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Completed

NCT Number: NCT00429247

Randomized Trial With Trastuzumab Versus Observation in Breast Cancer Patients

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

University Hospital of Crete

Heraklion, Crete, 71110, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Trastuzumab

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

Other names: Herceptin

Primary outcomes

  1. Compare the disease-free interval of patients with early-stage breast cancer

    Time frame: 3 years

Secondary outcomes

  1. Elimination of CK-19 mRNA-positive CTCs.

    Time frame: Assessment of CK-19 mRNA CTCs every 3 months

Sponsors and collaborators

Lead sponsor

University Hospital of Crete

Other

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2007
Study completion
2007
First posted
Jan 31, 2007
Registry last updated
Jul 21, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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