Trial record 19 of 2064 for:    breast,cancer,treatment | Open Studies

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by European Organisation for Research and Treatment of Cancer - EORTC
Sponsor:
Collaborators:
Hoffmann-La Roche
Janssen Diagnostics, LLC
SUCCESS
UNICANCER
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT01548677
First received: March 5, 2012
Last updated: July 11, 2016
Last verified: July 2016
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
Circulating Tumor Cells
Drug: trastuzumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: TRastuzumab in HER2-negative Early Breast Cancer as Adjuvant Treatment for Circulating Tumor Cells (CTC) ("TREAT CTC" Trial)

Resource links provided by NLM:


Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:

Primary Outcome Measures:
  • CTC detection [ Time Frame: 18 weeks post randomisation ] [ Designated as safety issue: No ]
    To compare circulating tumour cell (CTC)detection rate at week 18 between trastuzumab treatment arm and observational arm.


Secondary Outcome Measures:
  • RFI (recurrence free interval) [ Time Frame: 2 years after LPI (last patient in) ] [ Designated as safety issue: No ]
    Recurrence Free Interval (RFI) (key secondary endpoint) between trastuzumab and observation

  • IDFS (Invasive Disease Free Survival) [ Time Frame: 2 years after LPI ] [ Designated as safety issue: No ]
    Invasive Disease Free Survival between trastuzumab and observation

  • DFS (disease free survival) [ Time Frame: 2 years after LPI ] [ Designated as safety issue: No ]
    Disease Free survival between trastuzumab and observation

  • OS (overall survival) [ Time Frame: 2 years after LPI ] [ Designated as safety issue: No ]
    Overall Survival between trastuzumab and observation

  • CTC essay [ Time Frame: 2 years after LPI ] [ Designated as safety issue: No ]
    To evaluate in a clinical trial setting the feasibility, reliability, within patient reproducibility and variability of the assay for CTC(s)

  • CTC correlation [ Time Frame: 2 years after LPI ] [ Designated as safety issue: No ]
    To correlate CTC detection rate at baseline and/or week 18 with RFI, IDFS, DFS, OS

  • safety (cardiac) [ Time Frame: 2 years after LPI ] [ Designated as safety issue: Yes ]
    To assess safety, especially cardiac safety, of trastuzumab in women with HER2 negative primary tumors and CTC


Estimated Enrollment: 2175
Study Start Date: April 2013
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01548677

Contacts
Contact: Mélanie Beauvois, PhD +32 27741687 melanie.beauvois@eortc.be

  Show 80 Study Locations
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Hoffmann-La Roche
Janssen Diagnostics, LLC
SUCCESS
UNICANCER
Investigators
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
  More Information

Additional Information:
Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT01548677     History of Changes
Other Study ID Numbers: EORTC-90091-10093  2009-017485-23 
Study First Received: March 5, 2012
Last Updated: July 11, 2016
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Greece: National Organization of Medicines
Germany: Federal Institute for Drugs and Medical Devices
Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
Circulating Tumour Cells
HER2 negative primary breast cancer
HER2 positive CTC
Trastuzumab

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Neoplasm Metastasis
Neoplastic Cells, Circulating
Skin Diseases
Neoplastic Processes
Pathologic Processes
Trastuzumab
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 30, 2016