Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

All Drugs and Chemicals

Antineoplastic Agents

Hormones

Exemestane

Estrogens

Sunitinib

Progesterone

Angiogenesis Inhibitors

Growth Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Aromatase Inhibitors

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormone Antagonists

exemestane

sunitinib malate

Pfizer CT.gov Call Center

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.

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.

A Clinical Trial Assessing Efficacy and Safety of Sunitinib and Exemestane in Patients With ER [Estrogen Receptor] + and/or PgR [Progesterone Receptor] + Breast Cancer

Phase 1/2 Open-Label Trial Of Sutent (Sunitinib Malate) And Aromasin(Exemestane) In The First-Line Treatment Of Hormone Receptor-Positive Metastatic Breast Cancer

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.

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.

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.

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.

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.

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.

Pfizer

Director, Clinical Trial Disclosure Group

Sunitinib administered orally, in a continuous regimen, dose of 37.5 mg daily. Exemestane coadministered orally at a dose of 25 mg daily.

Sunitinib + Exemestane

< 18 years

18 to 44 years

45 to 64 years

> = 65 years

Age, Customized

Sex: Female, Male

Pfizer ClinicalTrials.gov Call Center

Intent-To-Treat (ITT) = all subjects who were enrolled in the trial. Data were not analyzed due to early termination.

Progression Free Survival (PFS)

Analyses on OR were performed for subjects who received at least 1 dose of study medication.

Overall Response (OR) According to the Response Evaluation Criteria in Solid Tumors (RECIST)

Analyses on DR were to be performed for overall responders only. Data were not analyzed due to early termination.

Spots Global Cancer Trial Database 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

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