Ignite Creation Date:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2025-12-27 @ 6:15 PM
Study NCT ID:
NCT05693766
Status:
RECRUITING
Last Update Posted:
2025-10-24
First Post:
2023-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
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': 'D000069287', 'term': 'Capecitabine'}], 'ancestors': [{'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-02-16', 'size': 1183380, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-03-28T12:25', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 64}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2037-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-22', 'studyFirstSubmitDate': '2023-01-11', 'studyFirstSubmitQcDate': '2023-01-11', 'lastUpdatePostDateStruct': {'date': '2025-10-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression free survival', 'timeFrame': 'Up to 3 years'}], 'secondaryOutcomes': [{'measure': 'Overall survival at 2 years', 'timeFrame': 'Up to 2 years'}, {'measure': 'Overall survival at 5 years', 'timeFrame': 'Up to 5 years'}, {'measure': 'Overall survival at 10 years', 'timeFrame': 'Up to 10 years'}, {'measure': 'Clinical Benefit Rate', 'timeFrame': 'Approximately 6 months', 'description': 'Percentage of patients without disease progression at 6 months'}, {'measure': 'Overall response rate', 'timeFrame': 'Up to 3 years'}, {'measure': 'Incidence of adverse events', 'timeFrame': 'Up to 28 days post-treatment'}, {'measure': 'Overall impact of treatment toxicity', 'timeFrame': 'Up to 3 years', 'description': 'Will be measured using Functional Assessment of Cancer Therapy (FACT)-G (5 point Likert-type scale from 1 ("none at all") to 5 ("very much")'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Invasive Mammary Carcinoma', 'Metastatic Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This is an open-label, multicenter, two-arm Phase II clinical trial that will evaluate the impact of 2nd line chemotherapy (i.e. capecitabine) on survival in patients with non-Luminal A hormone receptor-positive (HR+) metastatic breast cancer (MBC)', 'detailedDescription': 'Primary Objective:\n\n\\- Determine the impact of early chemotherapy (i.e., capecitabine) versus endocrine therapy-based regimen on anti-tumor effect in patients with non-Luminal A hormone receptor-positive (HR+) metastatic breast cancer\n\nSecondary Objectives:\n\n* Compare the safety and tolerability of capecitabine versus endocrine therapy in patients with non-Luminal A hormone receptor-positive (HR+) metastatic breast cancer\n* Determine the impact of early chemotherapy (i.e., capecitabine) versus endocrine therapy-based regimen on anti-tumor effect in patients with non-Luminal A hormone receptor-positive (HR+) metastatic breast cancer\n\nCorrelatives:\n\n* Determine if the tumor mutations detected in cfDNA are early surrogates of response\n* Determine if the cfDNA results at disease progression show new genomic alterations potentially associated with resistance to therapy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed and dated written informed consent.\n* Subjects ≥ 18 years of age.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.\n* Clinical stage IV invasive mammary carcinoma or unresectable locoregional recurrence of invasive mammary carcinoma that is:\n\n * ER (\\>/=1%) and/or PR (\\>/= 1%) by IHC and HER2 negative (by IHC or FISH)\n* Previously exposed to an aromatase inhibitor (AI) or a selective estrogenreceptor modulator/ downregulator (SERM; SERD) + a CDK4/6 inhibitor.\n* Prior radiation permitted (if completed at least 2 weeks prior to study entry. Patients who have received prior radiotherapy must have recovered from toxicity (≤ grade 1) induced by this treatment (except for alopecia)\n* Patients with brain metastasis secondary to breast cancer and clinically stable for more than 4 weeks from completion of radiation treatment and off steroids\n* Evaluable disease (measurable or non-measurable)\n\n * Measurable disease, ie, at least 1 measurable lesion as per RECIST 1.1 (a lesion at a previously irradiated site may only be counted as a target lesion if there is clear sign of progression since the irradiation)\n * Patients with bone only disease allowed if possible to evaluate on radiological exams (eg.bone scan, PET/CT, CT, MRI) even if lesions are non-measurable according to RECIST1.1.