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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00615524
Recruitment Status : Withdrawn (Cancelled Before Enrollment)
First Posted : February 14, 2008
Last Update Posted : January 12, 2018
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Hormone-receptor Positive Breast Cancer Drug: exemestane and pazopanib Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : April 2008
Estimated Primary Completion Date : November 2012
Estimated Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Progression free survival

Secondary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00615524

United States, California
GSK Clinical Trials Call Center
San Francisco, California, United States, 94115
Sponsors and Collaborators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline

Responsible Party: GlaxoSmithKline Identifier: NCT00615524     History of Changes
Other Study ID Numbers: VEG108843
First Posted: February 14, 2008    Key Record Dates
Last Update Posted: January 12, 2018
Last Verified: January 2018

Keywords provided by GlaxoSmithKline:
Breast cancer
Health-Related Quality of Life

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists