Status:
UNKNOWN
Efficacy Study of Single Agent Trastuzumab or Lapatinib to Treat HER2-Overexpressing Breast Cancer
Lead Sponsor:
Azienda Ospedaliera Ordine Mauriziano di Torino
Conditions:
Metastatic Breast Cancer
Eligibility:
FEMALE
18-75 years
Phase:
PHASE2
Brief Summary
This study will evaluate the activity of single agent trastuzumab or lapatinib in patients not previously treated for HER-2 positive (FISH positive) metastatic breast cancer. A companion biological st...
Eligibility Criteria
Inclusion
- Women aged 18-75 years
- Histologically or cytologically confirmed metastatic disease.
- HER2-Overexpression proven by Fluorescence in Situ Hybridization (FISH).
- Availability of paraffin-embedded block of either primitive tumor and/or biopsy of metastases.
- No prior chemotherapy for metastatic or locally advanced disease. Patients with hormone receptor (oestrogen and/or progesterone) positive breast cancer can be eligible provided that they had received only ONE line of hormonal therapy for metastatic disease.
- For patients undergoing hormonal therapy for metastatic disease, disease progression must be confirmed according to RECIST criteria.
- At least 20% increase in the sum of longest diameters, OR
- Evidence of new metastatic lesions or progression of pre-existing non-target lesions.
- Presence of at least one monodimensionally measurable lesion. Patients without clinically or radiologically proven evidence of disease are not eligible.
- Patients with exclusively skin disease are eligible, provided that the disease evolution under treatment can be photographically documented.
- Patients with involvement of NCS, besides presence of measurable lesions, are eligible provided that:
- Brain lesion/s has/have been radically resected;
- Brain lesion/s has/have obtained complete remission following radiation therapy. Complete remission must be documented by TC or RMN.
- At least 4-week interval from end of radiotherapy, hormono- or immunotherapy and enrollment in this study.
- ECOG PS \</= 2 and life expectancy of at least 6 months.
- Liver metastases involving \< 30% of liver volume.
- Adequate hematopoietic, liver and renal function
- Written informed consent.
- Patients with childbearing potential must have negative pregnancy test and must use adequate contraceptive measures during treatment.
- Prior treatment with Trastuzumab as adjuvant therapy is permitted provided that it was completed at least 12 months prior enrollment in this study.
Exclusion
- Prior chemotherapy for metastatic disease.
- Active pregnancy or breastfeeding.
- Previous treatment with Lapatinib.
- Previous therapy with mono- or policlonal antibodies for metastatic disease.
- Patients with bone involvement or pleural effusion/ascites as unique localization of disease.
- Patients with dyspnea due to presence of disease (lymphangitis) or requiring oxygen therapy.
- Patients with clinically evident hearth disease and/or active infectious diseases.
- Patients with not resected or not irradiated brain and/or leptomeningeal metastases.
- Prior or actual concurrent neoplasms, with the exception of adequately treated carcinoma della cervice uterina and basal cell or squamocellular carcinoma of the skin.
- Patients with uncontrolled serious illnesses that may compromise the compliance of the patient to the treatment.
- Previous allergic reactions towards any excipient in the composition of Trastuzumab or Lapatinib.
- Use of any experimental drug within 4 weeks prior initiation of study treatment.
- Women with childbearing potential who refuse to use adequate contraceptive measures.
- Patients unable to give written informed consent or are not compliant with treatment.
- Patients with great tumor involvement (\> 30% dof hepatic volume, etc).
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2011
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00842998
Start Date
February 1 2009
End Date
December 1 2011
Last Update
June 26 2009
Active Locations (4)
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1
U.O. Oncologia Medica - Ospedale San Luigi
Orbassano, Torino, Italy, 10043
2
Institute for Cancer Research and Treatment (I.R.C.C.)
Candiolo , Torino, Italy, 10060
3
U.O. Oncologia Medica
Cuneo, Italy, 12100
4
U.O. Oncologia Medica - COES Molinette
Torino, Italy, 10126