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




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 (USON 11-PIR-11)

Study Description:

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.

Inclusion Criteria:

» 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:

» 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.

Locations:


Texas Oncology - Baylor Charles A. Sammons Cancer Center
3410 Worth Street
Dallas , TX 75246

Texas Oncology - Baylor All Saints Medical Center at Fort Worth
1400 Eighth Avenue
Fort Worth , TX 76104

Lead Principal Investigator:

Joyce O'Shaughnessy, MD (Dallas); Sanjay Oommen, MD (Fort Worth)



For further information regarding this study, please contact the Office of Clinical Oncology Research Coordination at 214-818-8472 or via email at cancer.trials@baylorhealth.edu.

Last update: December 31, 2012
† Baylor Research Institute and Texas Oncology are not affiliated. Each reviews, approves, and conducts clinical trials independently. Their clinical trials are listed together on this website for the convenience of patients.