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Anti-EGFR-immunoliposomes Loaded With Doxorubicin in Patients With Advanced Triple Negative EGFR Positive Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02833766
Recruitment Status : Active, not recruiting
First Posted : July 14, 2016
Last Update Posted : April 24, 2020
Sponsor:
Information provided by (Responsible Party):
Swiss Group for Clinical Cancer Research

Brief Summary:
The main objective of the trial is to determine the efficacy of doxorubicin-loaded anti-EGFR immunoliposomes as first-line therapy in patients with advanced triple Negative, EGFR positive breast cancer. In this proof of concept trial, all patients will have an administration of the doxorubicin-loaded anti-EGFR immunoliposomes (anti-EGFR-IL-dox) every 28 days, until progression or unacceptable toxicity.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: anti-EGFR-IL-dox Phase 2

Detailed Description:

Advanced triple negative breast cancer (TNBC) is a highly chemosensitive disease displaying a dismal short-term prognosis with more than three quarters of patients in progression 12 months after the initiation of conventional chemotherapy. Approximately 2/3 of TNBC are expressing EGFR and breast cancer, including TNBC, is a disease highly sensitive to anthracyclines. Furthermore, data from a phase I trial, in 26 patients with different solid tumors, show very little toxicity and signs of efficacy of anti-EGFR-IL-dox.

The EGFR assessment will be performed centrally and only patients with EGFR positive tumors will be included. The patients will be treated with the anti-EGFR-IL-dox until progression and followed-up according to standard practice for patient with TNBC.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Anti-EGFR-immunoliposomes Loaded With Doxorubicin in Patients With Advanced Triple Negative EGFR Positive Breast Cancer - A Multicenter Single Arm Phase II Trial
Actual Study Start Date : October 28, 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: anti-EGFR-IL-dox
Metastatic, non resectable, EGFR positive TNBC patients treated in first-line
Drug: anti-EGFR-IL-dox
First-line treatment with anti-EGFR-IL-dox, given at a dose of 50 mg/m2 intravenous, on day 1 of each cycle, cycle length is 28 days
Other Name: anti-EGFR-immunoliposomes loaded with doxorubicin




Primary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: at 12 months after registration ]
    PFS is defined as the time from registration until progression according to RECIST v1.1 or death from any cause, whichever occurs first.


Secondary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: at 12 months after registration ]
    ORR is defined as proportion of patients achieving complete response (CR) or partial response (PR) according to RECIST v1.1 during trial treatment.

  2. Duration of response (DOR) [ Time Frame: at 12 months after registration ]
    DOR is defined as time from the date when a patient first meets the criteria for CR or PR according to RECIST v1.1, until documented progression, relapse or death due to disease progression, whichever occurs first.

  3. Time to Progression (TTP) [ Time Frame: at 12 months after registration ]
    Time to Progression (TTP), defined as the time from registration until progression TTP assessed according to RECIST v1.1 or death due to disease progression, whichever occurs first.

  4. PFS [ Time Frame: at 12 months after registration ]
    PFS is defined as the time from registration until progression according to RECIST v1.1 or death from any cause, whichever occurs first.

  5. Overall survival (OS) [ Time Frame: at 12 months after registration ]
    OS is defined as time from registration until death from any cause.

  6. Adverse events (AEs) [ Time Frame: at 12 months after registration ]
    AE are assessed according to NCI CTCAE v4.0.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Written informed consent according to ICH/GCP regulations before prescreening and registration and prior to any trial specific procedures, including participation in mandatory translational research
  • Histologically proven diagnosis of TNBC in metastatic or locally advanced non operable stage
  • EGFR expression in primary tumor or metastases of at least (1+) in immunohistochemistry, assessed by central pathologist
  • Measurable or evaluable disease according to RECIST 1.1
  • No prior systemic treatment for metastatic or inoperable disease
  • Adequate bone marrow function: neutrophils ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L
  • Adequate hepatic function: total bilirubin ≤ 1.5 x ULN; AST, ALT and AP ≤ 2.5 x ULN (AST, ALT and AP ≤ 5 x ULN if hepatic metastases are the only reason for enzyme elevation)
  • Adequate renal function: serum creatinine ≤ 1.5 x ULN and calculated creatinine clearance > 30 mL/min, according to the formula of Cockcroft-Gault.
  • Adequate cardiac function: Left Ventricular Ejection Fraction (LVEF) ≥ 40% as determined by either echocardiography (ECHO) or radionuclide angiocardiography (MUGA)

Exclusion Criteria:

  • Evidence of CNS or leptomeningeal metastases (even if previously treated); CNS imaging not required in asymptomatic patients
  • History of hematologic or primary solid tumor malignancy, unless in remission for at least 5 years from registration. Inclusion of adequately treated cervical carcinoma in situ or localized non-melanoma skin cancer is permitted independent of time since diagnosis
  • Previous therapy with more than 240 mg/m2 of doxorubicin or more than 450 mg/m2 of epirubicin
  • Previous radiotherapy for the metastatic disease (palliative radiotherapy of only non-target lesions is allowed)
  • Adjuvant treatment must have been stopped at least 6 months before registration
  • Any serious underlying medical condition (at the judgement of the investigator) which could impair the ability of the patient to participate in the trial (e.g. active autoimmune disease, uncontrolled diabetes, etc.)
  • Breastfeeding
  • Participation in any investigational drug trial within 4 weeks preceding treatment start
  • Any concomitant drugs contraindicated when administering Erbitux™ or Caelyx™ according to the Swissmedic-approved product information
  • Known hypersensitivity to trial drug(s) or to any component of the trial drug(s)
  • Any other serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the investigator may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications.

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): NCT02833766


Locations
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Switzerland
Kantonsspital Aarau
Aarau, Switzerland, CH-5001
Kantonsspital Baden
Baden, Switzerland, CH-5404
Universitaetsspital-Basel
Basel, Switzerland, 4031
Inselspital, Bern
Bern, Switzerland, CH-3010
Kantonsspital Graubuenden
Chur, Switzerland, CH-7000
Hopitaux Universitaires de Geneve
Genève 14, Switzerland, 1211
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, CH-1011
Kantonsspital Luzern
Luzern, Switzerland, 6000
Kantonsspital Olten
Olten, Switzerland, 4600
Hôpital de Sion
Sion, Switzerland
Kantonsspital St. Gallen
St. Gallen, Switzerland, 9007
Spital STS AG
Thun, Switzerland, CH-3600
Kantonsspital Winterthur
Winterthur, Switzerland, 8401
Onkozentrum - Klinik im Park
Zurich, Switzerland, 8002
Universitätsspital Zürich
Zürich, Switzerland, 8091
Sponsors and Collaborators
Swiss Group for Clinical Cancer Research
Investigators
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Study Chair: Ralph Winterhalder, MD Luzerner Kantonsspital
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Responsible Party: Swiss Group for Clinical Cancer Research
ClinicalTrials.gov Identifier: NCT02833766    
Other Study ID Numbers: SAKK 24/14
First Posted: July 14, 2016    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Swiss Group for Clinical Cancer Research:
Breast Cancer
advanced triple Negative, EGFR positive breast cancer
doxorubicin
triple negative breast cancer (TNBC)
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action