Overview

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