Anti-EGFR-immunoliposomes Loaded With Doxorubicin in Patients With Advanced Triple Negative EGFR Positive Breast Cancer
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|ClinicalTrials.gov Identifier: NCT02833766|
Recruitment Status : Recruiting
First Posted : July 14, 2016
Last Update Posted : September 18, 2018
|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)|
|Estimated Enrollment :||49 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 :||June 2019|
|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
|Contact: Martina Schneider||+41 31 389 91 firstname.lastname@example.org|
|Aarau, Switzerland, CH-5001|
|Contact: Christoph Mamot, MD +41 62 838 60 64 email@example.com|
|Principal Investigator: Christoph Mamot, MD|
|Baden, Switzerland, CH-5404|
|Contact: Clemens B. Caspar, MD 41-56-486-2762 firstname.lastname@example.org|
|Principal Investigator: Clemens Caspar, MD|
|Basel, Switzerland, 4031|
|Contact: Christoph Rochlitz, Prof +41 61 265 50 74 email@example.com|
|Principal Investigator: Christoph Rochlitz, Prof|
|Bern, Switzerland, CH-3010|
|Contact: Urban Novak, MD +41 31 632 19 92 firstname.lastname@example.org|
|Principal Investigator: Urban Novak, MD|
|Chur, Switzerland, CH-7000|
|Contact: Roger von Moos, MD +41 81 256 66 47 email@example.com|
|Principal Investigator: Roger von Moos, MD|
|Hopitaux Universitaires de Geneve||Recruiting|
|Genève 14, Switzerland, 1211|
|Contact: Alexandre Bodmer, MD +41 22 372 40 14 firstname.lastname@example.org|
|Principal Investigator: Alexandre Bodmer, MD|
|Centre Hospitalier Universitaire Vaudois||Recruiting|
|Lausanne, Switzerland, CH-1011|
|Contact: Khalil Zaman, MD 41-21-314-4658 email@example.com|
|Principal Investigator: Khalil Zaman, MD|
|Luzern, Switzerland, 6000|
|Contact: Ralph Winterhalder, MD +41 41 205 58 75 firstname.lastname@example.org|
|Principal Investigator: Ralph Winterhalder, MD|
|Olten, Switzerland, 4600|
|Contact: Catrina Uhlmann Nussbaum, MD +41 62 311 42 41 email@example.com|
|Principal Investigator: Catrina Uhlmann Nussbaum, MD|
|Hôpital de Sion||Recruiting|
|Contact: Véronique Membrez, MD +41 27 603 48 53 firstname.lastname@example.org|
|Principal Investigator: Véronique Membrez, MD|
|Kantonsspital St. Gallen||Recruiting|
|St. Gallen, Switzerland, 9007|
|Contact: Ursula Hasler-Strub, MD +41 71 494 19 32 email@example.com|
|Principal Investigator: Ursula Hasler-Strub, MD|
|Spital STS AG||Recruiting|
|Thun, Switzerland, CH-3600|
|Contact: Daniel Rauch, MD +41 33 226 26 45 firstname.lastname@example.org|
|Principal Investigator: Daniel Rauch, MD|
|Winterthur, Switzerland, 8401|
|Contact: Andreas Müller, MD +41 52 266 36 44 Andreas.email@example.com|
|Principal Investigator: Andreas Müller, MD|
|Onkozentrum - Klinik im Park||Withdrawn|
|Zurich, Switzerland, 8002|
|Zürich, Switzerland, 8091|
|Contact: Konstantin Dedes, MD +41 44 255 1613 Konstantin.firstname.lastname@example.org|
|Principal Investigator: Konstantin Dedes, MD|
|Study Chair:||Ralph Winterhalder, MD||Luzerner Kantonsspital|