Breast Neoplasms
Conditions
Brief summary
To assess progression-free survival at the combination dose determined in the Phase 1 portion of the study, and safety of sunitinib combined with exemestane in patients with metastatic or locally-recurrent, unresectable breast cancer.
Detailed description
The trial was terminated prematurely on August 28, 2008 due to the inability to recruit the planned number of subjects in order to provide meaningful efficacy data. There were no safety concerns regarding the study in the decision to terminate the trial.
Interventions
DRUGexemestane
25 mg, oral, daily dosing
DRUGsunitinib malate
37.5 mg, oral, continuous dosing, daily
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least 18 years of age * Estrogen and/or progesterone receptor positive adenocarcinoma of the breast with evidence of 1) unresectable 2)locally recurrent, or 3) metastatic disease * Postmenopausal * ECOG \[Eastern Cooperative Oncology Group\] \</=1 * Evaluable(e.g bone only disease allowed) and Measurable disease \[RECIST (Response Evaluation Criterion in Solid Tumors)\]
Exclusion criteria
* HER2 \[Human Epidermal Growth factor Receptor 2\] positive disease not previously treated with herceptin * Any prior anti-angiogenic therapy, endocrine or cytotoxic anti-cancer therapy in the metastatic disease setting * Radiation therapy within 2 weeks of first study treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS) | From start of treatment until Day 1 of every other cycle (8 weeks) or death | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response (OR) According to the Response Evaluation Criteria in Solid Tumors (RECIST) | From start of treatment until Day 1 of every other cycle (8 weeks) | 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. |
| Duration of Response (DR) | From start of treatment until Day 1 of every other cycle (8 weeks) or death due to cancer | 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. |
| Overall Survival (OS) | From start of study treatment until death | 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. |
| Time to Tumor Progression (TTP) | From start of treatment until Day 1 of every other cycle (8 weeks) | 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. |
| Clinical Benefit Rate (CBR) | From start of treatment until Day 1 of every other cycle (8 weeks) | 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. |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 6 |
| Total | 6 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Objective Progression or Relapse | 3 |
| Overall Study | Transferred to Another Sunitinib Study | 2 |
Baseline characteristics
| Characteristic | Sunitinib + Exemestane |
|---|---|
| Age, Customized 18 to 44 years | 0 participants |
| Age, Customized < 18 years | 0 participants |
| Age, Customized 45 to 64 years | 4 participants |
| Age, Customized > = 65 years | 2 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 6 / 6 |
| serious Total, serious adverse events | 3 / 6 |
Outcome results
Primary
Progression Free Survival (PFS)
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.
Time frame: From start of treatment until Day 1 of every other cycle (8 weeks) or death
Population: Intent-To-Treat (ITT) = all subjects who were enrolled in the trial. Data were not analyzed due to early termination.
Secondary
Clinical Benefit Rate (CBR)
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.
Time frame: From start of treatment until Day 1 of every other cycle (8 weeks)
Population: ITT. Data were not analyzed due to early termination.
Secondary
Duration of Response (DR)
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.
Time frame: From start of treatment until Day 1 of every other cycle (8 weeks) or death due to cancer
Population: Analyses on DR were to be performed for overall responders only. Data were not analyzed due to early termination.
Secondary
Overall Response (OR) According to the Response Evaluation Criteria in Solid Tumors (RECIST)
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sunitinib + Exemestane | Overall Response (OR) According to the Response Evaluation Criteria in Solid Tumors (RECIST) | CR | 1 participants |
| Sunitinib + Exemestane | Overall Response (OR) According to the Response Evaluation Criteria in Solid Tumors (RECIST) | PR | 1 participants |
| Sunitinib + Exemestane | Overall Response (OR) According to the Response Evaluation Criteria in Solid Tumors (RECIST) | PD | 1 participants |
| Sunitinib + Exemestane | Overall Response (OR) According to the Response Evaluation Criteria in Solid Tumors (RECIST) | SD | 3 participants |
Secondary
Overall Survival (OS)
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.
Time frame: From start of study treatment until death
Population: ITT. Data were not analyzed due to early termination.
Secondary
Time to Tumor Progression (TTP)
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.
Time frame: From start of treatment until Day 1 of every other cycle (8 weeks)
Population: ITT. Data were not analyzed due to early termination.