\n* Adequate organ function including:\n\n * Absolute neutrophil count (ANC) ≥ 1.5 × 10\\^9/L\n * Platelets ≥ 100 × 10\\^9/L\n * Hemoglobin ≥ 8/g/dL (may have been transfused)\n * Total serum bilirubin ≤ 1.5 times upper limit of normal (ULN)\n * Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) ≤ 2.5 × ULN (or ≤ 5 × ULN if liver metastases are present)\n * Serum creatinine ≤ 1.5 x ULN or estimated creatinine clearance ≥ 50mL/min as calculated using the Cockcroft-Gault (CG) equation\n* For randomized patients only: tumors must be diagnosed as non-Luminal A using the Blueprint® and Mammaprint® tests\n\nExclusion Criteria:\n\n* Prior chemotherapy in the metastatic setting\n* Previous malignant disease other than breast cancer within the last 2 years with associated competing risk, with the exception of basal or squamous cell carcinoma of the skin, cervical carcinoma in situ, or low-risk cancers considered curatively treated (i.e. complete remission achieved at least 2 years prior to first dose of study drugs AND additional therapy not required while receiving study treatment).\n* Persisting symptoms related to prior therapy that has not reduced to Grade 1 \\[National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 5.0\\]; however, menopausal symptoms, alopecia, and sensory neuropathy Grade ≤ 2 is acceptable\n* Pregnant or breastfeeding females.'}, 'identificationModule': {'nctId': 'NCT05693766', 'acronym': 'INSIGHT', 'briefTitle': 'Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt-Ingram Cancer Center'}, 'officialTitle': 'Integrating Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort (INSIGHT)', 'orgStudyIdInfo': {'id': 'VICCBRE2256'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': "Physician's Choice of Endocrine-based Therapy_Non-Luminal A subtypes", 'interventionNames': ['Other: Endocrine-therapy', 'Other: MammoPrint ® and BluePrint assays']}, {'type': 'EXPERIMENTAL', 'label': 'Capecitabine_Non-Luminal A subtypes', 'interventionNames': ['Drug: Capecitabine', 'Other: MammoPrint ® and BluePrint assays']}], 'interventions': [{'name': 'Capecitabine', 'type': 'DRUG', 'description': '2000 mg taken by mouth twice daily for 7 days on, 7 days off', 'armGroupLabels': ['Capecitabine_Non-Luminal A subtypes']}, {'name': 'Endocrine-therapy', 'type': 'OTHER', 'description': 'Endocrine therapy administered', 'armGroupLabels': ["Physician's Choice of Endocrine-based Therapy_Non-Luminal A subtypes"]}, {'name': 'MammoPrint ® and BluePrint assays', 'type': 'OTHER', 'description': 'Archival tissue will be analyzed using the MammoPrint ® and BluePrint assays', 'armGroupLabels': ['Capecitabine_Non-Luminal A subtypes', "Physician's Choice of Endocrine-based Therapy_Non-Luminal A subtypes"]}]}, 'contactsLocationsModule': {'locations': [{'zip': '35249', 'city': 'Birmingham', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kyndall Thomas', 'role': 'CONTACT'}, {'name': 'Nusrat Jahan', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Alabama Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Vanderbilt-Ingram Service for Timely Access', 'role': 'CONTACT', 'email': 'cip@vumc.org', 'phone': '800-811-8480'}, {'name': 'Sonya Reid, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Vanderbilt University/Ingram Cancer Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Vanderbilt-Ingram Services for Timely Access', 'role': 'CONTACT', 'phone': '800-811-8480'}, {'name': 'Heather McArthur, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UT Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'centralContacts': [{'name': 'Vanderbilt-Ingram Services for Timely Access', 'role': 'CONTACT', 'email': 'cip@vumc.org', 'phone': '800-811-8480'}], 'overallOfficials': [{'name': 'Sonya Reid, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University/Ingram Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sonya Reid', 'class': 'OTHER'}, 'collaborators': [{'name': 'Agendia', 'class': 'INDUSTRY'}, {'name': 'Susan G. Komen Breast Cancer Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Medicine', 'investigatorFullName': 'Sonya Reid', 'investigatorAffiliation': 'Vanderbilt-Ingram Cancer Center'}}}}