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Breast CancerPhase 2NCT02833766

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

A Phase 2 study testing anti-EGFR-IL-dox in people with Breast Cancer, run by Swiss Cancer Institute at 15 sites in Switzerland.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
What is being tested?
anti-EGFR-IL-dox
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
15 sitesSwitzerland
Study dates
28 Oct 2016to 3 Aug 2021
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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)

Who cannot join

  • 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.)
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  • 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.

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

Switzerland15 sites

  • Kantonsspital Aarau

    Aarau, CH-5001

  • Kantonsspital Baden

    Baden, CH-5404

  • Universitaetsspital-Basel

    Basel, 4031

  • Inselspital, Bern

    Bern, CH-3010

  • Kantonsspital Graubuenden

    Chur, CH-7000

  • Hopitaux Universitaires de Geneve

    Geneva, 1211

  • Centre Hospitalier Universitaire Vaudois

    Lausanne, CH-1011

  • Kantonsspital Luzern

    Lucerne, 6000

  • Kantonsspital Olten

    Olten, 4600

  • Kantonsspital St. Gallen

    Sankt Gallen, 9007

  • Hôpital de Sion

    Sion

  • Spital STS AG

    Thun, CH-3600

  • Kantonsspital Winterthur

    Winterthur, 8401

  • Onkozentrum - Klinik im Park

    Zurich, 8002

  • Universitätsspital Zürich

    Zurich, 8091

Other trials in Switzerland

About this study

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

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.

Read the 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.

Conditions
Breast Cancer
Being tested
anti-EGFR-IL-dox
Keywords
Breast Cancer, advanced triple Negative, EGFR positive breast cancer, doxorubicin, triple negative breast cancer (TNBC)
Medical subject headings
Breast Neoplasms, Triple Negative Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • anti-EGFR-IL-doxDrug

    Also called anti-EGFR-immunoliposomes loaded with doxorubicin

    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

Study groups in NCT02833766
Study groupRoleWhat they receive
anti-EGFR-IL-doxExperimentalMetastatic, non resectable, EGFR positive TNBC patients treated in first-line
Receives: Drug: anti-EGFR-IL-dox

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: at 12 months after registration

Secondary outcomes (6)

  1. Objective response rate (ORR)

    ORR is defined as proportion of patients achieving complete response (CR) or partial response (PR) according to RECIST v1.1 during trial treatment.

    Measured: at 12 months after registration

  2. Duration of response (DOR)

    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.

    Measured: at 12 months after registration

  3. Time to Progression (TTP)

    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.

    Measured: at 12 months after registration

  4. PFS

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

    Measured: at 12 months after registration

  5. Overall survival (OS)

    OS is defined as time from registration until death from any cause.

    Measured: at 12 months after registration

  6. Adverse events (AEs)

    AE are assessed according to NCI CTCAE v4.0.

    Measured: at 12 months after registration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2016 (estimated)
  2. Study start28 Oct 2016
  3. Primary completion31 Oct 2020
  4. Study completion3 Aug 2021

Why it 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.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02833766
Sponsor's protocol ID
SAKK 24/14
Status last verified
Sep 2021
First submitted
12 Jul 2016
Last updated
29 Sep 2021
Results posted
No
Data monitoring committee
No
Individual data sharing
No

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.

    PubMed 36879012

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing anti-EGFR-IL-dox in people with Breast Cancer, run by Swiss Cancer Institute at 15 sites in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: 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.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) (time frame: at 12 months after registration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02833766, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2021.

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