- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00429247
Randomized Trial With Trastuzumab Versus Observation in Breast Cancer Patients
July 20, 2011 updated by: University Hospital of Crete
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
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
75
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Crete
-
Heraklion, Crete, Greece, 71110
- University Hospital of Crete
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 1
Her
|
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 Names:
|
NO_INTERVENTION: 2
Follow up
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Compare the disease-free interval of patients with early-stage breast cancer
Time Frame: 3 years
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Elimination of CK-19 mRNA-positive CTCs.
Time Frame: Assessment of CK-19 mRNA CTCs every 3 months
|
Assessment of CK-19 mRNA CTCs every 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2003
Primary Completion (ACTUAL)
December 1, 2007
Study Completion (ACTUAL)
December 1, 2007
Study Registration Dates
First Submitted
January 30, 2007
First Submitted That Met QC Criteria
January 30, 2007
First Posted (ESTIMATE)
January 31, 2007
Study Record Updates
Last Update Posted (ESTIMATE)
July 21, 2011
Last Update Submitted That Met QC Criteria
July 20, 2011
Last Verified
January 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CT/01.60
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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