Status:
UNKNOWN
Neoadjuvant Trastuzumab and Letrozole for Postmenopausal Women
Lead Sponsor:
Gangnam Severance Hospital
Collaborating Sponsors:
Seoul National University Hospital
Severance Hospital
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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-posi...
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...
Eligibility Criteria
Inclusion
- Invasive cancer (clinical stage IB-IIIC)
- 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
Exclusion
- Inflammatory breast cancer
- Bilateral breast cancer
- Patients with previous breast cancer history
- Patients with previous breast cancer treatment: Generally include hormone therapy, chemotherapy, and radiotherapy)
- Patients having uncontrolled heart problems
- Ischemic heart disease within 6 months
- Congestive heart failure more than NYHA class II
- Unstable angina
- Clinically significant pericarditis
- Amyloid heart disease
Key Trial Info
Start Date :
March 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2019
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT02214004
Start Date
March 1 2015
End Date
June 1 2019
Last Update
February 15 2018
Active Locations (14)
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1
Hallym University Sacred Heart Hospital
Anyang, South Korea
2
Inje University Pusan Paik Hospital
Busan, South Korea
3
Dankook University Hospital
Cheonan, South Korea
4
Ilsan Paik Hospital
Goyang, South Korea