Trial Outcomes & Findings for Sorafenib and Letrozole, Anastrozole, or Exemestane in Treating Postmenopausal Women With Estrogen Receptor-Positive and/or Progesterone Receptor-Positive Metastatic Breast Cancer (NCT NCT00573755)
NCT ID: NCT00573755
Last Updated: 2016-02-05
Results Overview
Progression-free survival was defined as the time from randomization to the earliest date of documentation of disease progression or death due to any cause. In the case of a participant started treatment and then never return for any evaluations, the participant was censored for progression 1 day post-randomization.
TERMINATED
PHASE2
4 participants
Time from randomization to disease progression or death (up to 5 years)
2016-02-05
Participant Flow
Four (4) participants were recruited at Mayo Clinic between January 2008 and August 2008. This trial was terminated early due to lack of participant accrual.
Participant milestones
| Measure |
Sorafenib Plus Aromatase Inhibitor
Patients receive oral sorafenib tosylate twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
|
Placebo Plus Aromatase Inhibitor
Patients receive oral placebo twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
|
Overall Study
COMPLETED
|
1
|
2
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Sorafenib Plus Aromatase Inhibitor
Patients receive oral sorafenib tosylate twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
|
Placebo Plus Aromatase Inhibitor
Patients receive oral placebo twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
Still receiving treatment
|
1
|
0
|
Baseline Characteristics
Sorafenib and Letrozole, Anastrozole, or Exemestane in Treating Postmenopausal Women With Estrogen Receptor-Positive and/or Progesterone Receptor-Positive Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Sorafenib Plus Aromatase Inhibitor
n=2 Participants
Patients receive oral sorafenib tosylate twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
|
Placebo Plus Aromatase Inhibitor
n=2 Participants
Patients receive oral placebo twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.0 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
54.5 years
STANDARD_DEVIATION 4.9 • n=7 Participants
|
61.3 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Time from randomization to disease progression or death (up to 5 years)Population: All participants who have met the eligibility criteria, signed a consent form and were randomized to one of the two treatment groups were evaluable for the primary endpoint.
Progression-free survival was defined as the time from randomization to the earliest date of documentation of disease progression or death due to any cause. In the case of a participant started treatment and then never return for any evaluations, the participant was censored for progression 1 day post-randomization.
Outcome measures
| Measure |
Sorafenib Plus Aromatase Inhibitor
n=2 Participants
Patients receive oral sorafenib tosylate twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
|
Placebo Plus Aromatase Inhibitor
n=2 Participants
Patients receive oral placebo twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Progression-free Survival
|
NA months
There is not enough events reported to compute median and 95% Confidence Interval (CI).
|
NA months
One participant had a progression at 12.5 months. There is not enough events reported to compute median and 95% CI.
|
SECONDARY outcome
Timeframe: Time from randomization to death (up to 5 years)Population: The number of patients enrolled in the study does not allow for meaningful analysis for this outcome. All patients were alive at the time of their last treatment follow up.
Survival time was defined as the time from randomization to death due to any cause.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Time from randomization to treatment failure (up to 5 years)Population: The number of patients enrolled in the study does not allow for meaningful analysis for this outcome.
Time to treatment failure was defined as the time from the date of the randomization to the date at which the patient was removed from treatment due to progression, adverse events, or refusal.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: The number of patients enrolled in the study does not allow for meaningful analysis for this outcome.
A confirm response was defined as either a complete response (CR) or partial response (PR) noted as the objective status on 2 consecutive evaluation at least 4 weeks apart. The confirmed response rate was estimated within each treatment group by the number of confirmed responses divided by the total number of participants randomized.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: The number of patients enrolled in the study does not allow for meaningful analysis for this outcome.
Duration of response was defined for all patients who have achieved a confirmed response as the date at which the patient's earliest best objective status was first noted to be either a CR or PR to the earliest date progression was documented.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Time from randomization to end of treatmentNumber of participants that experienced adverse events (grade 3 and above) as measured by NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Adverse events were assessed every week during first 6 weeks of therapy, every 4 weeks on months 1 to 6, every 12 weeks on months 7 and beyond and at the end of treatment.
