Trial Outcomes & Findings for A Clinical Trial Assessing Efficacy and Safety of Sunitinib and Exemestane in Patients With ER [Estrogen Receptor] + and/or PgR [Progesterone Receptor] + Breast Cancer (NCT NCT00417885)
NCT ID: NCT00417885
Last Updated: 2010-09-21
Results Overview
PFS was defined as the time from enrollment to first documentation of objective tumor progression or to death on study due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. PFS was to be calculated as (first event date - the date of enrollment +1)/7.
TERMINATED
PHASE1/PHASE2
6 participants
From start of treatment until Day 1 of every other cycle (8 weeks) or death
2010-09-21
Participant Flow
Participant milestones
| Measure |
Sunitinib + Exemestane
Sunitinib administered orally, in a continuous regimen, dose of 37.5 mg daily. Exemestane coadministered orally at a dose of 25 mg daily.
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Sunitinib + Exemestane
Sunitinib administered orally, in a continuous regimen, dose of 37.5 mg daily. Exemestane coadministered orally at a dose of 25 mg daily.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Objective Progression or Relapse
|
3
|
|
Overall Study
Transferred to Another Sunitinib Study
|
2
|
Baseline Characteristics
A Clinical Trial Assessing Efficacy and Safety of Sunitinib and Exemestane in Patients With ER [Estrogen Receptor] + and/or PgR [Progesterone Receptor] + Breast Cancer
Baseline characteristics by cohort
| Measure |
Sunitinib + Exemestane
n=6 Participants
Sunitinib administered orally, in a continuous regimen, dose of 37.5 mg daily. Exemestane coadministered orally at a dose of 25 mg daily.
|
|---|---|
|
Age, Customized
< 18 years
|
0 participants
n=5 Participants
|
|
Age, Customized
18 to 44 years
|
0 participants
n=5 Participants
|
|
Age, Customized
45 to 64 years
|
4 participants
n=5 Participants
|
|
Age, Customized
> = 65 years
|
2 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From start of treatment until Day 1 of every other cycle (8 weeks) or deathPopulation: Intent-To-Treat (ITT) = all subjects who were enrolled in the trial. Data were not analyzed due to early termination.
PFS was defined as the time from enrollment to first documentation of objective tumor progression or to death on study due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. PFS was to be calculated as (first event date - the date of enrollment +1)/7.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From start of treatment until Day 1 of every other cycle (8 weeks)Population: Analyses on OR were performed for subjects who received at least 1 dose of study medication.
OR=from start of treatment until disease progression/recurrence. Complete response (CR)=disappearance of all target lesions. Partial response (PR)= ? 30% decrease in sum of longest dimensions of lesions taking as reference baseline sum longest dimensions. Progressive disease (PD)= ? 20% increase in sum of longest dimensions of lesions taking as reference smallest sum of the longest dimensions since treatment started, or appearance of ? 1 new lesion. Stable disease (SD)=neither shrinkage for PR or increase for PD taking as reference smallest sum of longest dimensions since treatment start.
Outcome measures
| Measure |
Sunitinib + Exemestane
n=6 Participants
Sunitinib administered orally, in a continuous regimen, dose of 37.5 mg daily. Exemestane coadministered orally at a dose of 25 mg daily.
|
|---|---|
|
Overall Response (OR) According to the Response Evaluation Criteria in Solid Tumors (RECIST)
CR
|
1 participants
|
|
Overall Response (OR) According to the Response Evaluation Criteria in Solid Tumors (RECIST)
PR
|
1 participants
|
|
Overall Response (OR) According to the Response Evaluation Criteria in Solid Tumors (RECIST)
PD
|
1 participants
|
|
Overall Response (OR) According to the Response Evaluation Criteria in Solid Tumors (RECIST)
SD
|
3 participants
|
SECONDARY outcome
Timeframe: From start of treatment until Day 1 of every other cycle (8 weeks) or death due to cancerPopulation: Analyses on DR were to be performed for overall responders only. Data were not analyzed due to early termination.
DR was defined as the time from the first documentation of objective tumor response (CR or PR) to the first documentation of objective tumor progression or to death on study. If tumor progression data included more than 1 date, the first date was used. DR was to be calculated as (the end date for DR - first CR or PR that was subsequently confirmed +1)/7.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From start of study treatment until deathPopulation: ITT. Data were not analyzed due to early termination.
OS was defined as the time from date of enrollment to date of death due to any cause. OS was to be calculated as (the event date - the date of enrollment +1)/7.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From start of treatment until Day 1 of every other cycle (8 weeks)Population: ITT. Data were not analyzed due to early termination.
TTP was defined as the time from enrollment to first documentation of objective tumor progression. If tumor progression data included more than 1 date, the first date was used. TTP was to be calculated as (first event date - the date of enrollment +1)/7.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From start of treatment until Day 1 of every other cycle (8 weeks)Population: ITT. Data were not analyzed due to early termination.
The clinical benefit rate (CBR) was the measure for clinical benefit (CB) and was defined as the percent of subjects with confirmed CR or confirmed PR, or confirmed SD according to RECIST, relative to the total analysis population. CRs were those that persisted on repeat imaging study ?4 weeks after initial documentation of response.
Outcome measures
Outcome data not reported
Adverse Events
Sunitinib + Exemestane
Serious adverse events
| Measure |
Sunitinib + Exemestane
n=6 participants at risk
Sunitinib administered orally, in a continuous regimen, dose of 37.5 mg daily. Exemestane coadministered orally at a dose of 25 mg daily.
|
|---|---|
|
Gastrointestinal disorders
Pancreatitis acute
|
16.7%
1/6
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
16.7%
1/6
|
|
General disorders
General physical health deterioration
|
16.7%
1/6
|
|
Infections and infestations
Enterobacter sepsis
|
16.7%
1/6
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
16.7%
1/6
|
Other adverse events
| Measure |
Sunitinib + Exemestane
n=6 participants at risk
Sunitinib administered orally, in a continuous regimen, dose of 37.5 mg daily. Exemestane coadministered orally at a dose of 25 mg daily.
|
|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
16.7%
1/6
|
|
Cardiac disorders
Palpitations
|
16.7%
1/6
|
|
Endocrine disorders
Adrenal insufficiency
|
16.7%
1/6
|
|
Endocrine disorders
Diabetes insipidus
|
16.7%
1/6
|
|
Endocrine disorders
Hypothyroidism
|
50.0%
3/6
|
|
Eye disorders
Diplopia
|
16.7%
1/6
|
|
Eye disorders
Lacrimation increased
|
16.7%
1/6
|
|
Eye disorders
Myodesopsia
|
16.7%
1/6
|
|
Eye disorders
Vision blurred
|
16.7%
1/6
|
|
Eye disorders
Visual impairment
|
16.7%
1/6
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
2/6
|
|
Gastrointestinal disorders
Abdominal pain upper
|
16.7%
1/6
|
|
Gastrointestinal disorders
Constipation
|
50.0%
3/6
|
|
Gastrointestinal disorders
Diarrhoea
|
66.7%
4/6
|
|
Gastrointestinal disorders
Dry mouth
|
66.7%
4/6
|
|
Gastrointestinal disorders
Dyspepsia
|
16.7%
1/6
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
16.7%
1/6
|
|
Gastrointestinal disorders
Glossodynia
|
16.7%
1/6
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
16.7%
1/6
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6
|
|
Gastrointestinal disorders
Oesophagitis
|
16.7%
1/6
|
|
Gastrointestinal disorders
Oral pain
|
33.3%
2/6
|
|
Gastrointestinal disorders
Stomatitis
|
50.0%
3/6
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
3/6
|
|
General disorders
Chest pain
|
16.7%
1/6
|
|
General disorders
Fatigue
|
83.3%
5/6
|
|
General disorders
Fibrosis
|
16.7%
1/6
|
|
General disorders
Induration
|
16.7%
1/6
|
|
General disorders
Influenza like illness
|
16.7%
1/6
|
|
General disorders
Irritability
|
16.7%
1/6
|
|
