Phase II Study Evaluating Exemestane Alone Or In Combination With Pazopanib In Postmenopausal Women With Hormone Receptor Positive Breast Cancer

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

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00615524

Enrollment

Registered

2008-02-14

Start date

2008-04-30

Completion date

2012-11-30

Last updated

2018-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hormone-receptor Positive Breast Cancer

Keywords

Breast cancer, Advanced, Metastatic, Pazopanib, GW786034, Exemestane, Efficacy, Tolerability, Health-Related Quality of Life

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.

Interventions

DRUGexemestane and pazopanib

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Progression free survival	—

Secondary

Measure	Time frame
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	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026