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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01548677
Recruitment Status : Active, not recruiting
First Posted : March 8, 2012
Last Update Posted : October 26, 2016
Information provided by (Responsible Party):

Study Description
Brief 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.

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

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

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2175 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Study Start Date : April 2013
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Trastuzumab
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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. IDFS (Invasive Disease Free Survival) [ Time Frame: 2 years after LPI ]
    Invasive Disease Free Survival between trastuzumab and observation

  3. DFS (disease free survival) [ Time Frame: 2 years after LPI ]
    Disease Free survival between trastuzumab and observation

  4. OS (overall survival) [ Time Frame: 2 years after LPI ]
    Overall Survival between trastuzumab and observation

  5. 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)

  6. CTC correlation [ Time Frame: 2 years after LPI ]
    To correlate CTC detection rate at baseline and/or week 18 with RFI, IDFS, DFS, OS

  7. 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

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01548677

  Show 80 Study Locations
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Hoffmann-La Roche
Janssen Diagnostics, LLC
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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 ( EudraCT Number )
First Posted: March 8, 2012    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016

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

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