Ignite Creation Date:
2025-12-24 @ 9:12 PM
Ignite Modification Date:
2025-12-31 @ 4:30 PM
Study NCT ID:
NCT02214004
Status:
UNKNOWN
Last Update Posted:
2018-02-15
First Post:
2014-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neoadjuvant Trastuzumab and Letrozole for Postmenopausal Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068878', 'term': 'Trastuzumab'}, {'id': 'D000077289', 'term': 'Letrozole'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 132}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2019-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-02-13', 'studyFirstSubmitDate': '2014-08-05', 'studyFirstSubmitQcDate': '2014-08-09', 'lastUpdatePostDateStruct': {'date': '2018-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-08-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The rate of pathologic complete response', 'timeFrame': 'At time of surgery', 'description': 'No residual invasive cancer in breast regardless of axilla'}], 'secondaryOutcomes': [{'measure': 'Clinical Response Rate', 'timeFrame': 'At time of surgery', 'description': 'Clinical response includes complete response, partial response and stable disease.'}, {'measure': 'Safety profiles for the preoperative use of concurrent trastuzumab and letrozole', 'timeFrame': 'Up to 3 months after surgery', 'description': 'Toxicity according to CTCAE protocol from the initiated day to 3 months after surgery'}, {'measure': 'The rate of breast conservative surgery', 'timeFrame': 'Up to 3 weeks after surgery', 'description': 'The rate of breast conservative surgery among the patients receiving surgery'}, {'measure': 'Total pathologic complete response (tpCR)', 'timeFrame': 'At time of surgery', 'description': 'No residual invasive cancer in breast and ipsilateral axilla'}, {'measure': 'Analysis of biomarkers based on baseline specimen and residual tumor', 'timeFrame': 'Baseline and at time of surgery', 'description': '* Ki67 expression\n* cDNA microarray: gene expression profiling'}, {'measure': 'Association between clinical response rate and circulating tumor cells (CTCs)', 'timeFrame': 'Baseline and at time of surgery', 'description': 'Association between clinical response rate and circulating tumor cells (CTCs)\n\n: CTCs are measured by CytoGen (SEOUL, KOREA)"'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Breast cancer', 'HER2', 'ER', 'Postmenopausal', 'Trastuzumab', 'Letrozole', 'Neoadjuvant endocrine treatment'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Eligibility criteria\n\n* Ages Eligible for Study: ≥ 20 years\n* Invasive cancer (clinical stage IB-IIIB)\n* Measurable tumor larger than 1cm\n* ECOG status 0 or 1\n* Postmenopausal women\n\n * Age ≥55 years and amenorrhea\n * Age \\<55 years and amenorrhea for ≥12 months with FSH \\>30 mIU/ml\n* HER2 positive tumor\n\n * 3 positive on IHC\n * 2 positive on IHC with HER2 gene amplification on FISH or SISH using a single-probe or dual-probe\n* Estrogen receptor positive tumor\n\n * Positive ER expression with Allred score more than PS3/TS8 or modified Allred score more than PS4/TS7\n* Eligible cardiac function\n\n * Normal heard evaluated by ECG\n\n * Consider clinically non-significant arrythmia and ischemic change as normal\n * LVEF ≥ 55% measured by ECHO or MUGA scan\n\nOutcome measures\n\n* Primary End-point\n\n * The rate of pathologic complete response (pCR)\n\n * No residual invasive cancer in breast\n* Secondary End-point\n\n * Clinical Response Rate\n * Safety profiles for the preoperative use of concurrent trastuzumab and letrozole\n * The rate of breast conservative surgery\n * Total pathologic complete response (tpCR)\n\n * No residual invasive cancer in breast and ipsilateral axilla\n * Analysis of biomarkers based on baseline specimen and residual tumor\n* Ki67 expression\n* cDNA microarray: gene expression profiling\n* Association between clinical response rate and circulating tumor cells (CTCs)\n\n * CTCs are measured by CytoGen (SEOUL, KOREA)"'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Invasive cancer (clinical stage IB-IIIC)\n* Measurable tumor larger than 1cm\n* ECOG status 0 or 1\n* Postmenopausal women\n\n * Age ≥55 years and amenorrhea\n * Age \\<55 years and amenorrhea for ≥12 months with FSH \\>30 mIU/ml\n* HER2 positive tumor\n\n * 3 positive on IHC\n * 2 positive on IHC with HER2 gene amplification on FISH or SISH using a single-probe or dual-probe\n* Estrogen receptor positive tumor\n\n * Positive ER expression with Allred score more than PS3/TS8 or modified Allred score more than PS4/TS7\n* Eligible cardiac function\n\n * Normal heard evaluated by ECG\n\n * Consider clinically non-significant arrythmia and ischemic change as normal\n * LVEF ≥ 55% measured by ECHO or MUGA scan\n\nExclusion Criteria:\n\n* Inflammatory breast cancer\n* Bilateral breast cancer\n* Patients with previous breast cancer history\n* Patients with previous breast cancer treatment: Generally include hormone