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Breast CancerPhase 2TREAT-CTCNCT01548677

Efficacy Study of Herceptin to Treat HER2-negative CTC Breast Cancer

A Phase 2 study testing trastuzumab in people with Breast Cancer and Human Epidermal Growth Factor 2 Negative Carcinoma of Breast, run by European Organisation for Research and Treatment of Cancer - EORTC at 80 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a randomized phase II trial for patients with HER2 negative primary Breast Cancer (BC) who after completing (neo) adjuvant chemotherapy and surgery have detectable circulating tumour cells (CTC) in peripheral blood. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
trastuzumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,317 participants
Where
80 sitesin 4 countries
Study dates
Apr 2013to Mar 2017
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
  • Women only
  • No healthy volunteers
  • Adult, Older adult
  • Age ≥ 18 years
  • Written informed consent must be given according to ICH/GCP, and national/local regulations
  • Availability of peripheral blood draw for CTC blood test
  • Tumor block or minimum 10 unstained slides of 4 μm of primary tumor must be available prior to registration for centralized HER2 testing
  • ER status available
  • Adequately excised non-metastatic and non-relapsed operable primary invasive HER2-negative adeno-carcinoma of the breast *:
  • the patient should have completed either
  • adjuvant chemotherapy or
  • neoadjuvant chemotherapy; in this case residual invasive disease in breast or lymph nodes is required (no complete pathological response) no further adjuvant chemotherapy treatment planned. Prior chemotherapy with doxorubicin restricted to a total dose of 360 mg/m2 or with epirubicin restricted to a total dose of 720 mg/m2 is allowed
  • No prior use of anti-HER2 therapy for any reason or immunotherapy for BC
  • No concomitant use of bisphosphonate therapy or denosumab for any reason. Prior use of these agents is allowed provided that last treatment has been received at least 4 weeks before registration in the study
  • No prior mediastinal irradiation except internal mammary node irradiation for the present BC
  • Concomitant adjuvant hormonal therapy or radiotherapy (if applicable) is allowed upon physician's choice
  • The interval between definitive surgery (neoadjuvant population) or end of adjuvant chemotherapy (adjuvant population) and registration must be at least 3 weeks but no more than 24 weeks
  • No evidence of unresolved or unstable toxicity from prior surgery, adjuvant chemotherapy or radiotherapy
  • No history of prior invasive breast carcinoma, except for the BC diagnosed and treated before entry. Unifocal or multifocal unilateral (one breast) or unifocal or multifocal synchronous bilateral breast (both breasts) cancer are acceptable if all invasive tumor foci are HER2- negative. History of previous ductal carcinoma in situ is allowed
  • No history of any malignant neoplasms in the past 5 years except for curatively treated basal and squamous cell carcinoma of the skin
  • No prior autologous or allogeneic stem cell transplantation
  • No history of serious cardiac illness or medical conditions, including but not confined to:
  • History of documented congestive heart failure
  • High risk uncontrolled arrhythmias
  • Angina pectoris requiring anti-anginal medication
  • Clinically significant valvular heart disease
  • Evidence of transmural infarction on ECG
  • Poorly controlled hypertension (e.g. systolic > 180 mm Hg or diastolic > 100 mm Hg)
  • No history of other concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions
  • Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration
  • WHO performance status 0-1
  • No concurrent participation in another trial
  • No clinically significant active infections

Trial locations and contacts

80 sites in 4 countries.

