Ignite Creation Date:
2025-12-24 @ 1:20 PM
Ignite Modification Date:
2025-12-30 @ 7:13 PM
Study NCT ID:
NCT03988595
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-27
First Post:
2019-06-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercise Treatment With Standard Therapy for Metastatic Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-01-17', 'size': 880396, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-04-14T11:43', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Exercise therapy will consist of individualized walking delivered 3 to 5 times weekly for 24 weeks. This trial will evaluate four escalated doses of exercise (90 mins/wk, 150 mins/wk, 225 mins/wk, 300 mins/week, or 375 mins/week).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-06-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-26', 'studyFirstSubmitDate': '2019-06-13', 'studyFirstSubmitQcDate': '2019-06-13', 'lastUpdatePostDateStruct': {'date': '2025-08-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-06-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'maximum feasible dose (MFD)', 'timeFrame': '24 weeks', 'description': 'Feasibility is defined in terms of the relative dose intensive (RDI), the proportion of the planned exercise prescription that was completed without requiring a dose modification or interruption. The MFD is defined as the dose estimated to result in approximately 70% of patients achieving an RDI ≥ 75%.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Exercise', '19-113'], 'conditions': ['Hormone Receptor Positive Metastatic Breast Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mskcc.org/mskcc/html/44.cfm', 'label': 'Memorial Sloan Kettering Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'This study will test any good and bad effects of aerobic exercise performed while you are receiving the usual first-line treatment for metastatic breast cancer. The researchers think that exercise helps delay the development of resistance to hormone therapy while slowing the growth of tumors.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'genderBased': True, 'genderDescription': 'Breast Cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with histologically-confirmed, HR-positive (ER and/or PR), HER2-negative metastatic breast cancer (MBC)\n* Postmenopausal status defined by lack of menses for 2 years, oophorectomy, or medical ovarian suppression\n* Receiving first line endocrine-based therapy (tamoxifen, aromatase inhibitor, or fulvestrant; concurrent molecular therapy also allowed)\n* Sedentary (i.e., \\<60 minutes / week of exercise)\n* Age \\>18 years\n* BMI ≥ 18.5\n* Cleared for exercise participation as per screening clearance via PAR-Q+\n* Cleared for study participation as per screening consultation with an MSK Exercise Physiologist\n* Willingness to comply with all study-related procedures\n* Patients with "treated and stable" brain lesions of a duration of ≥ 2 months may be enrolled\n\nExclusion Criteria:\n\n* Life expectancy \\<6 months\n* Enrollment onto any other therapeutic investigational study\n* Mental impairment leading to inability to cooperate\n* Concurrent participation in weight loss or other exercise programs'}, 'identificationModule': {'nctId': 'NCT03988595', 'briefTitle': 'Exercise Treatment With Standard Therapy for Metastatic Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': 'Phase 1 Trial of Exercise Treatment With Concurrent First-Line Therapy for Hormone Receptor Positive Metastatic Breast Cancer', 'orgStudyIdInfo': {'id': '19-113'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'aerobic training 90 mins/wk', 'description': 'Exercise sessions will consist of individualized, walking delivered following a non-linear(i.e., exercise intensity is continually altered and progressed in conjunction with appropriate rest/recovery sessions across the entire intervention period) dosing schedule up to 7 individual treatment sessions/wk for 6 months. Remote supervised exercise sessions will be implemented and monitored using TeleEx. General physical activity as well as exercise performed outside of the structured treatment sessions will be evaluated via continuous monitoring using MSK approved telemedicine / wireless technology.', 'interventionNames': ['Other: Exercise Treatment']}, {'type': 'EXPERIMENTAL', 'label': 'aerobic training 150 mins/wk', 'description': 'Exercise sessions will consist of individualized, walking delivered following a non-linear(i.e., exercise intensity is continually altered and progressed in conjunction with appropriate rest/recovery sessions across the entire intervention period) dosing schedule up to 7 individual treatment sessions/wk for 6 months. Remote supervised exercise sessions will be implemented and monitored using TeleEx. General physical activity as well as exercise performed outside of the structured treatment sessions will be evaluated