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Trial record 19 of 172 for:    pertuzumab

Durvalumab With Trastuzumab and Pertuzumab in HER2-Enriched Breast Cancer (DTP)

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ClinicalTrials.gov Identifier: NCT03820141
Recruitment Status : Not yet recruiting
First Posted : January 29, 2019
Last Update Posted : September 18, 2019
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Jenny C. Chang, MD, The Methodist Hospital System

Brief 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Durvalumab Drug: Trastuzumab Drug: Pertuzumab Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 39 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter Phase II Trial of Durvalumab (MEDI4736) With Trastuzumab and Pertuzumab Combination in HER2-Enriched and HER2-Amplified Breast Cancer (DTP Trial)
Estimated Study Start Date : December 2019
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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.
Drug: Durvalumab
programmed cell death-ligand 1 inhibitor
Other Name: IMFINZI, MEDI4736

Drug: Trastuzumab
anti-HER2 monoclonal antibody
Other Name: Herceptin

Drug: Pertuzumab
anti-HER2 monoclonal antibody
Other Name: Perjeta




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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. Stage I or II disease.
  5. Node-negative breast cancer according to the American Joint Committee on Cancer 7th Edition.
  6. T2 disease.
  7. Bilateral breast cancers that individually meet eligibility criteria are allowed.
  8. Eastern Cooperative Oncology Group performance status of 0 or 1.
  9. Adequate organ and marrow function.
  10. Baseline left ventricular ejection fraction greater than or equal to 50%, as measured by multigated acquisition scan or echocardiogram.
  11. 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.
  12. Willing to provide biopsy tissues as required by the study.
  13. 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:

  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. 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.
  9. 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.
  10. History of active primary immunodeficiency.
  11. Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus.
  12. Current or prior use of immunosuppressive medication within 14 days prior to the first dose of study treatment.
  13. Receipt of live attenuated vaccine within 30 days prior to the first dose of study treatment.
  14. 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.
  15. Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03820141


Contacts
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Contact: Houston Methodist Cancer Center 713-441-0629 ccresearch@houstonmethodist.org
Contact: Jenny Chang, M.D. 713-441-0629 ccresearch@houstonmethodist.org

Locations
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United States, Texas
Houston Methodist Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Jenny C. Chang, MD
AstraZeneca
Investigators
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Principal Investigator: Jenny Chang, M.D. Houston Methodist Cancer Center

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Responsible Party: Jenny C. Chang, MD, Director, Houston Methodist Cancer Center, The Methodist Hospital System
ClinicalTrials.gov Identifier: NCT03820141     History of Changes
Other Study ID Numbers: Pro00020917
First Posted: January 29, 2019    Key Record Dates
Last Update Posted: September 18, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pertuzumab
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Trastuzumab
Durvalumab
Antibodies, Monoclonal
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs