Randomized Trial With Trastuzumab Versus Observation in Breast Cancer Patients
Information source: University Hospital of Crete
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breast Cancer
Intervention: Trastuzumab (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: University Hospital of Crete Official(s) and/or principal investigator(s): Vassilis Georgoulias, MD, Principal Investigator, Affiliation: University Hospital of Crete, Dep of Medical Oncology
Summary
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Compare the disease-free interval of patients with early-stage breast cancer
Secondary outcome: Elimination of CK-19 mRNA-positive CTCs.
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
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Female.
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)
Locations and Contacts
University Hospital of Crete, Heraklion, Crete 71110, Greece
Additional Information
Starting date: February 2003
Last updated: July 20, 2011
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