Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2025-12-25 @ 9:10 PM
Study NCT ID:
NCT00080756
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-08-28
First Post:
2004-04-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Deslorelin Combined With Low-Dose Add-Back Estradiol and Testosterone in Preventing Breast Cancer in Premenopausal Women Who Are at High Risk for This Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'releaseDate': '2024-09-17', 'unreleaseDate': '2024-09-17'}, {'resetDate': '2024-10-10', 'releaseDate': '2024-09-18'}, {'resetDate': '2025-11-20', 'releaseDate': '2025-11-10'}], 'estimatedResultsFirstSubmitDate': '2024-09-17'}}, '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': 'D004958', 'term': 'Estradiol'}, {'id': 'C066438', 'term': 'deslorelin'}, {'id': 'D043343', 'term': 'Testosterone Propionate'}, {'id': 'D057832', 'term': 'Watchful Waiting'}], 'ancestors': [{'id': 'D004963', 'term': 'Estrenes'}, {'id': 'D004962', 'term': 'Estranes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D045166', 'term': 'Estradiol Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D013739', 'term': 'Testosterone'}, {'id': 'D000737', 'term': 'Androstenols'}, {'id': 'D000736', 'term': 'Androstenes'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D045165', 'term': 'Testosterone Congeners'}, {'id': 'D017063', 'term': 'Outcome Assessment, Health Care'}, {'id': 'D010043', 'term': 'Outcome and Process Assessment, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2004-03-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-10-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-26', 'studyFirstSubmitDate': '2004-04-07', 'studyFirstSubmitQcDate': '2004-04-07', 'lastUpdatePostDateStruct': {'date': '2024-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2004-04-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-09-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment effects and correlation of changes in morphometrics and biomarkers as assessed by mammogram and magnetic resonance image (MRI) densities on days 1 and 300', 'timeFrame': 'Day 300'}, {'measure': 'Perspectives about risk reduction options and their impact on quality of life (QOL) as assessed by Medical Outcomes 36-item short-form version, Health Perceptions scale, and Body Image scale on days 1, 169, and 300, and then every 6 months for 2 years', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['breast cancer', 'BRCA1 mutation carrier', 'BRCA2 mutation carrier'], 'conditions': ['brca1 Mutation Carrier', 'brca2 Mutation Carrier', 'Breast Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Deslorelin combined with low-dose add-back estradiol and testosterone (given to replace hormones suppressed by deslorelin) may be effective in preventing breast cancer in at-risk women.\n\nPURPOSE: This phase II trial is studying how well giving deslorelin together with estradiol and testosterone works in preventing breast cancer in premenopausal women who are at high risk for this disease.', 'detailedDescription': 'OBJECTIVES:\n\nI. Assess the effects on the breast of treatment with the gonadotropin-releasing hormone agonist (GnRHA)-based regimen in breast cancer (BRCA) gene mutation carriers, including correlation of changes in mammographic and magnetic resonance imaging (MRI) densities with tissue morphometrics and biomarkers.\n\nII. Evaluate perspectives about risk reduction options and impact on quality-of-life (QOL) measures of participation in the chemopreventive protocol and in risk reduction surgery.\n\nOUTLINE:\n\nGROUP 1: Patients receive deslorelin, estradiol, and testosterone intranasally once daily (QD) for 6 months. Patients then undergo planned risk reduction mastectomy.\n\nGROUP 2: Patients receive deslorelin, estradiol, and testosterone intranasally QD for 10 months. Patients then undergo continued surveillance through 10 months.\n\nAfter completion of study treatment, patients are followed up every 6 months for 2 years.