The BEACON Study (Breast Cancer Outcomes With NKTR-102)
Condition: Locally Recurrent Breast Cancer; Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: NKTR-102; Treatment of Physician's Choice (TPC)
Intervention description: 145 mg/m2 NKTR-102 will be delivered q21day as a 90-minute intravenous (IV) infusion on day 1 of each treatment cycle.; One of the following Treatment of Physician Choice will be administered per standard of care:
eribulin, ixabepilone, vinorelbine, gemcitabine, paclitaxel, docetaxel, or nab-paclitaxel
Intervention MeSH terms: Etirinotecan pegol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 852.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The study is designed as an open-label, randomized, parallel, two arm, multicenter,
      international Phase 3 study in patients with recurrent or metastatic breast cancer previously
      treated with cytotoxic chemotherapy regimens.

      The primary study objective is to compare overall survival of patients who receive NKTR-102
      given once every 21 days to patients who receive treatment of Physician's Choice selected
      from a list of seven single-agent intravenous therapies.
    

Eligibility criteria:

        Inclusion Criteria (major highlights):

          -  Patient is an adult female with histologically or cytologically confirmed carcinoma of
             the breast for whom single-agent cytotoxic chemotherapy is indicated

          -  Patient can have either measurable or non-measurable disease by RECIST.

          -  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.

          -  Patient has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

          -  Adequate hematopoietic, liver and kidney functions.

        Exclusion Criteria (major highlights):

          -  Patient with chemotherapy within 21 days, radiotherapy within 14 days, biological
             therapy with 14 days, hormonal therapy within 7 days and investigational therapy
             within 21 days prior to randomization.

          -  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.