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Patients may have either measurable or non-measurable disease according to RECIST version 1.1.\n* Patients must have a history of brain metastases that are non-progressing.\n* For triple-negative breast cancer, a minimum of 1 prior cytotoxic chemotherapy regimen must have been administered for the indication of metastatic disease.Depending on receptor status, 1 or 2 prior cytotoxic regimens are required prior to enrollment in this trial; hormonal and\u002For human epidermal growth factor receptor 2 (HER2) -targeted agents may be required.\n* Have had prior therapy (administered in the neoadjuvant, adjuvant, and\u002For metastatic setting) with an anthracycline, a taxane, and capecitabine (prior anthracycline can be omitted if not medically appropriate or contraindicated for the patient).\n* Last dose of anticancer therapy must have been administered within 6 months of the date of randomization into this study.\n* All anticancer- and radiation therapy-related toxicities must be completely resolved or downgraded to Grade 1 or less (neuropathy may be Grade 2 or less).\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Demonstrate adequate organ function obtained within 14 days prior to randomization and analyzed by the central laboratory.\n* Women of childbearing potential (WCBP) must agree to use highly effective methods of birth control throughout the duration of the study until 6 months following the last dose of study drug.\n* Males with female partners of child-bearing potential must agree to use a barrier contraception (e.g., condom with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository) throughout the duration of the study until 6 months following the last dose of study drug; in addition to their female partner using either an intrauterine device or hormonal contraception and continuing until 6 months following the last dose of study drug. Male patients should not donate sperm until 6 months following the last dose of study drug.\n\nExclusion Criteria:\n\n* Last dose of anticancer therapy (including HER2-targeted therapy) within 14 days prior to randomization.\n* High-dose chemotherapy followed by stem cell transplantation (autologous or allogeneic).\n* Major surgery within 28 days prior to randomization.\n* Concomitant use of any anticancer therapy or use of any investigational agent(s).\n* Received prior treatment for cancer with a camptothecin-derived agent.\n* Lesions on imaging, by cerebrospinal fluid or with neurological findings that are consistent with leptomeningeal disease or meningeal carcinomatosis.\n* Chronic or acute GI disorders resulting in diarrhea of any severity grade.\n* Patients who are pregnant or lactating, plan to get pregnant, or have a positive serum pregnancy test prior to randomization.\n* Enzyme-inducing anti-epileptic drugs (EIAEDs) within 14 days of randomization.\n* Hepatitis B or C, tuberculosis, or HIV.\n* Cirrhosis.\n* Prior malignancy (other than breast cancer) unless diagnosed and definitively treated more than 5 years prior to randomization.\n* Daily use of oxygen supplementation.\n* Significant known cardiovascular impairment.\n* Prior treatment with NKTR-102.\n* Psychiatric illness, social situation, or geographical situation that preclude informed consent or limit compliance.\n* Known intolerance or hypersensitivity to any of the products used in this study or their excipients.\n* For patients selecting vinorelbine or gemcitabine as the TPC agent, patients may not receive yellow fever vaccine in the 28 days prior to randomization.",false,"ALL","18 Years",{"count":595,"type":596},178,"ACTUAL","INTERVENTIONAL",[599],"PHASE3","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).",[602,603],"Metastasis","Breast Cancer",[605,606],"Breast Cancer Brain Metastases (BCBM)","Carcinoma","COMPLETED","2023-04-10",{"date":610,"type":596},"2023-04-14",{"date":612,"type":29},"2016-11",{"date":614,"type":596},"2020-07",{"name":5,"class":6},56]