Patient case: 35-year-old female with Breast cancer. Genetic variant: NRAS Amplification. Other conditions: None.

Clinical trial: Efficacy Study of Single Agent Trastuzumab or Lapatinib to Treat HER2-Overexpressing Breast Cancer

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 study will assess factors correlated with sensitivity or resistance to either one of the compounds


Eligibility: Inclusion Criteria:
  -  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 Criteria:
  -  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).

Relevance to patient case: not relevant