Randomized Trial With Trastuzumab Versus Observation in Breast Cancer Patients

University Hospital of Crete

Status and phase

Completed

Phase 2

Conditions

Breast Cancer

Treatments

Drug: Trastuzumab

Study type

Interventional

Funder types

Other

Identifiers

NCT00429247

CT/01.60

Details and patient eligibility

About

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.

Full 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.

Enrollment

75 patients

Sex

Female

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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)