Ignite Creation Date:
2025-12-24 @ 5:37 PM
Ignite Modification Date:
2026-02-26 @ 12:37 AM
Study NCT ID:
NCT02142868
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2018-12-21
First Post:
2014-05-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Expanded Access Study Of Palbociclib (PD-0332991) In Combination With Letrozole As Treatment Of Post-Menopausal Women With HR-Positive, Her2-Negative Advanced Breast Cancer For Whom Letrozole Therapy Is Deemed Appropriate
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C500026', 'term': 'palbociclib'}, {'id': 'D000077289', 'term': 'Letrozole'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS', 'expandedAccessTypes': {'individual': True}}, 'statusModule': {'overallStatus': 'NO_LONGER_AVAILABLE', 'statusVerifiedDate': '2018-12', 'lastUpdateSubmitDate': '2018-12-20', 'studyFirstSubmitDate': '2014-05-16', 'studyFirstSubmitQcDate': '2014-05-16', 'lastUpdatePostDateStruct': {'date': '2018-12-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-05-20', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Expanded Access', 'Advanced Breast Cancer'], 'conditions': ['Advanced Breast Cancer (Female)']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'To provide access to palbociclib to post-menopausal women with HR-positive, HER2-negative advanced breast cancer who are deemed appropriate for letrozole therapy (Canada: first-line patients only).', 'detailedDescription': 'This study is currently available in Canada only.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Post-menopausal women 18 years of age or above with proven diagnosis of advanced adenocarcinoma of the breast (locoregionally recurrent or metastatic disease)\n* ER-positive and/or PR-positive tumor based on local laboratory results\n* HER2-negative tumor based on local laboratory results\n* Patients must be appropriate candidates for letrozole therapy (Canada: first-line patients only)\n\nExclusion Criteria:\n\n* Patients who have previously participated in a palbociclib trial or who have received prior treatment with any CDK inhibitor'}, 'identificationModule': {'nctId': 'NCT02142868', 'briefTitle': 'Expanded Access Study Of Palbociclib (PD-0332991) In Combination With Letrozole As Treatment Of Post-Menopausal Women With HR-Positive, Her2-Negative Advanced Breast Cancer For Whom Letrozole Therapy Is Deemed Appropriate', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'AN EXPANDED ACCESS STUDY OF PALBOCICLIB IN COMBINATION WITH LETROZOLE AS TREATMENT OF POST-MENOPAUSAL WOMEN WITH HORMONE RECEPTOR POSITIVE, HER2 NEGATIVE ADVANCED BREAST CANCER FOR WHOM LETROZOLE THERAPY IS DEEMED APPROPRIATE', 'orgStudyIdInfo': {'id': 'A5481034'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Palbociclib', 'type': 'DRUG', 'otherNames': ['Ibrance'], 'description': 'Palbociclib will be administered orally once a day at 125 mg/day for 21 days followed by 7 days off treatment for each 28-day cycle (Schedule 3/1)'}, {'name': 'Letrozole', 'type': 'DRUG', 'otherNames': ['Femara'], 'description': 'Letrozole will be administered orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '93309', 'city': 'Bakersfield', 'state': 'California', 'country': 'United States', 'facility': 'CBCC Global Research, Inc. at Comprehensive Blood & Cancer Center Research Center', 'geoPoint': {'lat': 35.37329, 'lon': -119.01871}}, {'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'MedStar Georgetown University Hospital', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Washington Cancer Institute at MedStar Washington Hospital Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '30096', 'city': 'Duluth', 'state': 'Georgia', 'country': 'United States', 'facility': 'Gwinnett Hospital System Inc. -d/b/a - The Center for Cancer Care', 'geoPoint': {'lat': 34.00288, 'lon': -84.14464}}, {'zip': '30046', 'city': 'Lawrenceville', 'state': 'Georgia', 'country': 'United States', 'facility': 'Gwinnett Hospital System Inc. -d/b/a - The Center for Cancer Care', 'geoPoint': {'lat': 33.95621, 'lon': -83.98796}}, {'zip': '60657', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Presence Saint Joseph Hospital', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60014', 'city': 'Crystal Lake', 'state': 'Illinois', 'country': 'United States', 'facility': 'North Shore Oncology-Hematology Associates, Ltd.', 'geoPoint': {'lat': 42.24113, 'lon': -88.3162}}, {'zip': '60048', 'city': 'Libertyville', 'state': 'Illinois', 'country': 'United States', 'facility': 'North Shore Oncology-Hematology Associates, Ltd.', 'geoPoint': {'lat': 42.28308, 'lon': -87.95313}}, {'zip': '60062', 'city': 'Northbrook', 'state': 'Illinois', 'country': 'United States', 'facility': 'Presence Medical Group Hematology Oncology', 'geoPoint': {'lat': 42.12753, 'lon': -87.82895}}, {'zip': '61615', 'city': 'Peoria', 'state': 'Illinois', 'country': 'United States', 'facility': 'Illinois CancerCare, P.C.', 'geoPoint': {'lat': 40.69365, 'lon': -89.58899}}, {'zip': '60077', 'city': 'Skokie', 'state': 'Illinois', 'country': 'United States', 'facility': 'Presence Infusion Care - 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