A Phase 2, Randomized, Open-label Study of Bosutinib Administered in Combination With Letrozole Versus Letrozole Alone as First Line Therapy in Post-Menopausal Women With Locally Advanced or Metastatic ER+/PgR+/erbB2- Breast Cancer

Wyeth Research Division of Wyeth Pharmaceuticals Inc0 个研究点目标入组 250 人开始时间: 2009年10月5日最近更新: 2013年2月4日

适应症

试验速览

暂无简介。

•· Surgically sterile or postmenopausal women.
•· Confirmed pathologic diagnosis of breast cancer.
•· Locally advanced, metastatic, or locoregional recurrent breast cancer 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.
•· At least 1 radiologically measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST).
•· Eastern Cooperative Oncology Group (ECOG) performance status 0 to 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) no
•F.1.3.1 Number of subjects for this age range

•· Prior letrozole (except in adjuvant setting), prior bosutinib, or any other prior anti-Src therapy.
•· Prior endocrine treatment for locally advanced or MBC.
•· More than 1 prior cytotoxic chemotherapy regimen in metastatic setting. (Subjects may have received prior adjuvant or neoadjuvant chemotherapy.)
•· Adjuvant AI therapy =12 months before day 1 of treatment.
•· Adjuvant tamoxifen therapy =2 weeks before day 1 of treatment.
•· Bone or skin as the only site of disease.
•· Major surgery or radiotherapy within 14 days of treatment day 1.
•· Extensive visceral disease or active central nervous system (CNS) disease.
•· Any other cancer within 5 years of screening with the exception of ER+ contralateral breast carcinoma, adequately treated cervical carcinoma in situ, or adequately treated basal or squamous cell carcinoma of the skin.
•· History of clinically significant or uncontrolled cardiac disease.
•· Serious concurrent illness.

发起方

Wyeth Research Division of Wyeth Pharmaceuticals Inc