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 disease has progressed on or after prior endocrine therapy. Patients must undergo molecular pre-screening prior to entry.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
97
Active Dovitinib (in tablet form) taken orally at a dose of 500 mg (i.e., 5 x 100mg tablets) on a 5 days on/2 days off dosing schedule
Fulvestrant (in solution) injected intramuscularly at a dose of 500 mg once on Week 1 Day 1, Week 3 Day 1 and Week 5 Day 1 and subsequently once every 4 weeks on Day 1 of the week.
Dovitinib Placebo (in tablet form) taken orally at a dose of 500 mg (i.e., 5 x 100mg tablets) on a 5 days on/2 days off dosing schedule
Progression Free Survival (PFS) Based on Local Investigator Assessment
PFS was defined as the time from the date of randomization to the date of the first radiologically documented disease progression or death due to any cause and was assessed based on RECIST v1.1. Responses include: Complete Response: Disappearance of all non-nodal target lesions; Partial Response: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters; Progressive Disease: At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline; Stable Disease: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD; Unknown (UNK) Progression has not been documented and one or more target lesions have not been assessed or have been assessed using a different method than baseline.
Time frame: Every 8 weeks assessed up to 34 months
Overall Response Rate (ORR)
ORR was defined as the percentage of patients with a best overall response of Complete Response (CR) or Partial Response (PR) as per RECIST v1.1. Responses include: Complete Response: Disappearance of all non-nodal target lesions; Partial Response: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters; Progressive Disease: At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline; Stable Disease: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD; Unknown (UNK) Progression has not been documented and one or more target lesions have not been assessed or have been assessed using a different method than baseline.
Time frame: Every 8 weeks assessed up to 34 months
Duration of Response (DOR)
DOR was defined as time from the date of the first documented response (CR or PR) to the date of the first documented or death due to disease. If a patient does not have a progression event, DOR will be censored on the date of the last adequate tumor assessment.
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Ironwood Cancer and Research Centers SC
Chandler, Arizona, United States
Highlands Oncology Group Dept of Highlands Oncology Grp
Fayetteville, Arkansas, United States
City of Hope National Medical Center COH 3
Duarte, California, United States
University of California San Diego - Moores Cancer Center Moores UCSD Cancer Ctr. SC-1
La Jolla, California, United States
Cedars Sinai Medical Center Samuel Oschin Cancer Center
Los Angeles, California, United States
H. Lee Moffitt Cancer Center & Research Institute H. Lee Moffitt SC
Tampa, Florida, United States
Oncology Specialists, SC Lutheran General Advanced Care
Park Ridge, Illinois, United States
Indiana University Health Goshen Center for Cancer SC
Goshen, Indiana, United States
Nebraska Methodist Hospital Estabrook Cancer Center
Omaha, Nebraska, United States
Saint Barnabas Medical Center CancerCenter of Saint Barnabas
Livingston, New Jersey, United States
...and 57 more locations
Time frame: From date of first documented efficacy response (CR or PR) to time of documented progression (PD) whichever comes first, assessed up to 24 months
Overall Survival (OS) Using Kaplan- Meier Method
OS was defined as the time from the date of randomization to the date of death from any cause. If a patient is not known to have died at the date of analysis cut-off, the OS will be censored at the last date of contact.
Time frame: From date of randomization to date of death from any cause whichever comes first, assessed up to 34 months
Number of Participants With Adverse Events as a Measure of Safety
The type, frequency and severity of adverse events, laboratory values, and Electrocardiograms (ECGs) experienced by patients will be assessed according to Common Terminology Criteria for Adverse Events. The study enrollment was terminated early due to challenges in enrolling patients with FGF amplified status. See safety section for safety details.
Time frame: Screening, Week 2, Week 4 and approximately every 4 weeks during treatment period (approximately 34 months)
Time to Worsening of ECOG Performance Status
Eastern Cooperative Oncology Group (ECOG) Performance Status (scales and criteria used by doctors and researchers to assess how a patient's disease is progressing and assess how the disease affects the daily living abilities of the patient.)
Time frame: Screening, Every 4 weeks during treatment period, and every 8 weeks during follow-up (approximately 9-12 months)