General disorders
Mucosal inflammation
|
16.7%
1/6
|
|
General disorders
Oedema peripheral
|
16.7%
1/6
|
|
General disorders
Pyrexia
|
16.7%
1/6
|
|
Infections and infestations
Bronchitis
|
16.7%
1/6
|
|
Infections and infestations
Eye infection
|
16.7%
1/6
|
|
Infections and infestations
Lung infection
|
16.7%
1/6
|
|
Infections and infestations
Oral candidiasis
|
16.7%
1/6
|
|
Infections and infestations
Pneumonia
|
16.7%
1/6
|
|
Infections and infestations
Urinary tract infection
|
16.7%
1/6
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
2/6
|
|
Investigations
Aspartate aminotransferase increased
|
16.7%
1/6
|
|
Investigations
Blood bilirubin increased
|
16.7%
1/6
|
|
Investigations
Blood cholesterol increased
|
16.7%
1/6
|
|
Investigations
Blood creatinine increased
|
16.7%
1/6
|
|
Investigations
Blood potassium decreased
|
16.7%
1/6
|
|
Investigations
Cardiac murmur
|
16.7%
1/6
|
|
Investigations
Hepatic enzyme increased
|
16.7%
1/6
|
|
Investigations
Platelet count decreased
|
33.3%
2/6
|
|
Investigations
Weight decreased
|
50.0%
3/6
|
|
Metabolism and nutrition disorders
Anorexia
|
66.7%
4/6
|
|
Metabolism and nutrition disorders
Decreased appetite
|
16.7%
1/6
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
16.7%
1/6
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
50.0%
3/6
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
1/6
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
16.7%
1/6
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
16.7%
1/6
|
|
Nervous system disorders
Ageusia
|
16.7%
1/6
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6
|
|
Nervous system disorders
Dysgeusia
|
50.0%
3/6
|
|
Nervous system disorders
Headache
|
33.3%
2/6
|
|
Nervous system disorders
Hypoaesthesia
|
33.3%
2/6
|
|
Nervous system disorders
Lethargy
|
16.7%
1/6
|
|
Nervous system disorders
Migraine
|
16.7%
1/6
|
|
Nervous system disorders
Neuropathy peripheral
|
16.7%
1/6
|
|
Psychiatric disorders
Anxiety
|
16.7%
1/6
|
|
Psychiatric disorders
Confusional state
|
16.7%
1/6
|
|
Psychiatric disorders
Depression
|
33.3%
2/6
|
|
Psychiatric disorders
Insomnia
|
50.0%
3/6
|
|
Renal and urinary disorders
Micturition urgency
|
16.7%
1/6
|
|
Reproductive system and breast disorders
Breast pain
|
16.7%
1/6
|
|
Reproductive system and breast disorders
Uterine prolapse
|
16.7%
1/6
|
|
Reproductive system and breast disorders
Vaginal disorder
|
16.7%
1/6
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
16.7%
1/6
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
3/6
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
16.7%
1/6
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
16.7%
1/6
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
16.7%
1/6
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
16.7%
1/6
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
16.7%
1/6
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
16.7%
1/6
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
16.7%
1/6
|
|
Skin and subcutaneous tissue disorders
Acne
|
16.7%
1/6
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
16.7%
1/6
|
|
Skin and subcutaneous tissue disorders
Blister
|
16.7%
1/6
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
16.7%
1/6
|
|
Skin and subcutaneous tissue disorders
Hair colour changes
|
33.3%
2/6
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
16.7%
1/6
|
|
Skin and subcutaneous tissue disorders
Hypoaesthesia facial
|
16.7%
1/6
|
|
Skin and subcutaneous tissue disorders
Increased tendency to bruise
|
16.7%
1/6
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
16.7%
1/6
|
|
Skin and subcutaneous tissue disorders
Rash
|
33.3%
2/6
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
16.7%
1/6
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
16.7%
1/6
|
|
Skin and subcutaneous tissue disorders
Skin nodule
|
16.7%
1/6
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
16.7%
1/6
|
|
Skin and subcutaneous tissue disorders
Yellow skin
|
66.7%
4/6
|
|
Vascular disorders
Hypertension
|
50.0%
3/6
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER