Ignite Creation Date:
2025-12-24 @ 1:32 PM
Ignite Modification Date:
2025-12-30 @ 10:22 PM
Study NCT ID:
NCT07216495
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-24
First Post:
2025-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Study of an Aerobic Exercise Intervention During Immune Checkpoint Inhibitor Therapy in Early-stage Triple Negative Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 33}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2030-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-23', 'studyFirstSubmitDate': '2025-10-10', 'studyFirstSubmitQcDate': '2025-10-10', 'lastUpdatePostDateStruct': {'date': '2025-10-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and adverse events (AEs)', 'timeFrame': 'Through study completion; an average of 1 year', 'description': 'Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Aerobic Exercise', 'Early Stage Triple Negative Breast Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'MD Anderson Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'To learn if participating in a supervised exercise program can help participants with early-stage TNBC who are receiving ICI therapy before undergoing breast surgery.', 'detailedDescription': 'Primary Objective To evaluate the feasibility of a supervised cardiorespiratory exercise program in participants with clinical stage 2-3 Triple Negative Breast Cancer (TNBC) undergoing neoadjuvant chemotherapy with immune checkpoint inhibitor therapy.\n\nSecondary Objectives To explore the relationship between cardiorespiratory exercise and circulating immune (CD8+ T) cells in the peripheral blood.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria\n\n1. female and male participants 18 years or older and willing to provide Informed Consent\n2. clinical stage 2 or 3 TNBC (estrogen receptor and progesterone receptor ≤ 10% by immunohistochemistry (IHC) and human epidermal growth factor-2 (HER2) negative (IHC 0, IHC1+, or IHC 2+ with negative fluorescence in situ hybridization))\n3. Physically able to walk independently without assistive device and able to march in place for 30 seconds without assistive device\n4. Eastern Co-Operative Oncology Group (ECOG) Performance Status 0-1\n5. Planned receipt of neoadjuvant chemoICI therapy (carboplatin/taxane in combination with pembrolizumab; taxane options are weekly paclitaxel or every 3 week docetaxel8,46)\n6. clearance to participate in the study by the patient's medical oncologist\n7. normal bone marrow function\n8. able to read/complete study forms/assessments and understand instructions in English\n\nExclusion criteria:\n\na) Any physical condition which hinders the ability to safely participate in exercise including: uncontrolled or symptomatic cardiac/respiratory disease (e.g. uncontrolled angina, unusual shortness of breath, congestive heart failure, symptomatic peripheral vascular disease), stroke/myocardial infarction in the past year, fragility fracture, recent or planned orthopedic surgery, or any comorbid condition precluding exercise per the treating physician b) receipt of medications known to influence immune function including corticosteroids (\\>10 mg prednisone equivalent), other immune-suppressive medication, or beta blockers47 c) Any infection or vaccination within the last 4 weeks d) e) Known HIV-positive participants on combination antiretroviral therapy f) concurrent participation in a therapeutic clinical trial or other exercise program g) pregnant h) medically advised to not exercise i) Unable to walk on a motor-driven treadmill for \\~30 minutes at study enrollment j) Adults unable to consent k) No external catheters/drains (e.g., nephrostomy tube, foley catheter). A colostomy or Ileostomy is acceptable.\n\nl) Prior or concurrent non-breast malignancy. Those with prior cancers treated with curative intent are eligible. Participants with known (or history) of hepatitis B positive, or hepatitis C positive infection"}, 'identificationModule': {'nctId': 'NCT07216495', 'briefTitle': 'Pilot Study of an Aerobic Exercise Intervention During Immune Checkpoint Inhibitor Therapy in Early-stage Triple Negative Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Pilot Study of an Aerobic Exercise Intervention During Immune Checkpoint Inhibitor Therapy in Early-stage Triple Negative Breast Cancer', 'orgStudyIdInfo': {'id': '2025-1303'}, 'secondaryIdInfos': [{'id': 'NCI-2025-07495', 'type': 'OTHER', 'domain': 'NCI-CTRP Clinical Registry'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acute cardiorespiratory exercise program', 'description': 'consisting of 4 in-clinic exercise sessions', 'interventionNames': ['Other: Exercise']}], 'interventions': [{'name': 'Exercise', 'type': 'OTHER', 'description': 'Cardiorespiratory training via treadmill walking for 30 minutes; participants will be supervised by a trained exercise physiologist.', 'armGroupLabels': ['Acute cardiorespiratory exercise program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'contacts': [{'name': 'Jasmine Sukumar, MD', 'role': 'CONTACT', 'email': 'jsukumar@mdanderson.org', 'phone': '713-264-1576'}, {'name': 'Jasmine Sukumar, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Jasmine Sukumar, MD', 'role': 'CONTACT', 'email': 'jsukumar@mdanderson.org', 'phone': '(713) 264-1576'}, {'name': 'Johana Campos', 'role': 'CONTACT', 'email': 'JCampos1@mdanderson.org', 'phone': '713-563-0977'}], 'overallOfficials': [{'name': 'Jasmine Sukumar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}