CALGB 40903: Phase II Study of Neoadjuvant Letrozole for Postmenopausal Women with Estrogen Receptor Positive Ductal Carcinomas in Situ (DCIS)

Service: Trial Number:
112-12
Principal Investigator: Conducted at:
Long Beach Memorial, Orange Coast Memorial
Currently enrolling additional patients:
Yes

Currently, the standard treatment for ductal carcinoma in situ (DCIS) (an early change in the breast that could possibly become breast cancer in the future) is surgery followed by radiation therapy. However, the purpose of this study is to test if the neoadjuvant treatment (given before surgery) with the aromatase inhibitor letrozole (anti-hormonal medication) has a positive or negative effect on the patient and the DCIS. The aromatase inhibitor letrozole is approved by the Food and Drug Administration (FDA) for postmenopausal patients whose tumors are estrogen positive. Eligible, consenting participants will begin taking letrozole within 14 days of registration. They will orally take a dose of 2.5 mg/day for potentially 6 months. Subjects will have a bilateral MRI at months 3 and 6 to evaluate the disease. These MRIs are considered to be part of research. If the DCIS gets larger by month 3, the subject will be scheduled for surgery within 30 days of the MRI review. Subjects who have a stable or partial response (DCIS staying the same or getting smaller) will continue for the next 3 months and then get another bilateral MRI on the 6th month. Surgery will then be planned within 30 days of the final MRI. All subjects who understand English will be asked if they want to participate in a voluntary sub-study that consists of taking a Quality of Life survey before the study, at the 3 month clinic visit, at the 6 month clinic visit, and lastly either 6 months after surgery to remove DCIS or 6 months after the subject has stopped taking letrozole if they do not have surgery.

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