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

GlaxoSmithKline (GSK)

Status and phase

Withdrawn

Phase 2

Conditions

Hormone-receptor Positive Breast Cancer

Treatments

Drug: exemestane and pazopanib

Study type

Interventional

Funder types

Industry

Identifiers

NCT00615524

VEG108843

Details and patient eligibility

About

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.

Sex

Female

Ages

18+ years old

Volunteers

No 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.