Outcome measures
| Measure |
Sorafenib Plus Aromatase Inhibitor
n=2 Participants
Patients receive oral sorafenib tosylate twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
|
Placebo Plus Aromatase Inhibitor
n=2 Participants
Patients receive oral placebo twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Adverse Event
Fatigue
|
1 participants
|
0 participants
|
|
Adverse Event
Hemoglobin decreased
|
1 participants
|
0 participants
|
|
Adverse Event
Mucositis oral
|
1 participants
|
0 participants
|
|
Adverse Event
Muscle weakness
|
1 participants
|
0 participants
|
|
Adverse Event
Platelet count decreased
|
1 participants
|
0 participants
|
|
Adverse Event
Serum potassium increased
|
1 participants
|
0 participants
|
|
Adverse Event
Thrombotic microangiopathy
|
1 participants
|
0 participants
|
|
Adverse Event
Serum sodium decreased
|
1 participants
|
0 participants
|
|
Adverse Event
Mucositis oral (clin exam)
|
1 participants
|
0 participants
|
Adverse Events
Sorafenib Plus Aromatase Inhibitor
Placebo Plus Aromatase Inhibitor
Serious adverse events
| Measure |
Sorafenib Plus Aromatase Inhibitor
n=2 participants at risk
Patients receive oral sorafenib tosylate twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
|
Placebo Plus Aromatase Inhibitor
n=2 participants at risk
Patients receive oral placebo twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
50.0%
1/2 • Number of events 1
|
0.00%
0/2
|
|
Blood and lymphatic system disorders
Thrombotic microangiopathy
|
50.0%
1/2 • Number of events 1
|
0.00%
0/2
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
50.0%
1/2 • Number of events 1
|
0.00%
0/2
|
|
Gastrointestinal disorders
Mucositis oral
|
50.0%
1/2 • Number of events 1
|
0.00%
0/2
|
|
General disorders
Fatigue
|
50.0%
1/2 • Number of events 1
|
0.00%
0/2
|
|
Investigations
Platelet count decreased
|
50.0%
1/2 • Number of events 1
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
50.0%
1/2 • Number of events 1
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
50.0%
1/2 • Number of events 1
|
0.00%
0/2
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
50.0%
1/2 • Number of events 1
|
0.00%
0/2
|
Other adverse events
| Measure |
Sorafenib Plus Aromatase Inhibitor
n=2 participants at risk
Patients receive oral sorafenib tosylate twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
|
Placebo Plus Aromatase Inhibitor
n=2 participants at risk
Patients receive oral placebo twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
50.0%
1/2 • Number of events 1
|
50.0%
1/2 • Number of events 6
|
|
Endocrine disorders
Hypothyroidism
|
50.0%
1/2 • Number of events 2
|
0.00%
0/2
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
1/2 • Number of events 4
|
0.00%
0/2
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
50.0%
1/2 • Number of events 1
|
0.00%
0/2
|
|
General disorders
Edema limbs
|
50.0%
1/2 • Number of events 2
|
0.00%
0/2
|
|
General disorders
Fatigue
|
100.0%
2/2 • Number of events 17
|
50.0%
1/2 • Number of events 2
|
|
Investigations
Platelet count decreased
|
50.0%
1/2 • Number of events 1
|
50.0%
1/2 • Number of events 1
|
|
Investigations
Weight loss
|
50.0%
1/2 • Number of events 1
|
50.0%
1/2 • Number of events 1
|
|
Renal and urinary disorders
Protein urine positive
|
50.0%
1/2 • Number of events 1
|
0.00%
0/2
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
50.0%
1/2 • Number of events 21
|
0.00%
0/2
|
|
Skin and subcutaneous tissue disorders
Hand-and-foot syndrome
|
50.0%
1/2 • Number of events 4
|
0.00%
0/2
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
50.0%
1/2 • Number of events 1
|
0.00%
0/2
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
50.0%
1/2 • Number of events 2
|
50.0%
1/2 • Number of events 2
|
|
Vascular disorders
Hypertension
|
50.0%
1/2 • Number of events 10
|
0.00%
0/2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place