This trial is active, not recruiting.

Conditions locally recurrent breast cancer, metastatic breast cancer
Treatments nktr-102, treatment of physician's choice (tpc)
Phase phase 3
Sponsor Nektar Therapeutics
Start date December 2011
End date December 2016
Trial size 840 participants
Trial identifier NCT01492101, 11-PIR-11


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
145 mg/m2 NKTR-102 will be delivered q21day as a 90 minute intravenous (IV) infusion on day 1 of each treatment cycle.
(Active Comparator)
treatment of physician's choice (tpc)
One of the following Treatment of Physician Choice will be administered per standard of care: eribulin ixabepilone vinorelbine gemcitabine paclitaxel docetaxel or nab-paclitaxel

Primary Outcomes

Overall Survival
time frame: 36 Months

Eligibility Criteria

Female participants at least 18 years old.

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.

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Nektar Therapeutics.