The BEACON Study (Breast Cancer Outcomes With NKTR-102)

Not Recruiting

Trial ID: NCT01492101


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.

Official Title

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

Stanford Investigator(s)

Mark Pegram

Susy Yuan-Huey Hung Professor


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

   - 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

   - Patients with significant cardiovascular impairment.


drug: NKTR-102

drug: Treatment of Physician's Choice (TPC)

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305

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