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Durvalumab with Trastuzumab and Pertuzumab in HER2-Enriched Breast Cancer | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2

Durvalumab with Trastuzumab and Pertuzumab in HER2-Enriched Breast Cancer

Multicenter Phase II Trial of Durvalumab (MEDI4736) with Trastuzumab and Pertuzumab Combination in HER2-Enriched and HER2-Amplified Breast Cancer (DTP Trial)

NCT03820141•The Methodist Hospital Research Institute

View on ClinicalTrials.gov

Summary

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.

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.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•1. Female aged \>18 years at the time of study entry.
•2. Histologically confirmed HER2-enriched (by BluePrint) and HER2-amplified (ERBB2 mRNA \>7.5-10) breast cancer.
•3. Estrogen receptor and progesterone receptor negative.
•4. Primary tumor greater than 1 cm diameter, measured by clinical examination and mammography or echography.
•5. Any nodal status
•6. Bilateral breast cancers that individually meet eligibility criteria are allowed.
•7. Eastern Cooperative Oncology Group performance status of 0 or 1.
•8. Adequate organ and marrow function.
•9. Baseline left ventricular ejection fraction greater than or equal to 50%, as measured by multigated acquisition scan or echocardiogram.
•10. 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.
+2 more criteria

Exclusion Criteria

•1. Participation in another clinical study with an investigational product within 28 days prior to the first dose of study treatment.
•2. 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.
•3. Unresolved or unstable adverse events from prior administration of another investigational drug.
•4. Any concurrent chemotherapy, radiation therapy, immunotherapy, or biologic therapy for cancer treatment.
•5. Major surgical procedure (as defined by the investigator) within 28 days prior to the first dose of study treatment.
•6. History of allogenic organ transplantation.
•7. Active or prior documented autoimmune or inflammatory disorders.
•8. History of active primary immunodeficiency.
•9. Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus.
•10. Current or prior use of immunosuppressive medication within 14 days prior to the first dose of study treatment.
+6 more criteria

Locations (1)

Houston Methodist Cancer Center

Houston, Texas, United States

Key Dates

Start Date

March 3, 2020

Primary Completion Date

October 30, 2024

Completion Date

December 1, 2025

Last Updated

March 10, 2025

Enrollment

ESTIMATED participants

Conditions

Breast Cancer

Interventions

Durvalumab

DRUG

Trastuzumab

DRUG

Pertuzumab

DRUG

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Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 10, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Durvalumab with Trastuzumab and Pertuzumab in HER2-Enriched Breast Cancer

Inclusion Criteria

Exclusion Criteria

Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

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Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

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