Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2025-12-26 @ 2:15 AM
Study NCT ID:
NCT01275859
Status:
COMPLETED
Last Update Posted:
2017-08-29
First Post:
2011-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neoadjuvant Combined Endocrine and HER2 Target Therapy in Postmenopausal Women With ER and Her2 Positive Breast Cancer
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': 'D000077289', 'term': 'Letrozole'}, {'id': 'D000077341', 'term': 'Lapatinib'}], 'ancestors': [{'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'}, {'id': 'D011799', 'term': 'Quinazolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-26', 'studyFirstSubmitDate': '2011-01-12', 'studyFirstSubmitQcDate': '2011-01-12', 'lastUpdatePostDateStruct': {'date': '2017-08-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-01-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pCR', 'timeFrame': '2010 Nov- 2012 May', 'description': 'To evaluate the pathologic complete response (pCR) rate to lapatinib combined with letrozole in neoadjuvant setting'}], 'secondaryOutcomes': [{'measure': 'SUV for [18F]FES PET', 'timeFrame': '2010 Nov- 2012 May', 'description': '* To evaluate clinical overall response (cORR) rate, disease free survival (DFS), overall survival (OS)\n* To assess tolerability and QOL\n* To assess MRI response rate\n* To identify biological predictors of response to lapatinib combined letrozole treatment\n* To determine the correlation of \\[18F\\]FES PET with biological and imaging predictors of response to the combined modalities\n* To evaluate the diagnostic value of SUV for \\[18F\\]FES PET in the prediction of pathologic, clinical response to neoadjuvant HER2 target- and endocrine therapy'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Neoadjuvant', 'Letrozole', 'Lapatinib', 'Postmenopausal'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'Cross-talk between epidermal growth factors and the ER occurs at multiple levels and seems to play a crucial role in breast cancer progression and endocrine resistance.Combined HER1/HER2-targeted therapy with aromatase inhibitors for ER-positive and HER-2 positive postmenopausal breast cancer might enhance response and block emergence of endocrine resistant tumor.', 'detailedDescription': '1. To evaluate the efficacy of the neoadjuvant combination therapy with letrozole and lapatinib in postmenopausal patients with ER-positive and HER2-positive breast cancer.\n2. To assess markers predictive of treatment response and outcome in this setting.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent\n* Female patients\n* Histologically confirmed invasive breast cancer\n* Primary tumor greater than 2cm diameter, measured by sonography\n* N0-3 (any N if resectable) and no evidence of distant metastasis (M) (isolated supraclavicular node involvement allowed)\n* ER positive (intermediate and strong positive)\n* HER2 positive (IHC3+ or FISH positive in case of IHC 2+)\n* No evidence of metastasis (M0)\n* No prior hormonal, chemotherapy or radiotherapy is allowed\n* No breast operation other than biopsy to make diagnosis is allowed\n* Postmenopausal women with ECOG Performance Status of 0 or 1\n* Postmenopausal, as defined by any of the following:\n* At least 55 years of age\n* Under 55 years of age and amenorrheic for at least 12 months OR follicle-stimulating hormone (FSH) values ≥ 30 IU/L and estradiol levels ≤ 20 IU/L\n* Prior bilateral oophorectomy or prior radiation castration with amenorrhea for at least 6 months\n* Adequate hematopoietic, renal, hepatic function:\n\nExclusion Criteria:\n\n* Patients who received hormonal, chemotherapy or radiotherapy for breast cancer\n* Patients who underwent surgery for breast cancer\n* Patients with bilateral invasive breast cancer\n* Patients with inflammatory breast cancer (T4d)\n* Patients without primary tumor (T0) Inability to perform \\[18F\\]FES PET imaging due to physical inability, claustrophobia, or other mental illness.\n* ER poor disease as defined locally (e.g: Allred score 1-3, H-score\\<100)\n* Patients who have history of cancer other than in situ uterine cervix cancer or non-melanotic skin cancer\n* Chronic daily treatment with aspirin (\\>325mg/day) or clopidogrel (\\>75mg/day)\n* Chronic daily treatment with corticosteroids (dose of \\>10mg /day ethylprednisolone equivalent)\n* Clinically significant cardiovascular disease: CVA/stroke (\\<6month prior to enroll), MI (\\<6month prior to enroll), unstable angina, NYHA Grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication.\n* Hormone replacement therapy within 4 weeks of starting treatment\n* Known hypersensitivity to any of the study drugs including ditosylate monohydrate salt\n* Pregnant or nursing mother (if applicable)'}, 'identificationModule': {'nctId': 'NCT01275859', 'acronym': 'Neo-All-In', 'briefTitle': 'Neoadjuvant Combined Endocrine and HER2 Target Therapy in Postmenopausal Women With ER and Her2 Positive Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Asan Medical Center'}, 'officialTitle': 'Neoadjuvant Letrozole and Lapatinib in Postmenopausal Women With ER and Her2 Positive Breast Cancer', 'orgStudyIdInfo': {'id': '2009-0729'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Letrozole, Lapatinib', 'description': 'Letrozole 2.5mg po qd + Lapatinib 1500mg po qd for 18-21 wks', 'interventionNames': ['Drug: Letrozole, Lapatinib']}], 'interventions': [{'name': 'Letrozole, Lapatinib', 'type': 'DRUG', 'otherNames': ['Femara', 'Tykerb'], 'description': 'Letrozole 2.5mg po qd+ Lapatinib 1500mg po qd for 18-21 wks', 'armGroupLabels': ['Letrozole, Lapatinib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '138-736', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Nedical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Sung-Bae Kim, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asan Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asan Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Sung-Bae Kim', 'investigatorAffiliation': 'Asan Medical Center'}}}}