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

NCT02833766 | Terminated Phase 2

• 1 other identifier: SAKK 24/14
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 15

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.

Conditions

Breast Cancer

Keywords

Breast Cancer; advanced triple Negative, EGFR positive breast cancer; doxorubicin; triple negative breast cancer (TNBC)

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  PFS is defined as the time from registration until progression according to RECIST v1.1 or death from any cause, whichever occurs first.

  at 12 months after registration

Secondary Outcomes (6)

• Objective response rate (ORR)

  at 12 months after registration

• Duration of response (DOR)

  at 12 months after registration

• Time to Progression (TTP)

  at 12 months after registration

• PFS

  at 12 months after registration

• Overall survival (OS)

  at 12 months after registration

Study Arms (1)

anti-EGFR-IL-dox

EXPERIMENTAL

Metastatic, non resectable, EGFR positive TNBC patients treated in first-line

Drug: anti-EGFR-IL-dox

Interventions

anti-EGFR-IL-dox DRUG

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

Also known as: anti-EGFR-immunoliposomes loaded with doxorubicin

anti-EGFR-IL-dox

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Evidence of CNS or leptomeningeal metastases (even if previously treated); CNS imaging not required in asymptomatic patients
• 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.

Sponsors & Collaborators

• Swiss Cancer Institute: lead

Study Sites (15)

Kantonsspital Aarau

Aarau, CH-5001, Switzerland

Location

Kantonsspital Baden

Baden, CH-5404, Switzerland

Location

Universitaetsspital-Basel

Basel, 4031, Switzerland

Location

Inselspital, Bern

Bern, CH-3010, Switzerland

Location

Kantonsspital Graubuenden

Chur, CH-7000, Switzerland

Location

Hopitaux Universitaires de Geneve

Geneva, 1211, Switzerland

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, CH-1011, Switzerland

Location

Kantonsspital Luzern

Lucerne, 6000, Switzerland

Location

Kantonsspital Olten

Olten, 4600, Switzerland

Location

Kantonsspital St. Gallen

Sankt Gallen, 9007, Switzerland

Location

Hôpital de Sion

Sion, Switzerland

Location

Spital STS AG

Thun, CH-3600, Switzerland

Location

Kantonsspital Winterthur

Winterthur, 8401, Switzerland

Location

Onkozentrum - Klinik im Park

Zurich, 8002, Switzerland

Location

Universitätsspital Zürich

Zurich, 8091, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 36879012 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Triple Negative Breast Neoplasms

Interventions

Doxorubicin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Ralph Winterhalder, MD

  Luzerner Kantonsspital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2016
• First Posted: July 14, 2016
• Study Start: October 28, 2016
• Primary Completion: October 31, 2020
• Study Completion: August 3, 2021
• Last Updated: September 29, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (15)