Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2026-02-22 @ 6:43 PM
Study NCT ID:
NCT03906669
Status:
UNKNOWN
Last Update Posted:
2023-11-22
First Post:
2018-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Window of Opportunity Study of Pre-operative Endocrine Therapy With and Without Prometrium in Postmenopausal Women With Early Stage Breast Hormone Receptor Positive (HR+) Human Epidermal Receptor 2 Negative (HER2-) Breast Cancer.
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': 'D000077289', 'term': 'Letrozole'}, {'id': 'D011374', 'term': 'Progesterone'}, {'id': 'D013629', 'term': 'Tamoxifen'}], 'ancestors': [{'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D003339', 'term': 'Corpus Luteum Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D045167', 'term': 'Progesterone Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D013267', 'term': 'Stilbenes'}, {'id': 'D001597', 'term': 'Benzylidene Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-20', 'studyFirstSubmitDate': '2018-09-18', 'studyFirstSubmitQcDate': '2019-04-05', 'lastUpdatePostDateStruct': {'date': '2023-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Define a gene set as a predictive biomarker for a reduction in Ki67', 'timeFrame': '4 years', 'description': 'Expression of gene signature will be tested in the pre- and post-intervention tissues using the Nanostring nCounter system'}, {'measure': 'Evaluate changes in the apoptotic markers Bcl-2 and Caspase 3 in the tumors following intervention', 'timeFrame': '4 years', 'description': 'Immunohistochemistry of the pre and post intervention tissue samples'}, {'measure': 'Evaluate changes in ER, PR, AR, FoxA1, Cyclin D1 protein and mRNA expression in the tumors following intervention', 'timeFrame': '4 years', 'description': 'Immunohistochemistry of the pre and post intervention tissue samples'}], 'primaryOutcomes': [{'measure': 'Geometric mean suppression of proliferation marker Ki67', 'timeFrame': 'After two weeks of intervention, compared with baseline', 'description': 'The geometric mean suppression of the centrally assessed proliferation marker Ki67, after two weeks of intervention, compared with baseline'}], 'secondaryOutcomes': [{'measure': 'Safety and tolerability: number of participants with treatment-related adverse events as assessed by CTCAE v4.0', 'timeFrame': '2 years', 'description': 'Safety and tolerability of combination therapy (NCI-CTCAE v4.0)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['early stage breast cancer', 'prometrium', 'progesterone', 'post-menopausal', 'endocrine therapy'], 'conditions': ['Early-stage Breast Cancer', 'Hormone Receptor Positive Tumor']}, 'referencesModule': {'references': [{'pmid': '26153859', 'type': 'BACKGROUND', 'citation': "Mohammed H, Russell IA, Stark R, Rueda OM, Hickey TE, Tarulli GA, Serandour AA, Birrell SN, Bruna A, Saadi A, Menon S, Hadfield J, Pugh M, Raj GV, Brown GD, D'Santos C, Robinson JL, Silva G, Launchbury R, Perou CM, Stingl J, Caldas C, Tilley WD, Carroll JS. Progesterone receptor modulates ERalpha action in breast cancer. Nature. 2015 Jul 16;523(7560):313-7. doi: 10.1038/nature14583. Epub 2015 Jul 8."}, {'pmid': '27729416', 'type': 'BACKGROUND', 'citation': 'Lim E, Tarulli G, Portman N, Hickey TE, Tilley WD, Palmieri C. Pushing estrogen receptor around in breast cancer. Endocr Relat Cancer. 2016 Dec;23(12):T227-T241. doi: 10.1530/ERC-16-0427. Epub 2016 Oct 11.'}]}, 'descriptionModule': {'briefSummary': 'A phase II randomised, open label study of pre-operative endocrine therapy with \\& without prometrium in postmenopausal women with early stage breast hormone receptor positive (HR+) human epidermal receptor 2 negative (HER2-) breast cancer.', 'detailedDescription': 'There is bidirectional interplay between the progesterone receptor (PR) and oestrogen receptor (ER) in human breast cancers. There is evidence for a reprogramming of ER chromatin binding sites with 470 genes differentially regulated by dual treatment with estrogen plus progestogen compared to estrogen alone in breast cancer cell lines. Functionally, there was an additive anti-cancer effect with the addition of natural progesterone to endocrine therapy in preclinical breast cancer models.