Neoadjuvant Trastuzumab and Letrozole for Postmenopausal Women
NCT ID: NCT02214004
Last Updated: 2018-02-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
132 participants
INTERVENTIONAL
2015-03-31
2019-06-30
Brief Summary
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Detailed Description
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* 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)"
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Trastuzumab and Letrozole
\- Concurrently initiate two drugs on Day 1 of Cycle 1
Trastuzumab
\- Eight times IV administration of trastuzumab per 3 weeks
* Trastuzumab 8mg/kg on Day 1 of Cycle 1
* Trastuzumab 6mg/kg from Day 1 of Cycle 2 to Day 1 of Cycle 8
Letrozole
\- Daily letrozole 2.5 mg/day for 24 weeks
Interventions
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Trastuzumab
\- Eight times IV administration of trastuzumab per 3 weeks
* Trastuzumab 8mg/kg on Day 1 of Cycle 1
* Trastuzumab 6mg/kg from Day 1 of Cycle 2 to Day 1 of Cycle 8
Letrozole
\- Daily letrozole 2.5 mg/day for 24 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
FEMALE
No
Sponsors
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Seoul National University Hospital
OTHER
Severance Hospital
OTHER
Samsung Medical Center
OTHER
Asan Medical Center
OTHER
Gangnam Severance Hospital
OTHER
Responsible Party
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Joon Jeong
Professor
Principal Investigators
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Joon Jeong, M.D.,Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Gangnam Severance Hospital
Locations
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Hallym University Sacred Heart Hospital
Anyang, , South Korea
Inje University Pusan Paik Hospital
Busan, , South Korea
Dankook University Hospital
Cheonan, , South Korea
Ilsan Paik Hospital
Goyang, , South Korea
National Cancer Center
Goyang, , South Korea
Gangnam Severance Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Kangbuk Samsung Hospital
Seoul, , South Korea
Korea Institute of Radiological and Medical Sciences
Seoul, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Seoul Medical Center
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Ajou University School of Medicine
Suwon, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Taehyun Kim, M.D.,Ph.D.
Role: primary
Junwon Min, M.D.,Ph.D.
Role: primary
Byung Ho Son, M.D.,Ph.D.
Role: primary
Jeoung Won Bae, M.D.,Ph.D.
Role: primary
Dong Hui Cho
Role: primary
Other Identifiers
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HERAKLES
Identifier Type: -
Identifier Source: org_study_id
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