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Spots Global Cancer Trial Database for 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

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Trial Identification

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

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

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