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

• Status: Completed
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Asan Medical Center
• Treatments: Lapatinib; Letrozole

Criteria

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)