Ignite Creation Date:
2025-12-24 @ 11:53 AM
Ignite Modification Date:
2026-01-13 @ 11:33 AM
Study NCT ID:
NCT00232661
Status:
COMPLETED
Last Update Posted:
2010-02-03
First Post:
2005-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PROACT - Pre-Operative Arimidex Compared To Tamoxifen
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': 'D000077384', 'term': 'Anastrozole'}, {'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': '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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 452}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-02', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-02-02', 'studyFirstSubmitDate': '2005-09-30', 'studyFirstSubmitQcDate': '2005-09-30', 'lastUpdatePostDateStruct': {'date': '2010-02-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-10-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective tumour response', 'timeFrame': 'Assessed at 3 months'}], 'secondaryOutcomes': [{'measure': 'Pathological response', 'timeFrame': 'Assessed at 3 months'}, {'measure': 'Extent of breast surgery', 'timeFrame': 'Assessed at 3 months'}, {'measure': 'Extent of axillary down-staging', 'timeFrame': 'Assessed at 3 months'}, {'measure': 'Clinical ultrasound response versus clinical caliper response', 'timeFrame': 'Assessed at 3 months'}, {'measure': 'Safety', 'timeFrame': 'Assessed up to 5 years + 30 days'}, {'measure': 'Complications due to surgery', 'timeFrame': 'Assessed up to 30 days post-surgery'}, {'measure': 'Health economics outcomes', 'timeFrame': 'Assessed up to 30 days post-surgery'}, {'measure': 'Quality of Life assessments', 'timeFrame': 'Assessed at 3 months'}, {'measure': 'Effect of ethnicity with respect to baseline patient and tumour characteristics, safety and objective tumour response rate', 'timeFrame': 'Assessed up to 5 years + 30 days'}, {'measure': 'Recurrence-free survival and survival', 'timeFrame': 'Assessed up to 5 years'}]}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '16598749', 'type': 'RESULT', 'citation': 'Cataliotti L, Buzdar AU, Noguchi S, Bines J, Takatsuka Y, Petrakova K, Dube P, de Oliveira CT. Comparison of anastrozole versus tamoxifen as preoperative therapy in postmenopausal women with hormone receptor-positive breast cancer: the Pre-Operative "Arimidex" Compared to Tamoxifen (PROACT) trial. Cancer. 2006 May 15;106(10):2095-103. doi: 10.1002/cncr.21872.'}, {'pmid': '22136317', 'type': 'DERIVED', 'citation': 'Fujiwara Y, Takatsuka Y, Imoto S, Inaji H, Ikeda T, Akiyama F, Tamura M, Miyoshi K, Iwata H, Mitsuyama S, Noguchi S. Outcomes of Japanese breast cancer patients treated with pre-operative and post-operative anastrozole or tamoxifen. Cancer Sci. 2012 Mar;103(3):491-6. doi: 10.1111/j.1349-7006.2011.02171.x. Epub 2012 Jan 13.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare tamoxifen, versus a newer treatment, ARIMIDEX, which we already know to be well tolerated. The main objectives of this research study are to see whether using these drugs will shrink down tumours before surgery and to see if any shrinkage in the tumour affects the extent of surgery that is required.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Operable or potentially operable breast cancer\n* Invasive breast cancer proven to be hormone-sensitive (ER+/PR+)\n* Patients who might benefit from endocrine treatment prior to surgery\n* Postmenopausal\n* Signed written informed consent\n\nExclusion Criteria:\n\n* Inoperable breast cancer\n* Patient unwilling to undergo surgery\n* Any reason why the patient may not be able to conform to study requirements\n* Any previous treatment for breast cancer\n* Previous Tamoxifen use as a part of breast cancer prevention trials\n* Not willing to stop taking drugs that affect sex-hormones such as HRT\n* Previous history of breast cancer\n* Previous history of invasive malignancy within the last 10 years\n* Any other severe disease that may prevent surgery, place the patient at risk, or influence the study results\n* Treatment with an experimental drug within the last 3 months\n* Risk of transmitting HIV, Hepatitis B or C'}, 'identificationModule': {'nctId': 'NCT00232661', 'briefTitle': 'PROACT - Pre-Operative Arimidex Compared To Tamoxifen', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Randomised, Double-blind, Study Comparing ARIMIDEX™ With NOLVADEX™ as Neo-adjuvant and Adjuvant Treatment in Post-menopausal Women With Large Operable (T2 (≥3cm), T3, N0-2, M0) or Potentially-operable, Locally Advanced (T4b, N0-2, M0), ER+ and/or PR+ Breast Cancer.', 'orgStudyIdInfo': {'id': '1033IL/0039'}, 'secondaryIdInfos': [{'id': 'D5395C00039'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'ARIMIDEX (anastrazole)', 'type': 'DRUG'}, {'name': 'NOLVADEX (tamoxifen)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Santa Rosa', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 38.44047, 'lon': -122.71443}}, {'city': 'New Britain', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 41.66121, 'lon': -72.77954}}, {'city': 'Torrington', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 41.80065, 'lon': -73.12122}}, {'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'city': 'Mason City', 'state': 'Iowa', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 43.15357, 'lon': -93.20104}}, {'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, 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