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

March 12, 2019 updated by: European Organisation for Research and Treatment of Cancer - EORTC

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1317

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Aalst, Belgium
        • Onze Lieve Vrouw Ziekenhuis
      • Brussels, Belgium
        • Hopitaux Universitaires Bordet-Erasme - Institut Jules Bordet
      • Brussels, Belgium
        • Hopitaux Universitaires Bordet-Erasme - Hopital Universitaire Erasme
      • Brussels, Belgium
        • Hopital Universitaire Brugmann
      • Haine St Paul, Belgium
        • Hopital De Jolimont
      • Leuven, Belgium
        • U.Z. Leuven - Campus Gasthuisberg
      • Liege, Belgium
        • C.H.U. Sart-Tilman
      • Namur, Belgium
        • Clinique et Maternite Sainte Elisabeth
      • Oostende, Belgium
        • AZ Damiaan
  • France
      • Bordeaux, France
        • Institut Bergonie
      • Brest, France
        • CHU de Brest
      • Caen, France
        • Centre Regional Francois Baclesse
      • Contamine sur Arve, France
        • Centre Hospitalier Alpes Leman
      • Draguignan, France
        • Centre Hospitalier de la Dracénie
      • Grenoble, France
        • CHU de Grenoble - La Tronche - Hôpital A. Michallon
      • La Roche Sur Yon, France
        • Centre Hospitalier Departemental Vendee
      • Le Chesnay, France
        • Centre Hospitalier de Versailles - Hopital Andre Mignot
      • Limoges, France
        • CHU de Limoges - Hopital Dupuytren
      • Lyon, France
        • Clinique de la Sauvegarde
      • Metz-Tessy, France
        • Centre hospitalier d'Annecy
      • Mont-de-Marsan, France
        • Centre Hospitalier de Mont-de-Marsan
      • Nantes, France
        • Centre Catherine de Sienne
      • Paris, France
        • Institut Curie
      • Saint-Cloud, France
        • Institut Curie - Hopital Rene Huguenin
      • Strasbourg, France
        • Hopitaux Universitaires de Strasbourg - Hôpitaux Universitaires de Strasbourg - Hôpital civil
      • Thonon les Bains, France
        • Hopitaux Du Leman - Site Georges Pianta
      • Valence, France
        • CH de Valence
      • Vandoeuvre-Les-Nancy, France
        • Institut de Cancérologie de Lorraine
      • Villejuif, France
        • Gustave Roussy
  • Germany
      • Amberg, Germany
        • Klinikum St. Marien
      • Augsburg, Germany
        • Klinikum Augsburg
      • Augsburg, Germany
        • Gemeinschaftspraxis Augsburg
      • Berlin, Germany
        • Praxisklinik Krebsheilkunde für Frauen
      • Boeblingen, Germany
        • Klinikum Sindelfingen-Boeblingen
      • Bonn, Germany
        • Medizinischen Zentrum Bonn
      • Bottrop, Germany
        • Marienhospital Bottrop gGmbH
      • Braunschweig, Germany
        • Gemeinschaftspraxis Lorenz / Hecker / Wesche
      • Bremen, Germany
        • Onkologische-Hämatologischen Schwerpunktpraxis
      • Dresden, Germany
        • Universitaetsklinikum Carl Gustav Carus
      • Dresden, Germany
        • Onkologische Gemeinschaftspraxis
      • Duesseldorf, Germany
        • Luisenkrankenhaus GmbH & Co. KG
      • Duesseldorf, Germany
        • Universitaetsklinik Duesseldorf
      • Erlangen, Germany
        • Universitaetsklinik Erlangen
      • Essen, Germany
        • Universitaetsklinikum - Essen
      • Esslingen, Germany
        • Staedtische Kliniken
      • Flensburg, Germany
        • Ev.-Luth. Diakonissenanstalt Flensburg
      • Frankfurt Am Main, Germany
        • Staedtische Kliniken Frankfurt Am Main-Hoechst
      • Freiburg, Germany
        • Universitaetsklinikum Freiburg
      • Hamburg, Germany
        • Universitaets-Krankenhaus Eppendorf
      • Hannover, Germany
        • Medizinische Hochschule Hannover
      • Hannover, Germany
        • Gynäkologisch-Onkologischen Schwerpunktpraxis
      • Hildesheim, Germany
        • Gemeinschaftspraxis Dr. Pourfard / Dr. Uleer
      • Karlsruhe, Germany
        • St. Marien-Klinik GmbH Frauenklinik der St. Vincentius-Kliniken gAG
      • Kiel, Germany
        • Universitaetsklinikum Schleswig-Holstein - Campus Kiel
      • Koeln, Germany
        • Universitaetsklinikum Koeln
      • Landshut, Germany
        • Klinikum Landshut
      • Leipzig, Germany
        • Staedtisches Klinikum Leipzig - Klinikum St. Georg gGmbH
      • Ludwigsburg, Germany
        • Klinikum Ludwigsburg
      • Lueneburg, Germany
        • Gemeinschaftspraxis Dr. Goldmann/ Dr. Ebert
      • Mannheim, Germany
