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Randomized Trial With Trastuzumab Versus Observation in Breast Cancer Patients

This study has been completed.
Sponsor:
Information provided by:
University Hospital of Crete
ClinicalTrials.gov Identifier:
NCT00429247
First received: January 30, 2007
Last updated: July 20, 2011
Last verified: January 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Breast Cancer
 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: 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

Resource links provided by NLM:

Drug Information available for: Trastuzumab
U.S. FDA Resources

Further study details as provided by University Hospital of Crete:

Primary Outcome Measures:
  • Compare the disease-free interval of patients with early-stage breast cancer [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Elimination of CK-19 mRNA-positive CTCs. [ Time Frame: Assessment of CK-19 mRNA CTCs every 3 months ] [ Designated as safety issue: No ]

Enrollment: 75
Study Start Date: February 2003
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Her
 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
No Intervention: 2
Follow up

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00429247

Locations
Greece
University Hospital of Crete
Heraklion, Crete, Greece, 71110
Sponsors and Collaborators
University Hospital of Crete
Investigators
Principal Investigator: Vassilis Georgoulias, MD University Hospital of Crete, Dep of Medical Oncology
  More Information

No publications provided

Responsible Party: V.Georgoulias, University Hospital of Crete
ClinicalTrials.gov Identifier: NCT00429247     History of Changes
Other Study ID Numbers: CT/01.60
Study First Received: January 30, 2007
Last Updated: July 20, 2011
Health Authority: Greece: National Organization of Medicines

Keywords provided by University Hospital of Crete:
Occult tumor cells
Micrometastatic cells
Cytokeratin-19
Trastuzumab
Completion of Adjuvant Treatment

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
 Trastuzumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013