Randomized Trial With Trastuzumab Versus Observation in Breast Cancer Patients

NCT ID: NCT00429247

Last Updated: 2011-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-02-28
• Study Completion Date: 2007-12-31

Brief 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.

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Her

Group Type: EXPERIMENTAL

Trastuzumab

Intervention Type: DRUG

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

2

Follow up

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: DRUG

Other Intervention Names

Herceptin

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital of Crete

OTHER

Sponsor Role: lead

Responsible Party

University Hospital of Crete

Principal Investigators

Vassilis Georgoulias, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Crete, Dep of Medical Oncology

Locations

University Hospital of Crete

Heraklion, Crete, Greece

Countries

Greece

Other Identifiers

CT/01.60

Identifier Type: -

Identifier Source: org_study_id