A Phase 2, Randomized, Open-label Study of Bosutinib Administered in Combination With Exemestane vs. Exemestane Alone as Second Line Therapy in Post-Menopausal Women with Locally Advanced or Metastatic ER+/PgR+/Her2- Breast Cancer

Wyeth Research Division of Wyeth Pharmaceuticals Inc.0 个研究点目标入组 194 人开始时间: 2008年11月21日最近更新: 2014年1月27日

适应症

试验速览

暂无简介。

•Post-menopausal women.
•Confirmed pathologic diagnosis of breast cancer.
•Locally advanced or metastatic, or loco-regional recurrent and not amenable to curative treatment with surgery or radiotherapy.
•Documented ER+ and/or PgR+ and erbB2- tumor based on most recently analyzed biopsy, as documented by a local laboratory.
•Progression of locally advanced or metastatic disease during treatment with a non-steroidal AI or tamoxifen, or progression during treatment with (or within 6 months of discontinuation of) an adjuvant non-steroidal AI.
•At least 1 radiologically measurable lesion as defined by RECIST
•ECOG performance status 0-2.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Prior exemestane, prior bosutinib, or any other prior Src inhibitor.
•More than 1 prior endocrine treatment for locally advanced or metastatic breast cancer.
•More than 1 prior chemotherapy regimen in metastatic setting
•Subjects with bone or skin as the only site of disease
•Extensive visceral disease or active CNS disease.
•Any other cancer within 5 years of screening with the exception of adequately treated cervical carcinoma in situ, or adequately treated basal or squamous cell carcinoma of the skin.
•Major surgery or radiotherapy within 14 days of treatment day 1.
•No adequate hepatic/renal/bone marrow function.
•History of clinically significant or uncontrolled cardiac disease
•Serious concurrent illness.

发起方

Wyeth Research Division of Wyeth Pharmaceuticals Inc.