Pre-Surgical Trial of Letrozole in Post-Menopausal Patients With Operable Hormone-Sensitive Breast Cancer (Spore)
- To determine whether letrozole-induced reduction of Ki67 in postmenopausal women with
estrogen receptor (ER)-positive and HER2-negative, resectable, stage I, II, or III
breast cancer correlates with the OncotypeDX assay recurrence score.
- To identify a recurrence risk biomarker profile using RNA microarray.
- To determine the in situ apoptotic effect of letrozole in these patients.
- To correlate the in situ apoptotic effect of letrozole with OncotypeDX assay recurrence
score and RNA profiles.
OUTLINE: Patients receive oral letrozole once daily for 7-21 days in the absence of disease
progression or unacceptable toxicity. Within 24 hours after the last dose of letrozole,
patients undergo total mastectomy or segmental resection with lymph node evaluation.
Pre-treatment diagnostic breast tissue is obtained. Patients undergo treatment and then
undergo standard of care mastectomy or lumpectomy. Pre and post treatment tumor tissue
samples are analyzed for Ki67 and caspase 3 by immunohistochemistry; RNA microarray; and
OncotypeDX assay (a reverse transcriptase-polymerase chain reaction [RT-PCR] assay of 21
prospectively selected genes).
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Ki67 index measured in hormone receptor-positive breast cancers compared to those that are hormone receptor-negative
Ki67 index is measured by counting the percentage of cells staining for Ki67 in a section of breast tisse. The number of stained cells will be compared in tissue that is hormone receptor-postive tissue to tissue that is hormone receptor negative.
day 7 to day 21
Ingrid Meszoely, MD
Vanderbilt-Ingram Cancer Center
United States: Food and Drug Administration
VICC BRE 0776
|Vanderbilt-Ingram Cancer Center||Nashville, Tennessee 37232-6838|
|Emory University||Atlanta, Georgia 30322|
|Lankenau Hospital||Wynnewood, Pennsylvania 19096|
|Allegheny Cancer Center||Pittsburgh, Pennsylvania 15212-4772|
|Vanderbilt-Ingram Cancer Center at Franklin||Nashville, Tennessee 37064|
|Surgical Associates, Inc. (Tulsa)||Tulsa, Oklahoma 74136|
|Bryn Mawr||Wynnewood, Pennsylvania 19010|
|Vanderbilt-Ingram Cancer Center, One Hundred Oaks||Nashville, Tennessee 37204|