        • Universitaetsmedizin Mannheim
      • Muenchen, Germany
        • Gemeinschaftspraxis Prof. Salat / Dr. Stötzer
      • Muenchen, Germany
        • Ludwig-Maximilians-Universitaet Muenchen - Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe - Innenstadt
      • Muenchen, Germany
        • Muencher Onkol. Praxis Elisenhof
      • Mutlangen, Germany
        • Klinikum Schwaebisch-Gmuend
      • Oldenburg, Germany
        • Onkologische Praxis Oldenburg
      • Ravensburg, Germany
        • Studienzentrum Onkologie Ravensburg
      • Rosenheim, Germany
        • RoMed Klinikum Rosenheim
      • Rottweil, Germany
        • HELIOS Kliniken - HELIOS Klinik Rottweil
      • Schkeuditz, Germany
        • HELIOS Kliniken - HELIOS Brustzentrums Nordachsen - HELIOS Klinik Schkeuditz
      • Schwaebisch Hall, Germany
        • Diakonie-Klinikum Schwäbisch Hall gGmbH
      • Schweinfurt, Germany
        • Leopoldina-Krankenhaus der Stadt Schweinfurt gGmbH
      • Sigmaringen, Germany
        • Kliniken Landkreis Sigmaringen GmbH
      • Stuttgart, Germany
        • Klinikum Stuttgart
      • Traunstein, Germany
        • Klinikum Traunstein
      • Troisdorf, Germany
        • Gesellschaft für onkologische Studien, Praxismanagement und -Logistik
      • Tuebingen, Germany
        • Eberhard Karls Universitaet Tuebingen - Universitaetsfrauenklinik Tuebingen
      • Ulm, Germany
        • Universitaetsklinikum Ulm
      • Weinheim, Germany
        • Gesundheitszentren Rhein-Neckar - GRN-Klinik Weinheim
      • Wuppertal, Germany
        • Onkologische Schwerpunktpraxis Wupperta
  • United Kingdom
      • Oxford, United Kingdom
        • Oxford University Hospitals NHS Trust - Churchill Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: observation
18 weeks
Experimental: Herceptin (trastuzumab)
18 weeks
Drug: trastuzumab
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.
Other Names:
  • endocrine therapy
  • anti HER2 therapy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
CTC detection
Time Frame: 18 weeks post randomisation
To compare circulating tumour cell (CTC)detection rate at week 18 between trastuzumab treatment arm and observational arm.
18 weeks post randomisation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
RFI (recurrence free interval)
Time Frame: 2 years after LPI (last patient in)
Recurrence Free Interval (RFI) (key secondary endpoint) between trastuzumab and observation
2 years after LPI (last patient in)
IDFS (Invasive Disease Free Survival)
Time Frame: 2 years after LPI
Invasive Disease Free Survival between trastuzumab and observation
2 years after LPI
DFS (disease free survival)
Time Frame: 2 years after LPI
Disease Free survival between trastuzumab and observation
2 years after LPI
OS (overall survival)
Time Frame: 2 years after LPI
Overall Survival between trastuzumab and observation
2 years after LPI
CTC essay
Time Frame: 2 years after LPI
To evaluate in a clinical trial setting the feasibility, reliability, within patient reproducibility and variability of the assay for CTC(s)
2 years after LPI
CTC correlation
Time Frame: 2 years after LPI
To correlate CTC detection rate at baseline and/or week 18 with RFI, IDFS, DFS, OS
2 years after LPI
safety (cardiac)
Time Frame: 2 years after LPI
To assess safety, especially cardiac safety, of trastuzumab in women with HER2 negative primary tumors and CTC
2 years after LPI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
European Organisation for Research and Treatment of Cancer - EORTC

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hoffmann-La Roche
UNICANCER
Janssen Diagnostics, LLC
SUCCESS

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michail Ignatiadis, MD, Institut Jules Bordet, Brussels, Belgium
  • Study Chair: Martine Piccart, MD, Institut Jules Bordet, Brussels, Belgium
  • Study Chair: Christos Sotiriou, MD, Institut Jules Bordet, Brussels, Belgium
  • Study Chair: Jean-Yves Pierga, MD, Institut Curie, Paris, France
  • Study Chair: Brigitte Rack, MD, Ludwig-Maximilians-Universitaet Muenchen - Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe - Innenstadt, Munich, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 5, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 8, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 13, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EORTC-90091-10093
  • 2009-017485-23 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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