Clinical trial NCT00615524: Phase II Study Evaluating Exemestane Alone Or In Combination With Pazopanib In Postmenopausal Women With Hormone Receptor Positive Breast Cancer
Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Study to Compare the Efficacy and Tolerability of Pazopanib Administered in Combination With Exemestane Versus Exemestane Plus Placebo in Postmenopausal Subjects With Advanced or Metastatic Hormone Receptor Positive Breast Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Hormone-receptor Positive Breast Cancer
Keywords: Breast cancer
Advanced
Metastatic
Pazopanib
GW786034
Exemestane
Efficacy
Tolerability
Health-Related Quality of Life
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-02-14
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is being conducted to compare the efficacy and safety of exemestane alone or in combination with pazopanib in postmenopausal women who have hormone receptor positive breast cancer and have failed therapy with tamoxifen, anastrazole or letrozole.


Eligibility criteria: Inclusion Criteria:

* Subjects must have measurable disease OR must be evaluable for disease progression
* Age \>/= 18 years.
* Postmenopausal women
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.
* Histologically or cytologically confirmed ER and/or PgR positive carcinoma of the breast with unresectable, locally advanced and/or metastatic disease
* Subjects must have received prior hormonal therapy for the treatment of breast cancer (anastrozole, letrozole, or tamoxifen)
* Adequate hematologic, hepatic, and renal function

Exclusion Criteria:

* Prior use of exemestane or pazopanib
* Premenopausal women
* Any ongoing toxicity from prior anti-cancer therapy that is \>Grade 1 and/or that is progressing in severity.
* Prior therapy with a VEGF inhibitor.
* Use of an investigational agent, including an investigational anti-cancer agent, within 28 days or 5 half-lives, whichever is longer, prior to the first dose of investigational product.
* Evidence of recurrence or active disease from prior malignancy.
* Clinically significant gastrointestinal abnormalities that may increase the risk for GI bleeding or affect the absorption of the investigational product(s).
* Presence of uncontrolled infection.
* History of any major cardiovascular conditions within the past 6 months:
* Poorly controlled hypertension
* History of cerebrovascular accident, pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months.
* Prior major surgery or trauma within 28 days prior to first dose of investigational product and/or presence of any non-healing wound, fracture, or ulcer
* Evidence of active bleeding or bleeding tendency.

Primary outcomes:
measure: Progression free survival
Secondary outcomes:
measure: Safety and tolerability Overall response rate (complete and partial responses) in subjects with measurable disease Overall survival Change in health-related quality of life (HRQL) relative to baseline Biomarkers
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: GSK Clinical Trials Call Center
state: California
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials, MD
role: STUDY_DIRECTOR
References: