A Clinical Trial Assessing Efficacy and Safety of Sunitinib and Exemestane in Patients With ER [Estrogen Receptor] + and/or PgR [Progesterone Receptor] + Breast Cancer
- Registration Number
- NCT00417885
- Lead Sponsor
- Pfizer
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 6
- 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)]
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description A exemestane sunitinib + exemestane A sunitinib malate sunitinib + exemestane
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇨🇦Montreal, Quebec, Canada