Spots Global Cancer Trial Database for Neoadjuvant Trastuzumab and Letrozole for Postmenopausal Women
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Trial Identification
Brief Title: Neoadjuvant Trastuzumab and Letrozole for Postmenopausal Women
Official Title: A Phase II Trial of Preoperative HER2 Targeting and Endocrine Therapy in Postmenopausal Women With HER2 and HR Positive Breast Cancer
Study ID: NCT02214004
Conditions
Study Description
Brief 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
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Hallym University Sacred Heart Hospital, Anyang, , Korea, Republic of
Inje University Pusan Paik Hospital, Busan, , Korea, Republic of
Dankook University Hospital, Cheonan, , Korea, Republic of
Ilsan Paik Hospital, Goyang, , Korea, Republic of
National Cancer Center, Goyang, , Korea, Republic of
Gangnam Severance Hospital, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Kangbuk Samsung Hospital, Seoul, , Korea, Republic of
Korea Institute of Radiological and Medical Sciences, Seoul, , Korea, Republic of
Korea University Anam Hospital, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Seoul Medical Center, Seoul, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Ajou University School of Medicine, Suwon, , Korea, Republic of
Contact Details
Name: Joon Jeong, M.D.,Ph.D.
Affiliation: Gangnam Severance Hospital
Role: PRINCIPAL_INVESTIGATOR
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