Study Evaluating Bosutinib-Exemestane Combination Vs Exemestane Alone in Post Menopausal Women With Breast Cancer
- Conditions
- Health Condition 1: null- Locally Advanced or Metastatic Breast Cancer
- Registration Number
- CTRI/2009/091/000362
- Lead Sponsor
- Wyeth Research Wyeth Pharmaceuticals India Private Limited A Subsidiary of Pfizer Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 164
1. Woman aged 18 years or older.
2.Confirmed pathologic diagnosis of breast cancer.
3.Locally advanced, metastatic, or locoregional recurrent breast cancer not amenable to curative treatment with surgery or radiotherapy.
4.Surgically sterile or postmenopausal woman.
5.Documented ER+ and/or PgR+ and erbB2- tumor.
6.Progression of locally advanced or metastatic disease during treatment with a nonsteroidal AI or tamoxifen, or progression during treatment with (or within 6 months of discontinuation of) an adjuvant nonsteroidal AI.
1) Prior exemestane, prior bosutinib, or any other prior anti-Src therapy.
2) More than 1 prior endocrine treatment for locally advanced or MBC.
3) More than 1 prior cytotoxic chemotherapy regimen in metastatic setting.
4) Bone or skin as the only site of disease.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare PFS assessed by an independent radiology vendor, of bosutinib in combination with exemestane versus exemestane alone as second line treatment for ER+/PgR+/ erbB2- advanced or metastatic breast cancer in postmenopausal women.Timepoint: 6 months
- Secondary Outcome Measures
Name Time Method To evaluate the safety profile of bosutinib-exemestane combo, to evaluate the combo PK, and exemestane alone PK, to evaluate efficacy parameters Overall Response Rate, Overall Survival at 2 years, response duration, Progression Free Survival, and to examine the healthrelated quality of life.Timepoint: 2 years