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Brief Title: A Study of Etirinotecan Pegol (NKTR-102) Versus Treatment of Physician's Choice (TPC) in Patients With Metastatic Breast Cancer Who Have Stable Brain Metastases and Have Been Previously Treated With an Anthracycline, a Taxane, and Capecitabine
Official Title: A Phase 3 Open-Label, Randomized, Multicenter Study of NKTR-102 Versus Treatment of Physician's Choice (TPC) in Patients With Metastatic Breast Cancer Who Have Stable Brain Metastases and Have Been Previously Treated With an Anthracycline, a Taxane, and Capecitabine
Study ID: NCT02915744
Brief Summary: This is an open-label, randomized, active comparator, multicenter, international Phase 3 study of NKTR-102 versus TPC in patients with metastatic breast cancer who have stable brain metastases and have been previously treated with an anthracycline, a taxane, and capecitabine in either the adjuvant or metastatic setting (prior anthracycline may be omitted if medically appropriate or contraindicated for the patient).
Detailed Description: This is an open-label, randomized, active comparator, multicenter, international Phase 3 study of NKTR-102 versus TPC in patients with metastatic breast cancer who have stable brain metastases and have been previously treated with an anthracycline, a taxane, and capecitabine in either the adjuvant or metastatic setting (prior anthracycline may be omitted if medically appropriate or contraindicated for the patient). In Group A, NKTR-102 will be administered at a dose level of 145 mg/m2 on a q21d schedule as a 90-minute intravenous (IV) infusion on Day 1 of each treatment cycle. In Group B, TPC will be administered per standard of care. Patients randomized to TPC will receive single-agent IV chemotherapy, limited to choice of one of the following 7 agents: eribulin, ixabepilone, vinorelbine, gemcitabine, paclitaxel, docetaxel, or nab-paclitaxel. This study will randomize approximately 220 patients using a 1:1 randomization ratio and stratification based on geographic region, tumor receptor status, and Eastern Cooperative Oncology Group (ECOG) status. At Screening, the Investigator must determine which TPC will be offered to the patient. Data will be collected on subsequent anticancer therapies in both treatment groups from the time patients come off the study treatment until the time of primary data analysis for Overall Survival (OS). An independent data monitoring committee (DMC) will assess interim safety and efficacy data and determine final number of death events needed to provide 80% conditional power based on the zone adaptive design.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Investigator Site - Tucson, Tucson, Arizona, United States
Investigator Site - Orange, Orange, California, United States
Investigator Site - San Francisco, San Francisco, California, United States
Investigator Site - Miami, Miami, Florida, United States
Investigator Site - Plantation, Plantation, Florida, United States
Investigator Site - West Palm Beach, West Palm Beach, Florida, United States
Investigator Site - Athens, Athens, Georgia, United States
Investigator Site - Baltimore, Baltimore, Maryland, United States
Investigator Site - Boston, Boston, Massachusetts, United States
Investigator Site - Minneapolis, Minneapolis, Minnesota, United States
Investigator Site - Saint Louis, Saint Louis, Missouri, United States
Investigator Site - New York, New York, New York, United States
Investigator Site - Chapel Hill, Chapel Hill, North Carolina, United States
Investigator Site - Columbus, Columbus, Ohio, United States
Investigator Site - Germantown, Germantown, Tennessee, United States
Investigator Site - Fort Worth, Fort Worth, Texas, United States
Investigator Site - Houston, Houston, Texas, United States
Investigator Site - Salt Lake City, Salt Lake City, Utah, United States
Investigator Site - Seattle, Seattle, Washington, United States
Investigatory Site - Albury, Albury, New South Wales, Australia
Investigator Site - Darlinghurst, Darlinghurst, New South Wales, Australia
Investigator Site - Wollongong, Wollongong, New South Wales, Australia
Investigator Site - Subiaco, Subiaco, Western Australia, Australia
Investigator Site - Box Hill, Box Hill, , Australia
Investigator Site - Nedlands, Nedlands, , Australia
Investigator Site - Brussels, Brussels, , Belgium
Investigator Site - Brussels, Brussels, , Belgium
Investigator Site - Brussels, Brussels, , Belgium
Investigator Site - Charleroi, Charleroi, , Belgium
Investigator Site - Edegem, Edegem, , Belgium
Investigator Site - Liege, Liège, , Belgium
Investigator Site - Woluwe- Saint-Lambert, Woluwe-Saint-Lambert, , Belgium
Investigator Site - Montreal, Montréal, Quebec, Canada
Investigator Site - Le Mans, Le Mans, , France
Investigator Site - Nimes, Nîmes, , France
Investigator Site - Paris, Paris, , France
Investigator Site - Rennes, Rennes, , France
Investigator Site - Rouen, Rouen, , France
Investigator Site - Strasbourg, Strasbourg, , France
Investigator Site - Beersheba, Beersheba, , Israel
Investigator Site - Haifa, Haifa, , Israel
Investigator Site - Tel Aviv, Tel Aviv, , Israel
Investigator Site - Milano, Milano, , Italy
Investigator Site - Milan, Milan, , Italy
Investigator Site - Napoli, Napoli, , Italy
Investigator Site - Roma, Roma, , Italy
Investigator Site - Lisboa, Lisboa, , Portugal
Investigator Site - Porto, Porto, , Portugal
Investigator Site - Barcelona, Barcelona, , Spain
Investigator Site - Barcelona, Barcelona, , Spain
Investigator Site - Madrid, Madrid, , Spain
Investigator Site - Santa Cruz de Tenerife, Santa Cruz de Tenerife, , Spain
Investigator Site - Sevilla, Sevilla, , Spain
Investigator Site - Bradford, Bradford, , United Kingdom
Investigator Site - Manchester, Manchester, , United Kingdom
Investigator Site - Nottingham, Nottingham, , United Kingdom