Trial record 13 of 1678 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 December 2013 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: December 9, 2013
Last verified: December 2013
  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: April 2017
Estimated Primary Completion Date: April 2015 (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
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female gender
  • WHO performance status 0-1
  • Non-metastatic and non-relapsed operable primary invasive HER2 negative adeno-carcinoma of the breast that is adequately excised and all of the following:

    • histological grade > 1 at the time of surgery (all patients) and primary tumor size > 1 cm
    • the patient should have completed either
    • adjuvant chemotherapy for node-positive disease (pN ≥1, macrometastasis only) or
    • neoadjuvant chemotherapy. In this case, no pathological complete response (defined as any residual invasive disease in breast or lymph nodes) after neoadjuvant chemotherapy is required.
  • Availability of peripheral blood draw for CTC blood test
  • Tumor block or unstained slides of primary tumor must be available prior to randomization for centralized HER2 testing
  • 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.
  • Adjuvant hormonal therapy or adjuvant radiotherapy (if applicable) is allowed upon physician's choice
  • The interval between definitive surgery (neoadjuvant group) or end of adjuvant chemotherapy (adjuvant group) and registration must be at least 3 weeks but no more than 12 weeks.

Exclusion Criteria:

  • No further adjuvant chemotherapy treatment planned.
  • No prior use of anti-HER2 therapy for any reason or other prior use of biological agent or immunotherapy for BC
  • No prior and/or concomitant use of bisphosphonate therapy for any reason is allowed.
  • No prior mediastinal irradiation except internal mammary node irradiation for the present BC
  • No history of prior (ipsilateral and/or contralateral) invasive breast carcinoma or ductal carcinoma in situ.
  • No history of any malignant neoplasms in the past 5 years except for curatively treated basal and squamous cell carcinoma of the skin.
  • No history of serious cardiac illness or other concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions. Baseline LVEF≥55% measured by echocardiography or MUGA scan (performed 2 weeks before randomization)

Eligibility Criteria at patient randomisation:

  • ≥1CTC/15mL of blood by CellSearch® between 3 weeks and up to 12 weeks after surgery (neoadjuvant population) or end of adjuvant chemotherapy (adjuvant population).
  • Centrally confirmed HER2-negative primary BC. Centralized HER2 testing will be performed in the surgical tumor specimen. A HER2-negative primary BC sample eligible for randomization should have HER2 IHC scores of 0 or 1+ or 2+ AND should be HER2 FISH negative in central testing.
  • Baseline LVEF≥55% measured by echocardiography or MUGA scan (performed within 2 weeks prior to randomization)
  • No evidence of unresolved or unstable serious toxicity from prior surgery, adjuvant chemotherapy or radiotherapy
  • No concurrent participation in another trial.
  • Written informed consent must be given according to ICH/GCP, and national/local regulations
  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
Contact: Carlo GM Messina, MD MPhil +32 2 7741518 carlo.messina@eortc.be

Locations
Belgium
Onze Lieve Vrouw Ziekenhuis Recruiting
Aalst, Belgium
Hôpitaux Universitaires Bordet-Erasme - Institut Jules Bordet Recruiting
Brussels, Belgium
Hopital Universitaire Brugmann Recruiting
Brussels, Belgium
C.H.U. Sart-Tilman Recruiting
Liege, Belgium
Clinique et Maternité Sainte Elisabeth Recruiting
Namur, Belgium
AZ Damiaan Recruiting
Oostende, Belgium
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:
No publications provided

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: December 9, 2013
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
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasm Metastasis
Carcinoma
Neoplastic Cells, Circulating
Skin Diseases
Neoplastic Processes
Pathologic Processes
Trastuzumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014