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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

Phase 3
18 Years
Open (Enrolling)
Locally Recurrent Breast Cancer, Metastatic Breast Cancer

Thank you

Trial Information

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

Inclusion 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

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Survival

Outcome Description:

To compare overall survival (OS) of patients who received NKTR-102 given once every 21 days (q21d) to patients who received Treatment of Physicians Choice (TPC) selected from the following list of seven single agent intravenous therapies: eribulin, ixabepilone,vinorelbine, gemcitabline, paclitaxel, docetaxel or nab-paclitaxel

Outcome Time Frame:

36 Months

Safety Issue:


Principal Investigator

Robert Medve, MD

Investigator Role:

Study Director

Investigator Affiliation:

Nektar Therapeutics


United States: Food and Drug Administration

Study ID:




Start Date:

December 2011

Completion Date:

Related Keywords:

  • Locally Recurrent Breast Cancer
  • Metastatic Breast Cancer
  • Breast Neoplasms



Mayo Clinic Rochester, Minnesota  55905
Beth Israel Medical Center New York, New York  10003
Virginia Mason Medical Center Seattle, Washington  98111
Cooper University Hospital Camden, New Jersey  08103
Virginia Oncology Associates Newport News, Virginia  23606
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Cancer Centers of the Carolinas Greenville, South Carolina  29605
Wilshire Oncology Medical Group, Inc. Rancho Cucamonga, California  91730
Coborn Cancer Center Saint Cloud, Minnesota  56303
Missouri Cancer Associates Columbia, Missouri  65201
Stanford University School of Medicine Stanford, California  94305-5317
Seattle Cancer Care Alliance Seattle, Washington  98109
University of Minnesota Minneapolis, Minnesota  55455
Rocky Mountain Cancer Centers Thornton, Colorado  80260
Mayo Clinic in Florida Jacksonville, Florida  32224
University of Virginia Charlottesville, Virginia  22908
Cancer Care Northwest Spokane, Washington  99202
University of California San Francisco San Francisco, California  941104206
SUNY Upstate Medical University Syracuse, New York  13210
New York Oncology Hematology, P.C. Albany, New York  12208
Emory University Atlanta, Georgia  30322
Kaiser Permanente Sacramento, California  
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Medical Oncology Associates of Wyoming Valley, PC Kingston, Pennsylvania  18704
Hematology Oncology Associates of the Treasure Coast Port St. Lucie, Florida  34952
The West Clinic Memphis, Tennessee  38120
The Cancer Institute of New Jersey New Brunswick, New Jersey  08901
Northwest Georgia Oncology Centers, P.C. Marietta, Georgia  30060
University of Miami School of Medicine Miami, Florida  33136
University of Southern California Los Angeles, California  90033
University of Cincinnati Cincinnati, Ohio  45267-0502
Missouri Baptist Medical Center Saint Louis, Missouri  63131
Cornell University New York, New York  10021
Kansas City Cancer Center Kansas City, Kansas  66112
Oncology Specialists Park Ridge, Illinois  60068
Maryland Oncology Hematology, P.A. Columbia, Maryland  21044
Sarah Cannon Research Institute Nashville, Tennessee  37203
Desert Hematology Oncology Medical Group Rancho Mirage, California  92270
Cancer Care Centers of South Texas San Antonio, Texas  78229
Yakima Valley Memorial Hospital/North Star Lodge Yakima, Washington  98902
Texas Oncology-Austin Midtown Austin, Texas  78705
Northeast Georgia Cancer Care Athens, Georgia  30607
Advanced Medical Specialties Miami, Florida  33176
Northwest Cancer Specialists, P.C. Portland, Oregon  97227
Washington University in St. Louis St. Louis, Missouri  63110
Carolinas Hematology Oncology Associates Charlotte, North Carolina  28203
Florida Cancer Research Institute Davie, Florida  
Louisville Oncology Clinical Research Program Louisville, Kentucky  40202
Central Georgia Cancer Care Macon, Georgia  31201
Peachtree Hematology Oncology Consultants Atlanta, Georgia  30309
Sarah Cannon Research Institute (SCRI) Nashville, Tennessee  37203
Signal Point Clinical Research Center Middletown, Ohio  45042
UNM Cancer Center Albuquerque, New Mexico  87106
Texas Oncology-Tyler Tyler, Texas  75702
Frontier Cancer Center and Blood Institute Billings, Montana  59102
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Arizona Oncology Associates, PC - NAHOA Sedona, Arizona  86336
Texas Oncology-Dallas Presbyterian Hospital Dallas, Texas  75231
Texas Oncology-Memorial City Houston, Texas  77024
Texas Oncology-Mesquite Mesquite, Texas  75150
Texas Oncology-Midland Allison Cancer Center Midland, Texas  79701
Texas Oncology-Baylor Charles A. Sammons Cancer Center Dallas, Texas  75246
Texas Oncology-Beaumont, Mamie McFaddin Ward Cancer Center Beaumont, Texas  77702
PMK Medical Group, Inc., dba Ventura County Hematology Oncology Specialists Oxnard, California  93030
Cancer Team Bellin Health Green Bay, Wisconsin  54313
Texas Oncology-Medical City Dallas Dallas, Texas  75230-2510
Texas Oncology - Sherman Sherman, Texas  75090-0504
Texas Oncology-Lewisville Lewisville, Texas  ??75067
Providence Health System - Southern California d/b/a Roy and Patricia Disney Family Cancer Center Burbank, California  91505
Illinois Cancer Care, P.C. Peoria, Illinois  61547
Hall-Perrine Cancer Center, 3rd Floor Cedar Rapids, Iowa  52403
Sciode Medical Associates, PLLC, d.b.a. Eastchester Center for Cancer Care Bronx, New York  10469
DUMC, Duke South Durham, North Carolina  27710
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Texas Oncology-Bedford Bedford, Texas  76022
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Texas Oncology-Fort Worth Fort Worth, Texas  76104
Texas Oncology, P.A. - Plano Plano, Texas  92270
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Medstar Washington DC, District of Columbia  20010
Summit Cancer Care, P.C. Savannah, Georgia  31405
The University of Chicago Medicine Chicago, Illinois  60637
IU Health Simon Cancer Center Indianapolis, Indiana  46202
Monte fiore Bronx, New York  10461
Comprehensive Breast Cancer Columbus, Ohio  43212
Sanford Research/USD Sioux Falls, South Dakota  57104