Patient case: 56-year-old female with breast cancer; genetic feature: ERBB2

Clinical trial: Neoadjuvant Combined Endocrine and HER2 Target Therapy in Postmenopausal Women With ER and Her2 Positive Breast Cancer

Summary: Cross-talk between epidermal growth factors and the ER occurs at multiple levels and seems to play a crucial role in breast cancer progression and endocrine resistance.Combined HER1/HER2-targeted therapy with aromatase inhibitors for ER-positive and HER-2 positive postmenopausal breast cancer might enhance response and block emergence of endocrine resistant tumor.

Detailed description: 1. To evaluate the efficacy of the neoadjuvant combination therapy with letrozole and lapatinib in postmenopausal patients with ER-positive and HER2-positive breast cancer.
  2. To assess markers predictive of treatment response and outcome in this setting.

Eligibility: Inclusion Criteria:
  -  Written informed consent
  -  Female patients
  -  Histologically confirmed invasive breast cancer
  -  Primary tumor greater than 2cm diameter, measured by sonography
  -  N0-3 (any N if resectable) and no evidence of distant metastasis (M) (isolated supraclavicular node involvement allowed)
  -  ER positive (intermediate and strong positive)
  -  HER2 positive (IHC3+ or FISH positive in case of IHC 2+)
  -  No evidence of metastasis (M0)
  -  No prior hormonal, chemotherapy or radiotherapy is allowed
  -  No breast operation other than biopsy to make diagnosis is allowed
  -  Postmenopausal women with ECOG Performance Status of 0 or 1
  -  Postmenopausal, as defined by any of the following:
  -  At least 55 years of age
  -  Under 55 years of age and amenorrheic for at least 12 months OR follicle-stimulating hormone (FSH) values ≥ 30 IU/L and estradiol levels ≤ 20 IU/L
  -  Prior bilateral oophorectomy or prior radiation castration with amenorrhea for at least 6 months
  -  Adequate hematopoietic, renal, hepatic function:
  Exclusion Criteria:
  -  Patients who received hormonal, chemotherapy or radiotherapy for breast cancer
  -  Patients who underwent surgery for breast cancer
  -  Patients with bilateral invasive breast cancer
  -  Patients with inflammatory breast cancer (T4d)
  -  Patients without primary tumor (T0) Inability to perform [18F]FES PET imaging due to physical inability, claustrophobia, or other mental illness.
  -  ER poor disease as defined locally (e.g: Allred score 1-3, H-score<100)
  -  Patients who have history of cancer other than in situ uterine cervix cancer or non-melanotic skin cancer
  -  Chronic daily treatment with aspirin (>325mg/day) or clopidogrel (>75mg/day)
  -  Chronic daily treatment with corticosteroids (dose of >10mg /day ethylprednisolone equivalent)
  -  Clinically significant cardiovascular disease: CVA/stroke (<6month prior to enroll), MI (<6month prior to enroll), unstable angina, NYHA Grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication.
  -  Hormone replacement therapy within 4 weeks of starting treatment
  -  Known hypersensitivity to any of the study drugs including ditosylate monohydrate salt
  -  Pregnant or nursing mother (if applicable)

Relevance to patient case: definitely relevant