Breast Cancer Clinical Trial
Study to Evaluate the Safety and Efficacy of NKTR-102 in Patients With Metastatic or Locally Advanced Breast Cancer
Summary
This is a multicenter, open-label, two-arm, 2-stage, Phase 2 study of NKTR-102 in patients with metastatic or locally advanced breast cancer whose disease has failed prior taxane-based treatment in the metastatic setting.
Patients will be randomized 1:1 into one of two treatment arms. NKTR 102 will be administered at a dose level of 145 mg/m2 in both arms. In Arm A, NKTR-102 will be given on a q14d schedule. In Arm B, NKTR-102 will be given on a q21d schedule. Approximately 70 patients may be evaluated in this study with approximately 35 patients enrolled in each treatment arm.
Eligibility Criteria
Inclusion Criteria:
Inoperable metastatic or locally advanced breast cancer
No more than 2 prior chemotherapy regimens given in a metastatic or locally advanced setting and prior treatment in the metastatic setting must have included a taxane
Exclusion Criteria:
Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to Day 1 of Cycle 1
Patients who have had any major surgery within 4 weeks prior to Day 1 of Cycle or minor surgery within 2 weeks prior to Day 1 of Cycle 1
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There are 19 Locations for this study
Los Angeles California, 90089, United States
Rancho Mirage California, 92270, United States
Stockton California, 95204, United States
Jacksonville Florida, 32224, United States
Louisville Kentucky, 40207, United States
Rochester Minnesota, 55905, United States
East Providence Rhode Island, 02915, United States
Charlottesville Virginia, 22908, United States
Bruxelles , 2-2-5, Belgium
Edegem , 2650, Belgium
Gent , 9000, Belgium
Liege , 4000, Belgium
Wilrijk , 2610, Belgium
Bebington , CH63 , United Kingdom
Cardiff , CH14 , United Kingdom
Glasgow , G12 O, United Kingdom
Leed , LS97T, United Kingdom
Nottingham , NG5 1, United Kingdom
Sheffield , S10 2, United Kingdom
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