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '48 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must generally be in good health with lab values and physical examination within normal limits\n* Known high risk of breast cancer due to BRCA mutation or empiric risk \\> 30% lifetime by the Claus model\n* No evidence or history of pervious cancer, except non-melanoma skin cancer\n* Premenopausal women planning risk reduction mastectomy in 6 months or more (Group 1) or continued surveillance (Group 2)\n* Prior tubal ligation or willing to use a non-hormonal barrier method of contraception\n* Signed the Informed Consent Form document for this study in accordance with all Federal, State and Institutional regulations\n* Must be current non-smoker\n\nExclusion Criteria:\n\n* GnRHA treatment within 12 months of study entry\n* Nasal polyposis, atrophic rhinitis, severe allergic or vasomotor rhinitis, or sinusitis requiring current treatment or treatment for more than 3 months in the previous year\n* Concurrent medications including: corticosteroids (prednisone, prednisolone, cortisone acetate, Decadron, Deltasone, hydrocortisone, Hydrocortone, Medrol), estrogens, progestins or androgens, including oral, implanted, or injected contraceptive; (At least 6 months must have elapsed since the last use of an implanted or injected contraceptive such as Norplant)\n* Pregnant or breast-feeding or have been so in the last six months\n* Immeasurable breast density on mammogram'}, 'identificationModule': {'nctId': 'NCT00080756', 'briefTitle': 'Deslorelin Combined With Low-Dose Add-Back Estradiol and Testosterone in Preventing Breast Cancer in Premenopausal Women Who Are at High Risk for This Disease', 'organization': {'class': 'OTHER', 'fullName': 'City of Hope Medical Center'}, 'officialTitle': 'Biomarkers, Breast Density And Risk Reduction Perspectives In BRCA Carriers', 'orgStudyIdInfo': {'id': '02164'}, 'secondaryIdInfos': [{'id': 'P30CA033572', 'link': 'https://reporter.nih.gov/quickSearch/P30CA033572', 'type': 'NIH'}, {'id': 'CHNMC-IRB-02164'}, {'id': 'CDR0000355156', 'type': 'REGISTRY', 'domain': 'NCI PDQ'}, {'id': 'NCI-2011-00975', 'type': 'REGISTRY', 'domain': 'NCI CTRP'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1 (planned risk reduction mastectomy)', 'description': 'Patients receive deslorelin, estradiol, and testosterone intranasally QD for 6 months. Patients then undergo planned risk reduction mastectomy.', 'interventionNames': ['Biological: therapeutic estradiol', 'Drug: deslorelin', 'Drug: therapeutic testosterone', 'Procedure: therapeutic conventional surgery', 'Procedure: quality-of-life assessment', 'Other: laboratory biomarker analysis']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2 (continued survaillance)', 'description': 'Patients receive deslorelin, estradiol, and testosterone intranasally QD for 10 months. Patients then undergo continued surveillance through 10 months.', 'interventionNames': ['Biological: therapeutic estradiol', 'Drug: deslorelin', 'Drug: therapeutic testosterone', 'Other: active surveillance', 'Procedure: quality-of-life assessment', 'Other: laboratory biomarker analysis']}], 'interventions': [{'name': 'therapeutic estradiol', 'type': 'BIOLOGICAL', 'description': '0.35mg/100ul per day as a nasal spray', 'armGroupLabels': ['Group 1 (planned risk reduction mastectomy)', 'Group 2 (continued survaillance)']}, {'name': 'deslorelin', 'type': 'DRUG', 'description': '1mg/100ul per day as a nasal spray', 'armGroupLabels': ['Group 1 (planned risk reduction mastectomy)', 'Group 2 (continued survaillance)']}, {'name': 'therapeutic testosterone', 'type': 'DRUG', 'description': '0.275mg/100ul per day as a nasal spray', 'armGroupLabels': ['Group 1 (planned risk reduction mastectomy)', 'Group 2 (continued survaillance)']}, {'name': 'therapeutic conventional surgery', 'type': 'PROCEDURE', 'description': 'Undergo risk reduction mastectomy', 'armGroupLabels': ['Group 1 (planned risk reduction mastectomy)']}, {'name': 'active surveillance', 'type': 'OTHER', 'description': 'Undergo continued surveillance', 'armGroupLabels': ['Group 2 (continued survaillance)']}, {'name': 'quality-of-life assessment', 'type': 'PROCEDURE', 'description': 'Ancillary studies', 'armGroupLabels': ['Group 1 (planned risk reduction mastectomy)', 'Group 2 (continued survaillance)']}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Group 1 (planned risk reduction mastectomy)', 'Group 2 (continued survaillance)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91010-3000', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope Medical Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}], 'overallOfficials': [{'name': 'Jeffrey Weitzel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'City of Hope Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'City of Hope Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-09-17', 'type': 'RELEASE'}, {'date': '2024-09-17', 'type': 'UNRELEASE'}, {'date': '2024-09-18', 'type': 'RELEASE'}, {'date': '2024-10-10', 'type': 'RESET'}, {'date': '2025-11-10', 'type': 'RELEASE'}, {'date': '2025-11-20', 'type': 'RESET'}], 'unpostedResponsibleParty': 'City of Hope Medical Center'}}}}