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Clinical Trial VICCBRE0776


Pre-Surgical Trial of Letrozole in Post-Menopausal Patients with Operable Hormone-Sensitive Breast Cancer (SPORE)

Principal Investigator(s)

Ingrid Meszoely


  • Protocol No. VICCBRE0776
  • Open Date: 03/24/2008
  • Staging: Phase 0
  • Age Group: Adults
  • Scope: Local
  • Objective: To determine whether Letrozole-induced reduction of Ki67 in patients with ER+/Her2- operable breast cancer correlates with the OncotypeDX assay recurrence score and to identify a recurrence risk biomarker profile with RNA microarray.
  • Disease Sites: Breast
  • Therapies: Hormonal Therapy
  • Drugs: Letrozole (Femara)
  • Participating Institutions: Vanderbilt University; Instituto Nacional de Enfermedades Neoplasicas; Allegheny Cancer Center; Bryn Mawr; Lankenau Hospital; Emory University; Surgical Associates, Inc. (Tulsa)
  • National Clinical Trial ID: NCT00651976
  • Secondary Protocol No: Femara (Letrozole) US64T


Patients are being asked to take part in this research study because they have breast cancer that is treatable with an operation. The cancer has special proteins on it that allow it to grow when exposed to estrogen, called estrogen receptors (ER). In addition to surgery, this type of cancer is often treated with a drug called an aromatase inhibitor (AI). These are drugs approved by the Federal Drug Administration (FDA). These drugs prevent testosterone from being converted to estrogen. This decreases the level of estrogen in the body. Thus the cancer is prevented from growing. However some cancers seem to be resistant or develop a resistance to this drug. In this situation cancers may grow despite taking the pill. This study will try to determine a method to find out which cancers are resistant or will become resistant to this type of treatment. This will allow us to tell which patients will benefit from the drug and which ones will not. This will allow doctors to better customize treatments for breast cancer. In addition, this study will analyze other molecules that may contribute to the treatment. If these can be identified, better drugs may be developed for the future.


Ages Eligible for Study:18 Years and older
Genders Eligible for Study:Female
Accepts Healthy Volunteers:No


• Diagnosis of invasive breast cancer
• Clinical stage I, II, or III disease
• Resectable disease
• 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 measurable residual tumor at the primary site allowed
• Estrogen receptor-positive tumor by immunohistochemistry (IHC)
• HER2-negative tumor by Herceptest (0 or +1) OR HER2 not overexpressed by fluorescence in situ hybridization (FISH)
• Planning to undergo surgical treatment with either segmental resection or total mastectomy with or without lymph node evaluation
• Must have core biopsies from the time of diagnosis available (may include sections of paraffin-embedded material)
• Prior contralateral breast cancer allowed provided there is no evidence of recurrence of the initial primary breast cancer
• 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:
• Primary tumor ≥ 5 cm (T3)
• Tumor of any size with direct extension to the chest wall or skin (T4a-c)
• Inflammatory breast cancer (T4d)
• Fixed axillary lymph node metastases (N2)
• Metastasis to ipsilateral internal mammary node (N3)
• No locally recurrent disease
• No evidence of distant metastatic disease (i.e., lung, liver, bone, or brain metastases)
• ECOG performance status 0-1
• Postmenopausal, as defined by any of the following:
• 55 years of age and over
• Under 55 years of age and meets 1 of the following criteria:
• Amenorrheic for at least 12 months
• Follicle-stimulating hormone (FSH) ≥ 40 IU/L and estradiol levels ≤ 20 IU/L
• Has undergone prior bilateral oophorectomy or radiation castration AND has been amenorrheic for at least 6 months
• Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• SGOT and SGPT ≤ 1.5 times ULN
• Creatinine ≤ 1.5 t times ULN
• Able to swallow and retain oral medication
• No serious medical illness that, in the judgment of the treating physician, places the patient at high risk for operative mortality
• No malabsorption syndrome, ulcerative colitis, or other disease significantly affecting gastrointestinal function
• No other malignancy within the past 5 years except for completely resected nonmelanoma skin cancer or successfully treated in situ carcinoma
• No dementia, altered mental status, or any psychiatric condition that would preclude the understanding or rendering of informed consent
• No severe uncontrolled malabsorption condition or disease (i.e., grade II/III diarrhea, severe malnutrition, or short gut syndrome)
• See Disease Characteristics
• At least 21 days since prior tamoxifen or raloxifene as a preventive agent
• At least 7 days since prior hormone replacement therapy (e.g., conjugated estrogens [Premarin])
• No prior resection of the stomach or small bowel
• More than 30 days or 5 half-lives, whichever is longer, since prior investigational drugs
• No prior chemotherapy for this primary breast cancer
• No other concurrent investigational agents
• No other concurrent anticancer therapy (e.g., chemotherapy, radiotherapy, immunotherapy, hormonal therapy, or any other biologic therapy)