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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

Page last updated: August 23, 2015

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