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The BEACON Study (Breast Cancer Outcomes With NKTR-102) | Clinical Trials | Clareo Health

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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

NCT01492101•Nektar Therapeutics

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

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 (153)

Arizona Oncology Associates, PC - NAHOA

Flagstaff, Arizona, United States

Providence Health System - Southern California d/b/a Roy and Patricia Disney Family Cancer Center

Burbank, California, United States

University of Southern California

Los Angeles, California, United States

PMK Medical Group, Inc., DBA Ventura County Hematology Oncology Specialists

Oxnard, California, United States

Wilshire Oncology Medical Group, Inc.

Pasadena, California, United States

Desert Hematology Oncology Medical Group

Rancho Mirage, California, United States

University of California San Francisco

San Francisco, California, United States

Stanford University School of Medicine

Stanford, California, United States

Kaiser Permanente

Vallejo, California, United States

Rocky Mountain Cancer Centers

Denver, Colorado, United States

Key Dates

Start Date

December 1, 2011

Primary Completion Date

April 1, 2016

Completion Date

June 1, 2016

Last Updated

June 1, 2021

Enrollment

852

ACTUAL participants

Conditions

Locally Recurrent Breast CancerMetastatic Breast Cancer

Interventions

NKTR-102

DRUG

Treatment of Physician's Choice (TPC)

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 1, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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