A Phase II trial of preoperative HER2 targeting and endocrine therapy in postmenopausal women with HER2 and HR positive breast cancer
- Conditions
- Neoplasms
- Registration Number
- KCT0001583
- Lead Sponsor
- Yonsei University Health System, Gangnam Severance Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 132
1) Patients must have histological confirmation that the patient has operable invasive breast cancer.
2) Measurable lesions = 1cm
3) Age = 20 years
4) ECOG performance status: 0 or 1
5) Postmenopausal women
Definition of postmenopausal
• Age = 55 years and no history of menstruation or
• Age < 55 years: no history of menstruation within the last 12 months and FSH(Follicle stimulating Hormone) = 30 mlU/mL
6) HER2(Human Epidermal Growth factor Receptor 2) Positive
• IHC(Immunohistochemistry) Score is 3+ or if IHC Score is 2+, (must have positive with FISH(Fluorescence in situ hybridization)/SISH(Silver enhanced in situ hybridization) tests)
7) ER(Estrogen Receptor) Positive
• Allred score = 3/8 or Modified Allred score = 4/7
8) Adequate organ and bone marrow function:
• WBC(White Blood Cell) =2.5x10^9/L
• ANC(Absolute Neutrophil Count) =1.5x10^9/L
• Platelet =100x10^9/L
• Hemoglobin =10g/dl
• Serum creatinine =1.5mg/dl
• AST(Aspartate aminotransgerase) and ALT(Alanine aminotransferase) =2 x ULN(Upper limit of normal)
• Alkaline phosphatase =2.5 x ULN
• Total bilirubin =1.5mg/dl
9) Adequate Cardiac Function
• Normal ECG(Electrocardiogram) results
(not Consider clinically non-significant arrythmia and ischemic change as normal)
• MUGA(Multi Gated Blood Pool Scan) or Echo(Echocardiography) shows LVEF(Left Ventricular ejection fraction) =55%
10) Ability to understand a written informed consent form, and the willingness to sign it.
1) Inflammatory breast cancer
2) Bilateral breast cancer
3) Previous surgical history of breast cancer (excluding biopsy for diagnostic purposes)
4) History of treatment for breast cancer
(Including hormone therapy, chemotherapy, and radiation therapy)
5) History of treatment for malignant tumor other than breast cancer within last five years.
(Excluding treated non-melanoma skin cancer and localized cervical cancer and no evidence of recurrence of thyroid cancer for 5 years after surgery)
6) Within the last six months, if the patients have any history below:
- Myocardial Infarction
- Uncontrolled or moderate cardiovascular diseases
- Heart failure (New York Heart Association(NYHA) Class II)
- Uncontrolled angina
- Clinically significant epicardial disease
- History of cardiac amyloidosis
7) Presence of any severe medical condition that, in the opinion of the investigator, would limit the patients successful participation.
8) Subjects who have enrolled other study and received treatment from other study within the last 4 weeks of starting of this study.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The rate of pathologic complete response(pCR)
- Secondary Outcome Measures
Name Time Method Clinical Response Rate;The rate of breast conservative surgery;Total pathologic complete response;Safety profiles for the preoperative use of concurrent treatuzumab and letrozole ;Analysis of biomarkers(Ki-67, cDNA microarray, CTCs Counting)