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 10 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

暂无简介。

•*An eligible patient is an adult female with histologically or cytologically
•confirmed carcinoma of the breast. Patients may have either measurable
•by RECIST v1.1 or non-measurable disease, locally recurrent or metastatic disease that is not resectable or amenable to curative treatment.
•Prior therapy (administered in the neoadjuvant, adjuvant and/or metastatic
•setting) must include an anthracycline (unless not medically appropriate or
•contraindicated for the patient), a taxane, and Xeloda® (capecitabine). Patients
•must have received a minimum of two and a maximum of five prior cytotoxic
•chemotherapy regimens for the treatment of breast cancer, with the last dose
•administered within 6 months of the date of consent for this trial. Patients must
•have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
•1 with adequate organ function. Patients with brain metastases may be eligible,
•provided local therapy was completed and use of corticosteroids for this
•indication discontinued for at least 3 weeks prior to randomization with stable
•brain metastases (by symptoms and imaging).
•The complete list of inclusion and exclusion criteria is provided in Section 5.0 .

•*Patient who have had a last dose of IV chemotherapy within 21 days, last dose of oral chemotherapy, radiotherapy within 14 days, biological therapy with 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 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