The BEACON Study (BrEAst Cancer Outcomes with NKTR-102): A Phase 3 Open-Label, Randomized, Multicenter Study of NKTR-102 versus Treatment of Physician’s Choice (TPC) in Patients with Locally Recurrent or Metastatic Breast Cancer Previously Treated with an Anthracycline, a Taxane, and Capecitabine - BEACO

ektar Therapeutics0 个研究点目标入组 852 人开始时间: 2012年3月29日最近更新: 2019年6月30日

适应症

试验速览

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•Patient is an adult female with histologically or cytologically confirmed carcinoma of the breast for whom single-agent cytotoxic chemotherapy is indicated. Patients may have either measurable disease by RECIST version 1.1 or nonmeasurable disease.
•Locally recurrent or metastatic disease that is not resectable or amenable to curative
•Patient has received prior therapy (administered in the neoadjuvant, adjuvant and/or metastatic setting) with an anthracycline, a taxane and capecitabine
•Patient has minimum of 2 and a maximum of 5 prior cytotoxic chemotherapy regimens with the last dose administered within 6 months. A minimum of two chemotherapy regimens had to be for locally recurrent and/or metastatic disease. All therapy received prior to a diagnosis of metastatic disease (eg, neoadjuvant, adjuvant or repeated adjuvant therapy following a second resection) is counted as one regimen.Treatment regimens for ipsilateral and/or contralateral recurrent disease (ie, multiple adjuvant therapies) are permitted and all counted as one regimen.
•Patient has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
•Adequate hematopoietic, liver and kidney functions.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 672
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 168

•Patients who have had a last dose of IV chemotherapy within 21 days, last dose of oral cytotoxic chemotherapy, radiotherapy, biological therapy, or investigational therapy within 14 days, or hormonal therapy within 7 days prior to randomization. Patients who have undergone high-dose chemotherapy followed by stem cell transplantation (autologous or allogeneic). Refer to the Study
•Reference Manual for categories of anticancer therapies.
•Patient with any major surgery within 28 days prior to randomization.
•Patient with concurrent use of biologic agents for the treatment of cancer including antibodies or any investigational agent(s).
•Patient with prior treatment for cancer with a camptothecin derivative.
•Patient with chronic or acute GI disorders resulting in diarrhea of any severity grade; patients who are using chronic anti-diarrheal supportive care to control diarrhea in the 28 days prior to randomization.
•Patient received pharmacotherapy for hepatitis B or C, tuberculosis or HIV.
•Patient with known cirrhosis diagnosed with Child-PUGH Class A or higher liver disease.
•Patient with prior malignancy (other than breast cancer) except for non-melanoma skin cancer and carcinoma in situ (of the cervix or bladder), unless diagnosed and definitively treated more than 5 years prior to randomization.
•Patient requiring daily use of oxygen supplementation in the 28 days prior to randomization.
•Patients with significant cardiovascular impairment.

发起方

ektar Therapeutics