Durvalumab With Trastuzumab and Pertuzumab in HER2-Enriched Breast Cancer

  • STATUS
    Recruiting
  • End date
    Aug 2, 2023
  • participants needed
    39
  • sponsor
    The Methodist Hospital Research Institute
Updated on 2 August 2021
estrogen
growth factor
progesterone
pertuzumab
epidermal growth factor receptor
HER2
trastuzumab
progesterone receptor
erbb2
epidermal growth factor
estrogen receptor

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.

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.

Details
Condition Breast Cancer, Breast Cancer Diagnosis, breast carcinoma, cancer, breast
Treatment Trastuzumab, durvalumab, Pertuzumab
Clinical Study IdentifierNCT03820141
SponsorThe Methodist Hospital Research Institute
Last Modified on2 August 2021

Eligibility

Yes No Not Sure

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
Stage I or II disease
Node-negative breast cancer according to the American Joint Committee on Cancer 7th Edition
T2 disease
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
Uncontrolled intercurrent illness including but not limited to ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirements, substantially increase the risk of incurring adverse events, or compromise the ability of the patient to give written informed consent
History of another primary malignancy except for: malignancy treated with curative intent and with no known active disease for more than 5 years before the first dose of study treatment and of low potential risk for recurrence
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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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