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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01492101
Recruitment Status : Completed
First Posted : December 14, 2011
Last Update Posted : August 4, 2016
Information provided by (Responsible Party):
Nektar Therapeutics

Brief 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.

Condition or disease Intervention/treatment Phase
Locally Recurrent Breast Cancer Metastatic Breast Cancer Drug: NKTR-102 Drug: Treatment of Physician's Choice (TPC) Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 852 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : December 2011
Actual Primary Completion Date : April 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: NKTR-102 Drug: NKTR-102
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: Physician's Treatment of Choice Drug: 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 Outcome Measures :
  1. Overall Survival [ Time Frame: 36 Months ]
    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, gemcitabine, paclitaxel, docetaxel or nab-paclitaxel

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01492101

  Show 153 Study Locations
Sponsors and Collaborators
Nektar Therapeutics
Study Director: Ivan Gergel, MD Nektar Therapeutics

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Nektar Therapeutics Identifier: NCT01492101     History of Changes
Other Study ID Numbers: 11-PIR-11
First Posted: December 14, 2011    Key Record Dates
Last Update Posted: August 4, 2016
Last Verified: August 2016

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases