Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2026-02-23 @ 9:00 PM
Study NCT ID:
NCT01777958
Status:
COMPLETED
Last Update Posted:
2020-12-14
First Post:
2013-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HELENA Study: An Observational Study of Perjeta (Pertuzumab) in First-Line Treatment in Patients With Her2-Positive Advanced Breast Cancer After Adjuvant Herceptin Therapy
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 135}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-11-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-10', 'studyFirstSubmitDate': '2013-01-25', 'studyFirstSubmitQcDate': '2013-01-25', 'lastUpdatePostDateStruct': {'date': '2020-12-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-01-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-11-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Median progression-free survival in routine clinical practice', 'timeFrame': 'approximately 7.5 years'}], 'secondaryOutcomes': [{'measure': 'Dosage/schedule: Initiation/duration/modification/discontinuation of Perjeta administration', 'timeFrame': 'approximately 7.5 years'}, {'measure': 'Clinical/demographic patients characteristics at initiation of treatment', 'timeFrame': 'approximately 7.5 years'}, {'measure': 'Safety: Incidence of adverse events', 'timeFrame': 'approximately 7.5 years'}, {'measure': 'Patient reported outcome: Quality of life (FACT B questionnaire)', 'timeFrame': 'approximately 7.5 years'}]}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This observational study will evaluate the efficacy, safety and patient reported quality of life of palliative first-line Perjeta (pertuzumab) in combination with Herceptin (trastuzumab) in patients with HER2-positive advanced breast cancer (metastatic or locally recurrent, inoperable) who relapsed after completed adjuvant Herceptin therapy. Additionally, information on selection criteria of breast cancer patients treated first-line with Perjeta, Herceptin and chemotherapy and their treatment duration will be collected and analyzed. Data will be collected from eligible patients for up to 20 months of treatment and 24 months of follow-up.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Female patients with HER2-positive advanced breast cancer (metastatic or locally recurrent, inoperable)who relapsed after adjuvant Herceptin therapy, with indication for treatment with Perjeta in combination with Herceptin', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female adult patients, \\>/= 18 years of age\n* HER2-positive advanced breast cancer (metastatic or locally recurrent, inoperable) relapsing after completed adjuvant Herceptin therapy\n* Indication for first-line treatment with Perjeta in combination with Herceptin and chemotherapy according to the Summary of Product Characteristics\n* Prior Herceptin therapy as systemic adjuvant treatment (postoperative treatment in a potentially curable setting); additional upfront neoadjuvant Herceptin therapy is allowed\n* No prior chemotherapy and/or immunotherapy for advanced (metastatic or locally recurrent, inoperable) HER2-positive breast cancer\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women\n* Contraindications to Perjeta, Herceptin or concomitant chemotherapy according to the Summary of Product Characteristics\n* No Herceptin treatment for early breast cancer in the adjuvant setting'}, 'identificationModule': {'nctId': 'NCT01777958', 'briefTitle': 'HELENA Study: An Observational Study of Perjeta (Pertuzumab) in First-Line Treatment in Patients With Her2-Positive Advanced Breast Cancer After Adjuvant Herceptin Therapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'Noninterventional Study - Advanced HER2-positive Breast Cancer (Metastatic or Locally Recurrent, Inoperable): First-Line Treatment With PERJETA After Adjuvant Herceptin Therapy (HELENA)', 'orgStudyIdInfo': {'id': 'ML28750'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort'}]}, 'contactsLocationsModule': {'locations': [{'zip': '60431', 'city': 'Frankfurt', 'country': 'Germany', 'facility': 'AGAPLESION Markus-Krankenhaus', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}