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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 : Terminated (the trial was prematurely terminated as per SAKK board decision from 14th of November 2020. The trial is to be terminated after primary endpoint is reached.)
First Posted : July 14, 2016
Last Update Posted : September 29, 2021
Sponsor:
Information provided by (Responsible Party):
Swiss Group for Clinical Cancer Research

Tracking Information
First Submitted Date  ICMJE July 12, 2016
First Posted Date  ICMJE July 14, 2016
Last Update Posted Date September 29, 2021
Actual Study Start Date  ICMJE October 28, 2016
Actual Primary Completion Date October 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 13, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 13, 2016)
  • 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.
  • 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.
  • 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.
  • 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.
  • Overall survival (OS) [ Time Frame: at 12 months after registration ]
    OS is defined as time from registration until death from any cause.
  • Adverse events (AEs) [ Time Frame: at 12 months after registration ]
    AE are assessed according to NCI CTCAE v4.0.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Anti-EGFR-immunoliposomes Loaded With Doxorubicin in Patients With Advanced Triple Negative EGFR Positive Breast Cancer
Official Title  ICMJE Anti-EGFR-immunoliposomes Loaded With Doxorubicin in Patients With Advanced Triple Negative EGFR Positive Breast Cancer - A Multicenter Single Arm Phase II Trial
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: anti-EGFR-IL-dox
Metastatic, non resectable, EGFR positive TNBC patients treated in first-line
Intervention: Drug: anti-EGFR-IL-dox
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 29, 2019)
48
Original Estimated Enrollment  ICMJE
 (submitted: July 13, 2016)
49
Actual Study Completion Date  ICMJE August 3, 2021
Actual Primary Completion Date October 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02833766
Other Study ID Numbers  ICMJE SAKK 24/14
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Swiss Group for Clinical Cancer Research
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Swiss Group for Clinical Cancer Research
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Ralph Winterhalder, MD Luzerner Kantonsspital
PRS Account Swiss Group for Clinical Cancer Research
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP