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Sponsors and Collaborators: |
Vanderbilt-Ingram Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00651976 |
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by lowering the amount of estrogen the body makes. Giving letrozole before surgery may be an effective treatment for breast cancer.
PURPOSE: This phase I trial is studying how well letrozole works in treating postmenopausal women with stage I or stage II breast cancer that can be removed by surgery.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: letrozole Genetic: RNA analysis Genetic: gene expression analysis Genetic: reverse transcriptase-polymerase chain reaction Other: immunohistochemistry staining method Other: laboratory biomarker analysis Procedure: biopsy Procedure: neoadjuvant therapy Procedure: therapeutic conventional surgery |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Pre-Surgical Trial of Letrozole in Post-Menopausal Patients With Operable Hormone-Sensitive Breast Cancer (Spore) |
Estimated Enrollment: | 165 |
Study Start Date: | March 2008 |
Estimated Primary Completion Date: | March 2016 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive oral letrozole once daily for 14 days in the absence of disease progression or unacceptable toxicity. No more than 24 hours after the last dose of letrozole, patients undergo total mastectomy or segmental resection with lymph node evaluation.
Patients undergo tumor tissue biopsies at baseline and during surgical resection. 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).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of invasive breast cancer
Measurable disease, defined as a mass that can be reproducibly measured by physical examination and/or ultrasound and is at least 1 cm in size by ultrasound
Patients with locally advanced disease who are candidates for preoperative chemotherapy at the time of initial evaluation are not eligible
Locally advanced disease is defined by any of the following:
PATIENT CHARACTERISTICS:
Postmenopausal, as defined by any of the following:
Under 55 years of age and meets 1 of the following criteria:
PRIOR CONCURRENT THERAPY:
United States, Tennessee | |
Vanderbilt-Ingram Cancer Center - Cool Springs | Recruiting |
Nashville, Tennessee, United States, 37064 | |
Contact: Ingrid Meszoely 615-322-2391 | |
Vanderbilt-Ingram Cancer Center at Franklin | Recruiting |
Nashville, Tennessee, United States, 37064 | |
Contact: Ingrid Meszoely 615-322-2391 | |
Vanderbilt-Ingram Cancer Center | Recruiting |
Nashville, Tennessee, United States, 37232-6838 | |
Contact: Clinical Trials Office - Vanderbilt-Ingram Cancer Center 800-811-8480 |
Principal Investigator: | Ingrid Meszoely, MD | Vanderbilt-Ingram Cancer Center |
Study ID Numbers: | CDR0000592970, VU-VICC-BRE-0776, VU-VICC-IRB-080064 |
Study First Received: | April 2, 2008 |
Last Updated: | August 11, 2009 |
ClinicalTrials.gov Identifier: | NCT00651976 History of Changes |
Health Authority: | Unspecified |
stage I breast cancer stage II breast cancer |
Skin Diseases Breast Neoplasms Letrozole Aromatase Inhibitors |
Hormones Menopause Breast Diseases |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Skin Diseases Antineoplastic Agents Therapeutic Uses |
Breast Neoplasms Enzyme Inhibitors Letrozole Aromatase Inhibitors Pharmacologic Actions Breast Diseases |