Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2025-12-26 @ 3:44 AM
Study NCT ID:
NCT05900895
Status:
RECRUITING
Last Update Posted:
2025-11-20
First Post:
2023-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Estradiol Plus Olaparib for Breast Cancer (PHOEBE)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], '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'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C531550', 'term': 'olaparib'}, {'id': 'D004958', 'term': 'Estradiol'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Single-arm, 3+3 design with a dose-expansion cohort.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2023-05-24', 'studyFirstSubmitQcDate': '2023-06-02', 'lastUpdatePostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-06-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine the Phase II dose of olaparib in combination with 17b-estradiol', 'timeFrame': '8 weeks', 'description': 'Determine the safety and recommended Phase II dose of olaparib in combination with 17b-estradiol in post-menopausal patients with advanced ER+/HER2- breast cancer.'}], 'secondaryOutcomes': [{'measure': 'Clinical benefit rate', 'timeFrame': '6 months', 'description': 'The proportion of evaluable patients experiencing clinical benefit (stable disease at 24 weeks, complete or partial response per RECIST) will be measured.'}, {'measure': 'Objective response rate', 'timeFrame': '6 months', 'description': 'The proportion of evaluable patients experiencing objective response (complete or partial response per RECIST) will be measured.'}, {'measure': 'Progression-free survival', 'timeFrame': '12 months', 'description': 'Progression-free survival will be measured by measuring the length of time between the start of study treatment until the time of cancer progression or death from any cause.'}, {'measure': 'Plasma Olaparib concentration', 'timeFrame': '6 hours', 'description': 'The concentration of Olaparib in plasma will be measured over 6 hours.'}, {'measure': 'Plasma 17b-Estradiol/Estrone concentration', 'timeFrame': '6 hours', 'description': 'The concentration of 17b-Estradiol/Estrone in plasma will be measured over 6 hours.'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['metastatic', 'locally advanced', 'estradiol therapy', 'olaparib'], 'conditions': ['Metastatic Breast Cancer']}, 'descriptionModule': {'briefSummary': 'Determine the safety and recommended Phase II dose of olaparib in combination with 17b-estradiol in post-menopausal patients with advanced ER+/HER2- breast cancer.', 'detailedDescription': 'Patients with endocrine-resistant ER+/HER2- breast cancer are eligible. Patients will be treated with the combination of 17b-estradiol and olaparib for 2 cycles, and then treated with single-agent 17b-estradiol until disease progression. Clinical benefit, progression-free survival, objective response, tumor metabolic response, and toxicity will be determined.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Post-menopausal women with ER+/HER2- breast cancer.\n* Metastatic or locoregional recurrence not amenable to treatment with curative intent.\n* Received ≥1 prior line of endocrine-based therapy in the advanced/metastatic setting.\n\nExclusion Criteria:\n\n* During study treatment, no concurrent anti-cancer therapies are allowed with the following exceptions:\n\n o Anti-resorptive bone therapies (e.g., bisphosphonates, denosumab) permitted.\n* Any investigational cancer therapy or systemic chemotherapy in the last 3 weeks.\n* Any radiation therapy in the last 2 weeks.\n* Known CNS disease, unless clinically stable for ≥ 3 months.\n* Concomitant use of known strong or moderate CYP3A inhibitors.\n* Persistent toxicities (≥CTCAE grade 2) caused by previous cancer therapy.\n* History of any of the following:\n\n * Deep venous thrombosis\n * Pulmonary embolism\n * Stroke\n * Acute myocardial infarction\n * Congestive heart failure\n * Previous malignancy not treated with curative intent, or with an estimated recurrence risk ≥30%\n * Severe renal impairment (creatinine clearance ≤ 30 mL/min).'}, 'identificationModule': {'nctId': 'NCT05900895', 'acronym': 'PHOEBE', 'briefTitle': 'Estradiol Plus Olaparib for Breast Cancer (PHOEBE)', 'organization': {'class': 'OTHER', 'fullName': 'Dartmouth-Hitchcock Medical Center'}, 'officialTitle': 'Phase 1b Study of Olaparib and Estradiol in Advanced ER+ Breast Cancer (PHOEBE)', 'orgStudyIdInfo': {'id': 'STUDY02002007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Arm', 'description': 'Participants receive 2 cycles of olaparib in combination with 17b-estradiol and then continue to be treated with single-agent 17b-estradiol until disease progression.', 'interventionNames': ['Drug: Olaparib', 'Drug: 17b-estradiol']}], 'interventions': [{'name': 'Olaparib', 'type': 'DRUG', 'otherNames': ['Lynparza'], 'description': 'Participants will be treated with olaparib at the approved doses for the treatment of subtypes of breast cancer or at reduced dose/frequency for participants with moderate renal impairment.', 'armGroupLabels': ['Treatment Arm']}, {'name': '17b-estradiol', 'type': 'DRUG', 'otherNames': ['Estrace'], 'description': '17b-estradiol will be taken orally three times per day.', 'armGroupLabels': ['Treatment Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03756', 'city': 'Lebanon', 'state': 'New Hampshire', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mary D Chamberlin, MD', 'role': 'CONTACT', 'email': 'mary.d.chamberlin@hitchcock.org', 'phone': '603-653-6181'}, {'name': 'Ashley E Gaughan-Maher, MA', 'role': 'CONTACT', 'email': 'ashley.e.gaughan-maher@hitchcock.org', 'phone': '603-653-0628'}, {'name': 'Mary D Chamberlin, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Dartmouth Cancer Center', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}], 'centralContacts': [{'name': 'Research Nurse', 'role': 'CONTACT', 'email': 'Cancer.Research.Nurse@dartmouth.edu', 'phone': '1-800-639-6918'}], 'overallOfficials': [{'name': 'Mary Chamberlin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dartmouth-Hitchcock Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mary D Chamberlin', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dartmouth-Hitchcock Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine', 'investigatorFullName': 'Mary D Chamberlin', 'investigatorAffiliation': 'Dartmouth-Hitchcock Medical Center'}}}}