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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Nektar Therapeutics
ClinicalTrials.gov Identifier:
NCT01492101
First received: December 12, 2011
Last updated: August 2, 2013
Last verified: August 2013
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Nektar Therapeutics:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: 36 Months ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 840
Study Start Date: December 2011
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01492101

  Show 153 Study Locations
Sponsors and Collaborators
Nektar Therapeutics
Investigators
Study Director: Robert Medve, MD Nektar Therapeutics
  More Information

No publications provided

Responsible Party: Nektar Therapeutics
ClinicalTrials.gov Identifier: NCT01492101     History of Changes
Other Study ID Numbers: 11-PIR-11
Study First Received: December 12, 2011
Last Updated: August 2, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 23, 2014