Study Evaluating SKI-606 (Bosutinib) In Subjects With Breast Cancer

Pfizer

Status and phase: Completed; Phase 2

Conditions: Neoplasm Metastasis; Breast Neoplasms

Treatments: Drug: SKI-606 (Bosutinib)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00319254

3160A2-201

B1871014

Details and patient eligibility

About

The purpose of this study is to determine if SKI-606 (Bosutinib) is effective in the treatment of advanced or metastatic breast cancer. Patients must have current Stage IIIB, IIIC or IV breast cancer and have progressed after 1 to 3 prior chemotherapy regimens.

Enrollment: 75 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Stage IIIB, IIIC or IV breast cancer not curable with available therapy.
• Patients must have progressed after 1 but not more than 3 prior chemotherapy regimens.
• Life expectancy of at least 16 weeks.
• Ability to swallow whole capsules.

Exclusion criteria

• Use of or requirement for bisphosphonates within 8 weeks prior to screening.
• Any other cancer within 5 years of screening, except for basal cell carcinoma or cervical carcinoma in situ
• Uncontrolled cardiac disease including congestive heart failure, angina, heart attack, etc.
• Recent or ongoing significant gastrointestinal disorder

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

75 participants in 1 patient group

Advanced breast cancer

Experimental group

Treatment:

Drug: SKI-606 (Bosutinib)

Sponsor of this trial

Lead Sponsor

Pfizer