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Status:

TERMINATED

Letrozole in Treating Postmenopausal Women With Stage I, II or III Breast Cancer That Can Be Removed by Surgery

Lead Sponsor:

Vanderbilt-Ingram Cancer Center

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Breast Cancer

Eligibility:

FEMALE

18+ years

Phase:

EARLY_PHASE1

Brief Summary

RATIONALE: Hormone therapy using letrozole may fight breast cancer by lowering the amount of estrogen the body makes. Giving letrozole before surgery allows us to monitor the effects of letrozole on t...

Detailed Description

OBJECTIVES: Primary To determine that in breast tumors that continue to exhibit high proliferation (i.e., Ki67) upon hormone deprivation (with letrozole), their gene expression and/or a mutational or...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • 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)
  • PATIENT CHARACTERISTICS:
  • 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)
  • PRIOR CONCURRENT THERAPY:
  • 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)

Exclusion

    Key Trial Info

    Start Date :

    March 1 2008

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    September 1 2018

    Estimated Enrollment :

    213 Patients enrolled

    Trial Details

    Trial ID

    NCT00651976

    Start Date

    March 1 2008

    End Date

    September 1 2018

    Last Update

    October 15 2018

    Active Locations (5)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 2 (5 locations)

    1

    Emory University

    Atlanta, Georgia, United States

    2

    Surgical Associates, Inc.

    Tulsa, Oklahoma, United States, 74136

    3

    Allegheny Cancer Center

    Pittsburgh, Pennsylvania, United States, 15212

    4

    Vanderbilt-Ingram Cancer Center, One Hundred Oaks

    Nashville, Tennessee, United States, 37204