Neoadjuvant Letrozole and Lapatinib in Postmenopausal Women With ER and Her2 Positive Breast Cancer
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)