Pre-Surgical Intervention for Targeted Therapies for Breast Cancer

• Status: Completed
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to determine the feasibility of a short term administration of a targeted therapy (i.e., anastrozole) in women with newly diagnosed early invasive or non invasive breast cancer during the interval between their breast biopsy and surgery. Anastrozole is a form of hormonal therapy which is part of the standard treatment for hormone sensitive breast cancer in postmenopausal women. This clinical model is being used to evaluate the biologic effects of this drug on a specific molecular pathway called the PI3K/AKT signaling pathway.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Columbia University
• Collaborator: Avon Foundation
• Treatments: Anastrozole

Criteria

Inclusion Criteria:

• Histologically-confirmed operable ER+ and/or PR+ invasive breast cancer or ductal carcinoma in situ (DCIS), who undergo core needle biopsy followed by surgical excision at least 2 weeks after enrollment

• Postmenopausal status defined as cessation of menses for >1 year or FSH > 20 mIU/mL (within the past month)

• Age ≥ 21 years

• No prior chemotherapy, radiation therapy, or surgery within 6 months of study entry

• Signed informed consent

Exclusion Criteria:

• Treatment with other investigational drugs within 6 months of study entry

• Other serious intercurrent medical illness