Trial Outcomes & Findings for Sorafenib and Fulvestrant in Treating Patients With Locally Advanced or Metastatic Breast Cancer That Did Not Respond to Aromatase Inhibitor Therapy (NCT NCT00722072)

Results Overview

Progression-free survival rate is defined as the proportion of subjects who are progression free (CR, PR and SD) at 4 months after initiating treatment with sorafenib plus fulvestrant. Complete Response (CR):Disappearance of all target (both measurable and evaluable)lesions. Partial Response (PR):At least a 30% decrease in the sum of the longest diameter (LD) of both measurable and evaluable target lesions. Stable Disease (SD):Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease(PD).

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

12 participants

Primary outcome timeframe

4 months after initiating treatment with sorafenib plus fulvestrant.

Results posted on

2018-02-26

Participant Flow

Participant milestones

Participant milestones
Measure	Sorafenib and Fulvestrant Fulvestrant:Will be administered to the subject intramuscularly. Administered to all subjects during cycle 1 of treatment as follows: * 500 mg IM on Day 1 * 250 mg IM on Day 15 Sorafenib: 800 mg/day administered as 400 mg bid (twice daily) each morning and evening approximately 12 hours apart. Treatment will begin on Day 1 of the study and continue daily until tumor progression or until an unacceptable toxicity occurs which would require delay, modification or discontinuation of study therapy.
Overall Study STARTED	12
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sorafenib and Fulvestrant in Treating Patients With Locally Advanced or Metastatic Breast Cancer That Did Not Respond to Aromatase Inhibitor Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sorafenib and Fulvestrant n=12 Participants Fulvestrant:Will be administered to the subject intramuscularly. Administered to all subjects during cycle 1 of treatment as follows: * 500 mg IM on Day 1 * 250 mg IM on Day 15 Sorafenib: 800 mg/day administered as 400 mg bid (twice daily) each morning and evening approximately 12 hours apart. Treatment will begin on Day 1 of the study and continue daily until tumor progression or until an unacceptable toxicity occurs which would require delay, modification or discontinuation of study therapy.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Age, Continuous	57.166 years STANDARD_DEVIATION 9.0235 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 months after initiating treatment with sorafenib plus fulvestrant.

Progression-free survival rate is defined as the proportion of subjects who are progression free (CR, PR and SD) at 4 months after initiating treatment with sorafenib plus fulvestrant. Complete Response (CR):Disappearance of all target (both measurable and evaluable)lesions. Partial Response (PR):At least a 30% decrease in the sum of the longest diameter (LD) of both measurable and evaluable target lesions. Stable Disease (SD):Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease(PD).

Outcome measures

Outcome measures
Measure	Sorafenib and Fulvestrant n=12 Participants Fulvestrant:Will be administered to the subject intramuscularly. Administered to all subjects during cycle 1 of treatment as follows: * 500 mg IM on Day 1 * 250 mg IM on Day 15 Sorafenib: 800 mg/day administered as 400 mg bid (twice daily) each morning and evening approximately 12 hours apart. Treatment will begin on Day 1 of the study and continue daily until tumor progression or until an unacceptable toxicity occurs which would require delay, modification or discontinuation of study therapy.
Number of Participants With Progression-free Survival at 4 Months	6 Participants

SECONDARY outcome

Timeframe: Every 8 weeks (two cycles) while receiving study therapy.

Population: Response assessment data was not collected past 4 months due to early study termination.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Start of treatment to time of progression.

Population: Progression data was not collected due to early study termination.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Start of treatment to time of progression or death, whichever comes first.

Population: Long term survival data was not collected due to early study termination

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 28 to 56 days after discontinuation of study therapy

Population: Long term survival data was not collected due to early study termination

Outcome measures

Outcome data not reported

Adverse Events

Sorafenib and Fulvestrant

Serious events: 3 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Sorafenib and Fulvestrant n=9 participants at risk Fulvestrant:Will be administered to the subject intramuscularly. Administered to all subjects during cycle 1 of treatment as follows: * 500 mg IM on Day 1 * 250 mg IM on Day 15 Sorafenib: 800 mg/day administered as 400 mg bid (twice daily) each morning and evening approximately 12 hours apart. Treatment will begin on Day 1 of the study and continue daily until tumor progression or until an unacceptable toxicity occurs which would require delay, modification or discontinuation of study therapy.
General disorders Hand-foot syndrome (HFS)	33.3% 3/9
Skin and subcutaneous tissue disorders Rash	33.3% 3/9
Skin and subcutaneous tissue disorders Desquamation	33.3% 3/9

Other adverse events

Other adverse events
Measure	Sorafenib and Fulvestrant n=9 participants at risk Fulvestrant:Will be administered to the subject intramuscularly. Administered to all subjects during cycle 1 of treatment as follows: * 500 mg IM on Day 1 * 250 mg IM on Day 15 Sorafenib: 800 mg/day administered as 400 mg bid (twice daily) each morning and evening approximately 12 hours apart. Treatment will begin on Day 1 of the study and continue daily until tumor progression or until an unacceptable toxicity occurs which would require delay, modification or discontinuation of study therapy.
Blood and lymphatic system disorders Neutropenia	100.0% 9/9
Musculoskeletal and connective tissue disorders Myalgias	100.0% 9/9
Infections and infestations Arthralgias	100.0% 9/9
General disorders Fatigue	100.0% 9/9
Skin and subcutaneous tissue disorders Pruritis	100.0% 9/9

Additional Information

Dr. Stephen Chui

OHSU Knight Cancer Institute

Phone: 503-494-8534

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place