\n\nThis is a phase II multi-site, randomised, open-label, three-arm, study in 200 postmenopausal women with early-stage ER+, PR+, HER2-negative breast cancer. Eligible patients will be randomised (1:1:1) to receive 14 days of intervention with either letrozole 2.5mg PO daily (arm 1), letrozole 2.5mg + prometrium 300mg PO daily (arm 2) or tamoxifen 20mg + prometrium 300mg PO daily (arm 3), between diagnosis of breast cancer and definitive surgery.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Histologically confirmed ER+ and PR+ breast cancer (defined as ≥10% positive staining cells)\n2. Histologically confirmed HER2-negative breast cancer (defined as IHC 0-1 and/or FISH/CISH \\<2.2)\n3. Tumour size ≥1 cm as measured by ultrasound and/or mammogram\n4. Ability to understand all patient information and informed-consent documents, written informed consent to participate in the trial, and to avail tissue and blood samples for research\n5. Aged 18 years or older\n\nExclusion Criteria:\n\n1. Women currently on hormone therapies, including hormone replacement therapy and oral contraceptive pill\n2. Locally advanced/inoperable and inflammatory breast cancer\n3. Planned for a mastectomy (due to increased risk of venous thromboembolism)\n4. Clinical evidence of metastatic disease\n5. Patients treated with other preoperative systemic therapies\n6. Nut allergy (prometrium contains peanut oil)\n7. Prior history of uterine cancer, deep vein thrombosis, pulmonary embolism or clotting disorder\n8. Women who are pregnant or breast-feeding'}, 'identificationModule': {'nctId': 'NCT03906669', 'acronym': 'WinPro', 'briefTitle': 'A Window of Opportunity Study of Pre-operative Endocrine Therapy With and Without Prometrium in Postmenopausal Women With Early Stage Breast Hormone Receptor Positive (HR+) Human Epidermal Receptor 2 Negative (HER2-) Breast Cancer.', 'organization': {'class': 'OTHER', 'fullName': "St Vincent's Hospital"}, 'officialTitle': 'A Window of Opportunity Study of Endocrine Therapy With and Without Prometrium in Postmenopausal Women With Early Stage Hormone Receptor-positive Breast Cancer.', 'orgStudyIdInfo': {'id': 'ACTRN1261000928213'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Letrozole', 'description': 'Letrozole 2.5mg PO daily for 14 days between diagnosis of breast cancer and definite surgery', 'interventionNames': ['Drug: Letrozole']}, {'type': 'EXPERIMENTAL', 'label': 'Letrozole and Prometrium', 'description': 'Letrozole 2.5mg PO daily and Prometrium 300mg PO daily for 14 days between diagnosis of breast cancer and definite surgery', 'interventionNames': ['Drug: Letrozole and Prometrium']}, {'type': 'EXPERIMENTAL', 'label': 'Tamoxifen and Prometrium', 'description': 'Tamoxifen 20mg PO daily and Prometrium 300mg PO daily for 14 days between diagnosis of breast cancer and definite surgery', 'interventionNames': ['Drug: Tamoxifen and Prometrium']}], 'interventions': [{'name': 'Letrozole', 'type': 'DRUG', 'description': 'PO daily for 14 days', 'armGroupLabels': ['Letrozole']}, {'name': 'Letrozole and Prometrium', 'type': 'DRUG', 'description': 'PO daily for 14 days', 'armGroupLabels': ['Letrozole and Prometrium']}, {'name': 'Tamoxifen and Prometrium', 'type': 'DRUG', 'description': 'PO daily for 14 days', 'armGroupLabels': ['Tamoxifen and Prometrium']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2010', 'city': 'Sydney', 'state': 'New South Wales', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Robert Kent', 'role': 'CONTACT', 'email': 'svhs.cancerresearch@svha.org.au', 'phone': '+61293555611'}], 'facility': "St Vincent's Hospital", 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}], 'centralContacts': [{'name': 'Robert Kent', 'role': 'CONTACT', 'email': 'SVHS.CancerResearch@svha.org.au', 'phone': '+61293555611'}], 'overallOfficials': [{'name': 'Elgene Lim, MBBS FRACP PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Garvan Research Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "St Vincent's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Elgene Lim', 'investigatorAffiliation': "St Vincent's Hospital, Sydney"}}}}