therapy, chemotherapy, and radiotherapy)\n* Patients having uncontrolled heart problems\n\n * Ischemic heart disease within 6 months\n * Congestive heart failure more than NYHA class II\n * Unstable angina\n * Clinically significant pericarditis\n * Amyloid heart disease'}, 'identificationModule': {'nctId': 'NCT02214004', 'acronym': 'HERAKLES', 'briefTitle': 'Neoadjuvant Trastuzumab and Letrozole for Postmenopausal Women', 'organization': {'class': 'OTHER', 'fullName': 'Gangnam Severance Hospital'}, 'officialTitle': 'A Phase II Trial of Preoperative HER2 Targeting and Endocrine Therapy in Postmenopausal Women With HER2 and HR Positive Breast Cancer', 'orgStudyIdInfo': {'id': 'HERAKLES'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Trastuzumab and Letrozole', 'description': '\\- Concurrently initiate two drugs on Day 1 of Cycle 1', 'interventionNames': ['Drug: Trastuzumab', 'Drug: Letrozole']}], 'interventions': [{'name': 'Trastuzumab', 'type': 'DRUG', 'otherNames': ['Herceptin'], 'description': '\\- Eight times IV administration of trastuzumab per 3 weeks\n\n* Trastuzumab 8mg/kg on Day 1 of Cycle 1\n* Trastuzumab 6mg/kg from Day 1 of Cycle 2 to Day 1 of Cycle 8', 'armGroupLabels': ['Trastuzumab and Letrozole']}, {'name': 'Letrozole', 'type': 'DRUG', 'otherNames': ['Femara'], 'description': '\\- Daily letrozole 2.5 mg/day for 24 weeks', 'armGroupLabels': ['Trastuzumab and Letrozole']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Anyang', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Lee Su Kim, M.D.,Ph.D.', 'role': 'CONTACT', 'email': 'lskim0503@hallym.ac.kr'}], 'facility': 'Hallym University Sacred Heart Hospital', 'geoPoint': {'lat': 36.9577, 'lon': 127.1464}}, {'city': 'Busan', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Taehyun Kim, M.D.,Ph.D.', 'role': 'CONTACT'}], 'facility': 'Inje University Pusan Paik Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'city': 'Cheonan', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Junwon Min, M.D.,Ph.D.', 'role': 'CONTACT'}], 'facility': 'Dankook University Hospital', 'geoPoint': {'lat': 36.8065, 'lon': 127.1522}}, {'city': 'Goyang', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jae Il Kim, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'erythrokim@paik.ac.kr'}], 'facility': 'Ilsan Paik Hospital', 'geoPoint': {'lat': 36.21689, 'lon': 127.19731}}, {'city': 'Goyang', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Eun Sook Lee, M.D.,Ph.D.', 'role': 'CONTACT', 'email': 'eslee@ncc.re.kr'}], 'facility': 'National Cancer Center', 'geoPoint': {'lat': 36.21689, 'lon': 127.19731}}, {'zip': '135720', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Joon Jeong, M.D.,Ph.D.', 'role': 'CONTACT', 'email': 'gsjjoon@yuhs.ac', 'phone': '82220193370'}, {'name': 'Sung Gwe Ahn, M.D.', 'role': 'CONTACT', 'email': 'asg2004@yuhs.ac', 'phone': '82220193370'}], 'facility': 'Gangnam Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Byung Ho Son, M.D.,Ph.D.', 'role': 'CONTACT'}], 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Chan Heun Park, M.D.,Ph.D.', 'role': 'CONTACT', 'email': 'chanheun.park@samsung.com'}], 'facility': 'Kangbuk Samsung Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Woo Chul Noh, M.D.,Ph.D.', 'role': 'CONTACT', 'email': 'nohwoo@kcch.re.kr', 'phone': '8229701280'}], 'facility': 'Korea Institute of Radiological and Medical Sciences', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jeoung Won Bae, M.D.,Ph.D.', 'role': 'CONTACT'}], 'facility': 'Korea University Anam Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Seok Jin Nam, M.D.,Ph.D.', 'role': 'CONTACT', 'email': 'seokjin.nam@samsung.com'}], 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Dong Hui Cho', 'role': 'CONTACT'}], 'facility': 'Seoul Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Wonshik Han, M.D.,Ph.D.', 'role': 'CONTACT', 'email': 'hanw@snu.ac.kr'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Suwon', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Yongsik Jung, M.D.,Ph.D.', 'role': 'CONTACT', 'email': 'drjys@ajou.ac.kr'}], 'facility': 'Ajou University School of Medicine', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}], 'centralContacts': [{'name': 'Joon Jeong, M.D.,Ph.D.', 'role': 'CONTACT', 'email': 'gsjjoon@yuhs.ac', 'phone': '82220193370'}, {'name': 'Sung Gwe Ahn, M.D.', 'role': 'CONTACT', 'email': 'asg2004@yuhs.ac', 'phone': '82220194402'}], 'overallOfficials': [{'name': 'Joon Jeong, M.D.,Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gangnam Severance Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gangnam Severance Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Seoul National University Hospital', 'class': 'OTHER'}, {'name': 'Severance Hospital', 'class': 'OTHER'}, {'name': 'Samsung Medical Center', 'class': 'OTHER'}, {'name': 'Asan Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Joon Jeong', 'investigatorAffiliation': 'Gangnam Severance Hospital'}}}}