via continuous monitoring using MSK approved telemedicine / wireless technology.', 'interventionNames': ['Other: Exercise Treatment']}, {'type': 'EXPERIMENTAL', 'label': 'aerobic training 225 mins/wk', 'description': 'Exercise sessions will consist of individualized, walking delivered following a non-linear(i.e., exercise intensity is continually altered and progressed in conjunction with appropriate rest/recovery sessions across the entire intervention period) dosing schedule up to 7 individual treatment sessions/wk for 6 months. Remote supervised exercise sessions will be implemented and monitored using TeleEx. General physical activity as well as exercise performed outside of the structured treatment sessions will be evaluated via continuous monitoring using MSK approved telemedicine / wireless technology.', 'interventionNames': ['Other: Exercise Treatment']}, {'type': 'EXPERIMENTAL', 'label': 'aerobic training 300 mins/week', 'description': 'Exercise sessions will consist of individualized, walking delivered following a non-linear(i.e., exercise intensity is continually altered and progressed in conjunction with appropriate rest/recovery sessions across the entire intervention period) dosing schedule up to 7 individual treatment sessions/wk for 6 months. Remote supervised exercise sessions will be implemented and monitored using TeleEx. General physical activity as well as exercise performed outside of the structured treatment sessions will be evaluated via continuous monitoring using MSK approved telemedicine / wireless technology.', 'interventionNames': ['Other: Exercise Treatment']}, {'type': 'EXPERIMENTAL', 'label': 'aerobic training 375 mins/week', 'description': 'Exercise sessions will consist of individualized, walking delivered following a non-linear(i.e., exercise intensity is continually altered and progressed in conjunction with appropriate rest/recovery sessions across the entire intervention period) dosing schedule up to 7 individual treatment sessions/wk for 6 months. Remote supervised exercise sessions will be implemented and monitored using TeleEx. General physical activity as well as exercise performed outside of the structured treatment sessions will be evaluated via continuous monitoring using MSK approved telemedicine / wireless technology.', 'interventionNames': ['Other: Exercise Treatment']}], 'interventions': [{'name': 'Exercise Treatment', 'type': 'OTHER', 'description': 'Exercise sessions will consist of individualized, walking delivered following a non-linear (i.e.,exercise intensity is continually altered and progressed in conjunction with appropriate rest/recovery sessions across the entire intervention period) dosing schedule up to 7 individual treatment sessions/wk for 6 months. Remote supervised exercise sessions will be implemented and monitored using TeleEx. General physical activity as well as exercise performed outside of the structured treatment sessions will be evaluated via continuous monitoring using MSK approved telemedicine / wireless technology.', 'armGroupLabels': ['aerobic training 150 mins/wk', 'aerobic training 225 mins/wk', 'aerobic training 300 mins/week', 'aerobic training 375 mins/week', 'aerobic training 90 mins/wk']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University (Data Collection Only)', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Hospital (Data Collection Only)', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '07920', 'city': 'Basking Ridge', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)', 'geoPoint': {'lat': 40.70621, 'lon': -74.54932}}, {'zip': '07748', 'city': 'Middletown', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Monmouth (Limited Protocol Activities)', 'geoPoint': {'lat': 40.39428, 'lon': -74.11709}}, {'zip': '07645', 'city': 'Montvale', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Bergen (Limited Protocol Activities)', 'geoPoint': {'lat': 41.04676, 'lon': -74.02292}}, {'zip': '11725', 'city': 'Commack', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center @ Suffolk (Limited protocol activity)', 'geoPoint': {'lat': 40.84288, 'lon': -73.29289}}, {'zip': '10604', 'city': 'Harrison', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Westchester (Limited Protocol Activities)', 'geoPoint': {'lat': 40.96899, 'lon': -73.71263}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Health Systems (Montefiore Medical Center) (Data Collection Only)', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '11553', 'city': 'Uniondale', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Nassau (Limited Protocol Activities)', 'geoPoint': {'lat': 40.70038, 'lon': -73.59291}}], 'overallOfficials': [{'name': 'Jessica Scott, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'ipdSharingStatementModule': {'infoTypes': ['SAP', 'ICF'], 'ipdSharing': 'YES', 'description': 'Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}