Randomized Trial With Trastuzumab Versus Observation in Breast Cancer Patients

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. Identifier: NCT00429247
Recruitment Status : Completed
First Posted : January 31, 2007
Last Update Posted : July 21, 2011
Information provided by:
University Hospital of Crete

January 30, 2007
January 31, 2007
July 21, 2011
February 2003
December 2007   (Final data collection date for primary outcome measure)
Compare the disease-free interval of patients with early-stage breast cancer [ Time Frame: 3 years ]
  • Compare the disease-free interval of patients with early-stage breast cancer
  • with detectable CK-19 mRNA-positive DTCs or/and CTCs before or/and after
  • the completion of adjuvant chemotherapy and radiotherapy
  • who received or not “secondary adjuvant treatment” with trastuzumab (HERCEPTIN)
Complete list of historical versions of study NCT00429247 on Archive Site
Elimination of CK-19 mRNA-positive CTCs. [ Time Frame: Assessment of CK-19 mRNA CTCs every 3 months ]
Determine the effect of trastuzumab (HERCEPTIN) on the CK-19 mRNA-positive CTCs
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Randomized Trial With Trastuzumab Versus Observation in Breast Cancer Patients
A Pilot Randomized Phase II Study of Adjuvant Administration of Trastuzumab (HERCEPTIN) Versus Observation After the Completion of Adjuvant Chemotherapy and Radiotherapy in Patients With Stage I-III Breast Cancer Who Have Detectable Disseminated and/or Circulating Tumor Cells (DTCs and/or CTCs) in the Bone Marrow or/and the Peripheral Blood Before or/and After the Completion of Adjuvant Treatment
Epithelial tumor cells can be detected in the bone marrow and/or the peripheral blood [disseminated and circulating tumor cells, (DTCs) and (CTCs) respectively] of otherwise metastases-free patients with early breast cancer. Several studies have shown that the presence of these cells is an independent factor associated with an increased incidence of early disease relapse and disease-related death. In almost 50% of the patients, adjuvant chemotherapy cannot eliminate these occult tumor cells and this is also associated with a higher probability of early relapse and death. In 60-70% of the patients, DTCs and/or CTCs express the HER2/c-neu molecule and one or two administrations of their monoclonal antibody trastuzumab (HERCEPTIN) could eliminate these cells for a period ranging from 3-12 months.
This pilot trial will compare the efficacy of the anti-HER2/erb-B2 monoclonal antibody trastuzumab (HERCEPTIN) given after the completion of the standard adjuvant chemotherapy and radiotherapy versus observation in patients with stage I-III operable breast cancer who have detectable cytokeratin-19 (CK-19) mRNA-positive tumor cells in the bone marrow or the peripheral blood before and/or after the adjuvant treatment.
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Breast Cancer
Drug: Trastuzumab
Trastuzumab,first administration at the dose of 8mg/Kg IV, subsequent administrations at the dose of 6mg/Kg IV,every 3 weeks for 6 cycles
Other Name: Herceptin
  • Experimental: 1
    Intervention: Drug: Trastuzumab
  • No Intervention: 2
    Follow up
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2007
December 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age >= 18 years.
  • Performance status (World Health Organization [WHO]) < 3
  • Adequate bone marrow function (absolute neutrophil count > 1000/mm^3, platelet count > 100000/mm^3, hemoglobin > 9 gr/mm^3)
  • Adequate liver (bilirubin < 1.5 times upper limit of normal and SGOT/SGPT < 2 times upper limit of normal) and renal function ( creatinine < 2 mg/dl)
  • Adequate cardiac function (left ventricular ejection fraction [LVEF] > 50%).
  • Informed consent
  • Histologically or cytologically confirmed breast adenocarcinoma
  • Prior surgical excision of the primary breast tumor
  • Prior completion of standard adjuvant chemotherapy and/or radiotherapy
  • Locally advanced disease after the completion of neo-adjuvant chemotherapy, surgical excision and radiotherapy provided that there was no evidence of local or metastatic disease
  • Absence of any clinical or laboratory evidence of metastatic disease
  • Detection of CTCs and/or DTCs (when it could be feasible) before the initiation and/or after the completion of adjuvant chemotherapy and/or radiotherapy
  • Expression of HER2/c-neu on the primary tumor is not mandatory

Exclusion Criteria:

  • Other invasive malignancy within the past 5 years except nonmelanoma skin cancer
  • Other concurrent uncontrolled illness
  • Psychiatric illness or social situation that would preclude study compliance
  • Pregnant or nursing
  • Positive pregnancy test
  • History of allergic reaction attributed to trastuzumab (HERCEPTIN)
Sexes Eligible for Study: Female
18 Years to 75 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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V.Georgoulias, University Hospital of Crete
University Hospital of Crete
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Principal Investigator: Vassilis Georgoulias, MD University Hospital of Crete, Dep of Medical Oncology
University Hospital of Crete
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP