The BEACON Study (Breast Cancer Outcomes With NKTR-102)
Study Status
Open to Enrollment
Study Description
Full protocol 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
This clinical trial is for women with locally recurrent or metastatic breast cancer that was previously treated with an anthracycline, a taxane, and capecitabine.
The purpose of the study is to test how well women with breast cancer respond to treatment with the experimental drug NKTR-102, compared to standard treatments for breast cancer. The study will also look at the side effects of the study drug and examine how long NKTR-102 stays in a patient’s blood.
Study participants will be randomly assigned to one of two study arms.
- Arm A: participants will receive NKTR-102 via infusion on Day 1 of each 21 day cycle.
- Arm B: participants will receive one of seven standard of care treatment options available at the study center. The choice of treatment in Arm B will be made after discussions with your doctor. Depending on which drug is chosen by you and your doctor, cycles in Arm B will be either 21 days or 28 days.
The study will take about 38 months to complete. The amount of time on study depends on how well a participant responds to study treatment.
Disease Status and/or Stage
Locally Recurrent or Metastatic Breast Cancer Previously Treated with Cytotoxic Chemotherapy
Sponsor
Nektar Therapeutics
Key Eligibility
- Women age 18 and older
- Diagnosed with breast cancer
- Locally recurrent or metastatic disease
- Prior therapy must have included anthracycline, a taxane, and Xeloda; must have receiveda minimum of 2 and maximum of 5 prior cyotoxic chemotherapy regimens
- Detailed eligibility reviewed when you contact the study team
Principal Investigator
Contact
- Marta Cobham
- (212) 821-0780
- [email protected]
- Weill Cornell Breast Center
- (212) 821-0644
Healthy Volunteers
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Contact Us
For general inquiries, or if you need assistance finding a study, please contact:
Robert Hagerty
Subject Recruitment Manager
Tel: (646) 962-9340
[email protected]