Study Evaluating Bosutinib-Exemestane Combination Vs Exemestane Alone in Post Menopausal Women With Breast Cancer

• Drug: Bosutinib
  
  300 mg =(3x100mg) tablets once daily during the active phase of treatment until disease progression, unacceptable toxicity or withdrawal of consent occurs
• Drug: exemestane
  
  25 mg tablet once daily
• Drug: Exemestane
  
  25 mg - 1 tablet per day- once daily daily during the active phase of treatment until disease progression, unacceptable toxicity or withdrawal of consent occurs

• Experimental: 1
  
  combination of bosutinib and exemestane
  Interventions:
  

  • Drug: Bosutinib
  • Drug: exemestane
• Active Comparator: 2
  
  exemestane
  Intervention: Drug: Exemestane

Inclusion Criteria:

• Woman aged 18 years or older.
• Confirmed pathologic diagnosis of breast cancer.
• Locally advanced, metastatic, or locoregional recurrent breast cancer not amenable to curative treatment with surgery or radiotherapy.
• Surgically sterile or postmenopausal woman.
• Documented ER+ and/or PgR+ and erbB2- tumor.
• 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.

Exclusion Criteria:

• Prior exemestane, prior bosutinib, or any other prior anti-Src therapy.
• More than 1 prior endocrine treatment for locally advanced or MBC.
• More than 1 prior cytotoxic chemotherapy regimen in metastatic setting.
• Bone or skin as the only site of disease.