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

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.

Timeline

Start

2016-10-28

Primary completion

2020-10-31

Completion

2021-08-03

Outcome

Missed primary endpoint

Stopped: “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.”

paper The trial has not reached its primary endpoint. PMID 36879012 ↗

Publications

• Mamot C, Wicki A, Hasler-Strub U, Riniker S, Li Q, Holer L, Bartschi D, Zaman K, von Moos R, Dedes KJ, Boos LA, Novak U, Bodmer A, Ritschard R, Obermann EC, Tzankov A, Ackermann C, Membrez-Antonioli V, Zurrer-Hardi U, Caspar CB, Deuster S, Senn M, Winterhalder R, Rochlitz C. A multicenter phase II trial of anti-EGFR-immunoliposomes loaded with doxorubicin in patients with advanced triple negative breast cancer. Sci Rep. 2023 Mar 6;13(1):3705. doi: 10.1038/s41598-023-30950-z.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	anti-EGFR-IL-dox	Other / unclassified	50 mg/m2	Intravenous

Indications