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

Clinical trial: Neoadjuvant Trastuzumab and Letrozole for Postmenopausal Women

Summary: The purpose of this study is to evaluate whether trastuzumab and letrozole are effective and safe in the preoperative treatment for postmenopausal patients with hormone receptor-positive and HER2-positive breast cancer.

Detailed description: Eligibility criteria
  -  Ages Eligible for Study: ≥ 20 years
  -  Invasive cancer (clinical stage IB-IIIB)
  -  Measurable tumor larger than 1cm
  -  ECOG status 0 or 1
  -  Postmenopausal women
  -  Age ≥55 years and amenorrhea
  -  Age <55 years and amenorrhea for ≥12 months with FSH >30 mIU/ml
  -  HER2 positive tumor
  -  3 positive on IHC
  -  2 positive on IHC with HER2 gene amplification on FISH or SISH using a single-probe or dual-probe
  -  Estrogen receptor positive tumor
  -  Positive ER expression with Allred score more than PS3/TS8 or modified Allred score more than PS4/TS7
  -  Eligible cardiac function
  -  Normal heard evaluated by ECG
  -  Consider clinically non-significant arrythmia and ischemic change as normal
  -  LVEF ≥ 55% measured by ECHO or MUGA scan
  Outcome measures
  -  Primary End-point
  -  The rate of pathologic complete response (pCR)
  -  No residual invasive cancer in breast
  -  Secondary End-point
  -  Clinical Response Rate
  -  Safety profiles for the preoperative use of concurrent trastuzumab and letrozole
  -  The rate of breast conservative surgery
  -  Total pathologic complete response (tpCR)
  -  No residual invasive cancer in breast and ipsilateral axilla
  -  Analysis of biomarkers based on baseline specimen and residual tumor
  -  Ki67 expression
  -  cDNA microarray: gene expression profiling
  -  Association between clinical response rate and circulating tumor cells (CTCs)
  -  CTCs are measured by CytoGen (SEOUL, KOREA)"

Eligibility: Inclusion Criteria:
  -  Invasive cancer (clinical stage IB-IIIC)
  -  Measurable tumor larger than 1cm
  -  ECOG status 0 or 1
  -  Postmenopausal women
  -  Age ≥55 years and amenorrhea
  -  Age <55 years and amenorrhea for ≥12 months with FSH >30 mIU/ml
  -  HER2 positive tumor
  -  3 positive on IHC
  -  2 positive on IHC with HER2 gene amplification on FISH or SISH using a single-probe or dual-probe
  -  Estrogen receptor positive tumor
  -  Positive ER expression with Allred score more than PS3/TS8 or modified Allred score more than PS4/TS7
  -  Eligible cardiac function
  -  Normal heard evaluated by ECG
  -  Consider clinically non-significant arrythmia and ischemic change as normal
  -  LVEF ≥ 55% measured by ECHO or MUGA scan
  Exclusion Criteria:
  -  Inflammatory breast cancer
  -  Bilateral breast cancer
  -  Patients with previous breast cancer history
  -  Patients with previous breast cancer treatment: Generally include hormone therapy, chemotherapy, and radiotherapy)
  -  Patients having uncontrolled heart problems
  -  Ischemic heart disease within 6 months
  -  Congestive heart failure more than NYHA class II
  -  Unstable angina
  -  Clinically significant pericarditis
  -  Amyloid heart disease

Relevance to patient case: not relevant