80 sites in 4 countries

Germany50 sites

  • Klinikum St. Marien

    Amberg

  • Gemeinschaftspraxis Augsburg

    Augsburg

  • Klinikum Augsburg

    Augsburg

  • Praxisklinik Krebsheilkunde für Frauen

    Berlin

  • Klinikum Sindelfingen-Boeblingen

    Böblingen

  • Medizinischen Zentrum Bonn

    Bonn

  • Marienhospital Bottrop gGmbH

    Bottrop

  • Gemeinschaftspraxis Lorenz / Hecker / Wesche

    Braunschweig

  • Onkologische-Hämatologischen Schwerpunktpraxis

    Bremen

  • Universitaetsklinikum Koeln

    Cologne

  • Onkologische Gemeinschaftspraxis

    Dresden

  • Universitaetsklinikum Carl Gustav Carus

    Dresden

  • Luisenkrankenhaus GmbH & Co. KG

    Düsseldorf

  • Universitaetsklinik Duesseldorf

    Düsseldorf

  • Universitaetsklinik Erlangen

    Erlangen

  • Universitaetsklinikum - Essen

    Essen

  • Staedtische Kliniken

    Esslingen am Neckar

  • Ev.-Luth. Diakonissenanstalt Flensburg

    Flensburg

  • Staedtische Kliniken Frankfurt Am Main-Hoechst

    Frankfurt am Main

  • Universitaetsklinikum Freiburg

    Freiburg im Breisgau

  • Universitaets-Krankenhaus Eppendorf

    Hamburg

  • Gynäkologisch-Onkologischen Schwerpunktpraxis

    Hanover

  • Medizinische Hochschule Hannover

    Hanover

  • Gemeinschaftspraxis Dr. Pourfard / Dr. Uleer

    Hildesheim

  • St. Marien-Klinik GmbH Frauenklinik der St. Vincentius-Kliniken gAG

    Karlsruhe

  • Universitaetsklinikum Schleswig-Holstein - Campus Kiel

    Kiel

  • Klinikum Landshut

    Landshut

  • Staedtisches Klinikum Leipzig - Klinikum St. Georg gGmbH

    Leipzig

  • Klinikum Ludwigsburg

    Ludwigsburg

  • Gemeinschaftspraxis Dr. Goldmann/ Dr. Ebert

    Lüneburg

  • UniversitaetsMedizin Mannheim

    Mannheim

  • Gemeinschaftspraxis Prof. Salat / Dr. Stötzer

    München

  • Ludwig-Maximilians-Universitaet Muenchen - Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe - Innenstadt

    München

  • Muencher Onkol. Praxis Elisenhof

    München

  • Klinikum Schwaebisch-Gmuend

    Mutlangen

  • Onkologische Praxis Oldenburg

    Oldenburg

  • Studienzentrum Onkologie Ravensburg

    Ravensburg

  • RoMed Klinikum Rosenheim

    Rosenheim

  • HELIOS Kliniken - HELIOS Klinik Rottweil

    Rottweil

  • HELIOS Kliniken - HELIOS Brustzentrums Nordachsen - HELIOS Klinik Schkeuditz

    Schkeuditz

  • Diakonie-Klinikum Schwäbisch Hall gGmbH

    Schwäbisch Hall

  • Leopoldina-Krankenhaus der Stadt Schweinfurt gGmbH

    Schweinfurt

  • Kliniken Landkreis Sigmaringen GmbH

    Sigmaringen

  • Klinikum Stuttgart

    Stuttgart

  • Klinikum Traunstein

    Traunstein

  • Gesellschaft für onkologische Studien, Praxismanagement und -Logistik

    Troisdorf

  • Eberhard Karls Universitaet Tuebingen - Universitaetsfrauenklinik Tuebingen

    Tübingen

  • Universitaetsklinikum Ulm

    Ulm

  • Gesundheitszentren Rhein-Neckar - GRN-Klinik Weinheim

    Weinheim

  • Onkologische Schwerpunktpraxis Wupperta

    Wuppertal

Other trials in Germany

France20 sites

  • Institut Bergonie

    Bordeaux

  • CHU de Brest

    Brest

  • Centre Regional Francois Baclesse

    Caen

  • Centre Hospitalier Alpes Léman

    Contamine-sur-Arve

  • Centre Hospitalier de la Dracénie

    Draguignan

  • CHU de Grenoble - La Tronche - Hôpital A. Michallon

    Grenoble

  • Centre Hospitalier Departemental Vendée

    La Roche-sur-Yon

  • Centre Hospitalier de Versailles - Hopital Andre Mignot

    Le Chesnay

  • CHU de Limoges - Hopital Dupuytren

    Limoges

  • Clinique de la Sauvegarde

    Lyon

  • Centre Hospitalier D'Annecy

    Metz-Tessy

  • Centre Hospitalier de Mont-de-Marsan

    Mont-de-Marsan

  • Centre Catherine De Sienne

    Nantes

  • Institut Curie

    Paris

  • Institut Curie - Hopital Rene Huguenin

    Saint-Cloud

  • Hopitaux Universitaires de Strasbourg - Hôpitaux Universitaires de Strasbourg - Hôpital civil

    Strasbourg

  • Hopitaux du Leman - Site Georges Pianta

    Thonon-les-Bains

  • CH de Valence

    Valence

  • Institut de Cancérologie de Lorraine

    Vandœuvre-lès-Nancy

  • Gustave Roussy

    Villejuif

Other trials in France

Belgium9 sites

  • Onze Lieve Vrouw Ziekenhuis

    Aalst

  • Hopital Universitaire Brugmann

    Brussels

  • Hopitaux Universitaires Bordet-Erasme - Hopital Universitaire Erasme

    Brussels

  • Hôpitaux Universitaires Bordet-Erasme - Institut Jules Bordet

    Brussels

  • Hopital De Jolimont

    Haine-Saint-Paul

  • U.Z. Leuven - Campus Gasthuisberg

    Leuven

  • C.H.U. Sart-Tilman

    Liège

  • Clinique et Maternité Sainte Elisabeth

    Namur

  • AZ Damiaan

    Ostend

Other trials in Belgium

United Kingdom1 site

  • Oxford University Hospitals NHS Trust - Churchill Hospital

    Oxford

Other trials in United Kingdom

About this study

Official title: TRastuzumab in HER2-negative Early Breast Cancer as Adjuvant Treatment for Circulating Tumor Cells (CTC) ("TREAT CTC" Trial)

This is a randomized phase II trial for patients with HER2 negative primary Breast Cancer (BC) who after completing (neo) adjuvant chemotherapy and surgery have detectable circulating tumour cells (CTC) in peripheral blood.

