Status:

TERMINATED

Trial Evaluating Dovitinib Combined With Fulvestrant, in Postmenopausal Patients With HER2- and HR+ Breast Cancer

Lead Sponsor:

Novartis Pharmaceuticals

Conditions:

Metastatic Breast Cancer

Eligibility:

FEMALE

18+ years

Phase:

PHASE2

Brief Summary

This trial is designed to enroll postmenopausal patients with locally advanced or metastatic, HER2- and HR+ breast cancer not amenable to curative treatment by surgery or radiotherapy, and whose disea...

Eligibility Criteria

Inclusion

  • Postmenopausal women with HER2-, HR+ locally advanced or metastatic breast cancer
  • Progression on or after endocrine treatment
  • Measureable disease as per RECIST
  • ECOG 0, 1 or 2

Exclusion

  • Evidence of CNS or leptomeningeal metastases
  • Previous treatment with fulvestrant
  • Previous chemotherapy for locally advanced or metastatic breast cancer
  • Cirrhosis or chronic active/persistent hepatitis
  • Other protocol-defined inclusion/exclusion criteria may apply

Key Trial Info

Start Date :

April 1 2012

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 1 2015

Estimated Enrollment :

97 Patients enrolled

Trial Details

Trial ID

NCT01528345

Start Date

April 1 2012

End Date

April 1 2015

Last Update

July 11 2016

Active Locations (67)

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Page 1 of 17 (67 locations)

1

Ironwood Cancer and Research Centers SC

Chandler, Arizona, United States, 85224

2

Highlands Oncology Group Dept of Highlands Oncology Grp

Fayetteville, Arkansas, United States, 72703

3

City of Hope National Medical Center COH 3

Duarte, California, United States, 91010-3000

4

University of California San Diego - Moores Cancer Center Moores UCSD Cancer Ctr. SC-1

La Jolla, California, United States, 92093-0658