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
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: anti-EGFR-IL-dox||Phase 2|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Metastatic, non resectable, EGFR positive TNBC patients treated in first-line
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
- 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.
- 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.
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
|Aarau, Switzerland, CH-5001|
|Baden, Switzerland, CH-5404|
|Basel, Switzerland, 4031|
|Bern, Switzerland, CH-3010|
|Chur, Switzerland, CH-7000|
|Hopitaux Universitaires de Geneve|
|Genève 14, Switzerland, 1211|
|Centre Hospitalier Universitaire Vaudois|
|Lausanne, Switzerland, CH-1011|
|Luzern, Switzerland, 6000|
|Olten, Switzerland, 4600|
|Hôpital de Sion|
|Kantonsspital St. Gallen|
|St. Gallen, Switzerland, 9007|
|Spital STS AG|
|Thun, Switzerland, CH-3600|
|Winterthur, Switzerland, 8401|
|Onkozentrum - Klinik im Park|
|Zurich, Switzerland, 8002|
|Zürich, Switzerland, 8091|
|Study Chair:||Ralph Winterhalder, MD||Luzerner Kantonsspital|