Eligible patients will be randomised in 1:1 ratio to either the trastuzumab arm or the observation arm.

Read the detailed description

This is a randomized phase II trial for patients with HER2 negative primary BC who after completing (neo) adjuvant chemotherapy and surgery have detectable CTC(s) in peripheral blood (see eligibility criteria for details). Eligible patients will be randomized in 1:1 ratio to either the trastuzumab arm or the observation arm. Patients randomized to the trastuzumab arm will receive a total of 6 intravenous (IV) administrations every 3 weeks (loading dose 8 mg/kg IV and 5 cycles at 6 mg/kg every 3 weeks). Patients randomized to observation arm shall be observed for 18 weeks. Left ventricular ejection fraction (LVEF) assessment (MUGA and/or ECHO) will be done at baseline for all patients to be randomized. The next LVEF assessments of weeks 9 and week 18 will be done only in patients randomized to trastuzumab arm. Patient registered but with CTC negative result will not be followed-up.

Being tested
trastuzumab
Keywords
Circulating Tumour Cells, HER2 negative primary breast cancer, HER2 positive CTC, Trastuzumab
Medical subject headings
Breast Neoplasms, Neoplastic Cells, Circulating

What participants receive

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

  • trastuzumabDrug

    Also called endocrine therapy, anti HER2 therapy

    8 mg/kg of loading dose IV over 90 minutes for the first cycle, followed by 6 mg/kg IV over 60 minutes every 3 weeks for the 5 subsequent cycles.

Study groups in NCT01548677
Study groupRoleWhat they receive
observationNo intervention18 weeks
Herceptin (trastuzumab)Experimental18 weeks
Receives: Drug: trastuzumab

What is being measured

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

  1. CTC detection

    To compare circulating tumour cell (CTC)detection rate at week 18 between trastuzumab treatment arm and observational arm.

    Measured: 18 weeks post randomisation

Secondary outcomes (7)

  1. RFI (recurrence free interval)

    Recurrence Free Interval (RFI) (key secondary endpoint) between trastuzumab and observation

    Measured: 2 years after LPI (last patient in)

  2. IDFS (Invasive Disease Free Survival)

    Invasive Disease Free Survival between trastuzumab and observation

    Measured: 2 years after LPI

  3. DFS (disease free survival)

    Disease Free survival between trastuzumab and observation

    Measured: 2 years after LPI

  4. OS (overall survival)

    Overall Survival between trastuzumab and observation

    Measured: 2 years after LPI

  5. CTC essay

    To evaluate in a clinical trial setting the feasibility, reliability, within patient reproducibility and variability of the assay for CTC(s)

    Measured: 2 years after LPI

  6. CTC correlation

    To correlate CTC detection rate at baseline and/or week 18 with RFI, IDFS, DFS, OS

    Measured: 2 years after LPI

  7. safety (cardiac)

    To assess safety, especially cardiac safety, of trastuzumab in women with HER2 negative primary tumors and CTC

    Measured: 2 years after LPI

Timeline

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

  1. First posted8 Mar 2012 (estimated)
  2. Study startApr 2013
  3. Primary completionMar 2017
  4. Study completionMar 2017

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,317 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01548677
Sponsor's protocol ID
EORTC-90091-10093
Other IDs
2009-017485-23, 2009
Acronym
TREAT-CTC
Status last verified
Mar 2019
First submitted
5 Mar 2012
Last updated
13 Mar 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • Ignatiadis M, Rack B, Rothe F, Riethdorf S, Decraene C, Bonnefoi H, Dittrich C, Messina C, Beauvois M, Trapp E, Goulioti T, Tryfonidis K, Pantel K, Repollet M, Janni W, Piccart M, Sotiriou C, Litiere S, Pierga JY. Liquid biopsy-based clinical research in early breast cancer: The EORTC 90091-10093 Treat CTC trial. Eur J Cancer. 2016 Aug;63:97-104. doi: 10.1016/j.ejca.2016.04.024. Epub 2016 Jun 10.

    PubMed 27289552

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing trastuzumab in people with Breast Cancer and Human Epidermal Growth Factor 2 Negative Carcinoma of Breast, run by European Organisation for Research and Treatment of Cancer - EORTC at 80 sites in 4 countries.

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

Who may be eligible to take part?

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: finished, as of the sponsor's last update on 13 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 80 sites in Germany, France, Belgium, United Kingdom. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

CTC detection (time frame: 18 weeks post randomisation). 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 NCT01548677, 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 13 Mar 2019.

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