Pre-Surgical Intervention for Targeted Therapies for Breast Cancer

Completed · Not applicable

Conditions studied: Invasive Breast Cancer

In brief

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.

Key facts

Study ID

NCT01004744

Run by

Columbia University

People needed

10

Starts

2007-07-01

Expected to finish

2009-08-01

Last updated by the study team

2021-01-11

Who can join

Age: 21 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Treatment with other investigational drugs within 6 months of study entry
• Other serious intercurrent medical illness

Where it is running

• Columbia University Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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