Ignite Creation Date:
2025-12-24 @ 10:53 PM
Ignite Modification Date:
2025-12-28 @ 10:09 AM
Study NCT ID:
NCT00123669
Status:
COMPLETED
Last Update Posted:
2020-07-22
First Post:
2005-07-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Primary Progesterone Therapy for Operable Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1997-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-05-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-21', 'studyFirstSubmitDate': '2005-07-21', 'studyFirstSubmitQcDate': '2005-07-21', 'lastUpdatePostDateStruct': {'date': '2020-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-07-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-05-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To test the effect of primary progesterone in operable breast cancer on overall and disease free survival at 5 years', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cancer of the Breast', 'Neoplasm'], 'conditions': ['Breast Neoplasms']}, 'referencesModule': {'references': [{'pmid': '8018400', 'type': 'BACKGROUND', 'citation': 'Badwe RA, Wang DY, Gregory WM, Fentiman IS, Chaudary MA, Smith P, Richards MA, Rubens RD. Serum progesterone at the time of surgery and survival in women with premenopausal operable breast cancer. Eur J Cancer. 1994;30A(4):445-8. doi: 10.1016/0959-8049(94)90415-4.'}, {'pmid': '1674070', 'type': 'BACKGROUND', 'citation': 'Badwe RA, Gregory WM, Chaudary MA, Richards MA, Bentley AE, Rubens RD, Fentiman IS. Timing of surgery during menstrual cycle and survival of premenopausal women with operable breast cancer. Lancet. 1991 May 25;337(8752):1261-4. doi: 10.1016/0140-6736(91)92927-t.'}, {'pmid': '8652239', 'type': 'BACKGROUND', 'citation': 'Badwe RA, Bettelheim R, Millis RR, Gregory W, Richards MA, Fentiman IS. Cyclical tumour variations in premenopausal women with early breast cancer. Eur J Cancer. 1995 Dec;31A(13-14):2181-4. doi: 10.1016/0959-8049(95)00301-0.'}, {'pmid': '10572550', 'type': 'BACKGROUND', 'citation': 'Badwe RA, Mittra I, Havaldar R. Timing of surgery with regard to the menstrual cycle in women with primary breast cancer. Surg Clin North Am. 1999 Oct;79(5):1047-59. doi: 10.1016/s0039-6109(05)70060-8.'}, {'pmid': '7914322', 'type': 'BACKGROUND', 'citation': 'Badwe RA, Hawaldar RW. Effect of menstrual phase on surgical treatment of breast cancer. Lancet. 1994 Aug 6;344(8919):404. No abstract available.'}, {'pmid': '8172788', 'type': 'BACKGROUND', 'citation': 'Badwe RA, Juvekar RR. Timing of breast cancer surgery during the menstrual cycle. Ann Oncol. 1994 Jan;5(1):29-31. doi: 10.1093/oxfordjournals.annonc.a058682. No abstract available.'}, {'pmid': '21670457', 'type': 'DERIVED', 'citation': 'Badwe R, Hawaldar R, Parmar V, Nadkarni M, Shet T, Desai S, Gupta S, Jalali R, Vanmali V, Dikshit R, Mittra I. Single-injection depot progesterone before surgery and survival in women with operable breast cancer: a randomized controlled trial. J Clin Oncol. 2011 Jul 20;29(21):2845-51. doi: 10.1200/JCO.2010.33.0738. Epub 2011 Jun 13.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test the effect of primary progesterone on overall and disease free survival in women with operable breast cancer. The study addresses two issues related to breast cancer surgery:\n\n* Circulating progesterone at the time of surgery might counteract the detrimental effect of estrogen on survival of women with operable breast cancer.\n* Events at the time of surgery may have an impact on the natural history of breast cancer', 'detailedDescription': 'This protocol addresses the issue of pre-operative hormone manipulation in women with operable breast cancer. The study has been designed after careful review of literature to assess the effect of unopposed oestrogen at the time of surgery and collect evidence that events at the time of surgery may have impact on the long-term survival of breast cancer patients. The meta-analysis of 37 studies on timing of surgery during the menstrual cycle showed a 15% + 3 improvement in survival for women who had undergone surgery during the luteal phase of their menstrual cycle. Three of the 37 studies where progesterone levels were estimated at the time of surgery showed 52% + 26 improvement in survival when circulating progesterone were \\> 1.5 ng/ml. The study aims to produce luteal milieu by injecting Hydroxy- progesterone 500 mg IM at the time of surgery. The timing of administration of progesterone in the neo-adjuvant setting is decided after collating data from large data-bases and randomised trials of screening suggesting that events at the time of surgery may alter the behavior of micro-metastases.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Unilateral operable palpable breast cancer\n\nExclusion Criteria:\n\n* Previous history of excision biopsy of the primary tumour\n* History of other epithelial/mesenchymal malignant tumours except basal cell carcinoma/squamous cell carcinoma (BCC/SCC) of skin'}, 'identificationModule': {'nctId': 'NCT00123669', 'briefTitle': 'Primary Progesterone Therapy for Operable Breast Cancer', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Tata Memorial Hospital'}, 'officialTitle': 'The Primary Progesterone Therapy for Operable Breast Cancer : A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'No. SP/SO/B29/2000'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Patient will not receive Inj Progesterone 500 mg'}, {'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'An intramuscular injection of 500mg depot hydroxy-progesterone 5-14 days prior to surgery.', 'interventionNames': ['Drug: 500 mg of depot hydroxy-progesterone']}], 'interventions': [{'name': '500 mg of depot hydroxy-progesterone', 'type': 'DRUG', 'description': 'An intramuscular injection of 500 mg of depot hydroxy-progesterone 5 to 15 days prior to surgery.', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400012', 'city': 'Mumbai', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Tata Memorial Hospital', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}], 'overallOfficials': [{'name': 'Rajendra A Badwe, M.S.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor & Head, Department of Surgical Oncology, Chief Breast Unit'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tata Memorial Hospital', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Ministry of Science and Technology, India', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Dr Rajendra A. Badwe', 'investigatorAffiliation': 'Tata Memorial Centre'}}}}