductive potential who are not willing to employ effective birth control from screening to 7 months after the last dose of study treatment.
- Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
- Patients with a mean QT interval of greater than or equal to 470ms calculated from 3 EKGs
- Patients with underlying cardiovascular conditions that have recently undergone interventions including: cardiac ventricular arrhythmia requiring medication, history of second or third degree AV blocks, myocardial infarction with the previous year, congestive heart failure, and unstable angina
- Patients with a LVEF less than 50%
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Durvalumab + Trastuzumab + Pertuzumab
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.
|
anti-HER2 monoclonal antibody
Other Names:
programmed cell death-ligand 1 inhibitor
Other Names:
anti-HER2 monoclonal antibody
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pathological complete response (pCR) rate in the breast in patients with HER2-enriched and HER2-amplified breast cancer
Time Frame: 18 weeks
|
Determine pCR rate in the breast in patients with HER2-enriched and HER2-amplified breast cancer
|
18 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pCR rate in the breast in patients whose tumors have <5% and ≥5% tumor-infiltrating lymphocytes (TILs)
Time Frame: 18 weeks
|
Determine pCR rate in the breast in patients whose tumors have <5% and ≥5% TILs
|
18 weeks
|
pCR rate in patients with programmed cell death-ligand 1 (PD-L1)-positive and PD-L1-negative tumors
Time Frame: 18 weeks
|
Determine pCR rate in the breast in patients with PD-L1-positive and PD-L1-negative tumors
|
18 weeks
|
Three-year disease-free survival (DFS) rate in patients who achieve pCR
Time Frame: 3 years
|
Determination of 3-year DFS rate in patients who achieve pCR
|
3 years
|
Number of participants with treatment-related adverse events
Time Frame: 18 weeks
|
Number of participants with treatment-related adverse events, as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events v5.0
|
18 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Jenny Chang, M.D., Houston Methodist Cancer Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 3, 2020
Primary Completion (Estimated)
September 1, 2024
Study Completion (Estimated)
February 1, 2025
Study Registration Dates
First Submitted
January 25, 2019
First Submitted That Met QC Criteria
January 25, 2019
First Posted (Actual)
January 29, 2019
Study Record Updates
Last Update Posted (Actual)
September 18, 2023
Last Update Submitted That Met QC Criteria
September 15, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00020917
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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