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

NCT00651976 | Terminated Early Phase 1 DMC

• 5 other identifiers: VICC BRE 0776P50CA098131P30CA068485VU-VICC-BRE-0776VU-VICC-IRB-080064
• Study Type: interventional
• Target: 213
• Locations: 1 country
• Sites: 5

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 the tumor on a molecular level and determine markers of response to treatment. PURPOSE: This study will show us how well letrozole works in treating postmenopausal women with stage I, II or III breast cancer that can be removed by surgery.

Conditions

Breast Cancer

Keywords

stage IA breast cancer; stage IB breast cancer; stage II breast cancer; stage III breast cancer; HER2-negative breast cancer; estrogen receptor-positive breast cancer

Outcome Measures

Primary Outcomes (1)

• 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 tissue. The number of stained cells will be compared in tissue that is hormone receptor-positive tissue to tissue that is hormone receptor negative.

  day 7 to day 21

Secondary Outcomes (2)

• In situ apoptotic effect of letrozole

  day 7 to day 21

• Identification of a recurrence risk biomarker profile using RNA microarray

  day 7 to day 21

Study Arms (1)

treatment

EXPERIMENTAL

Drug: letrozole; Other: Blood Collection; Procedure: biopsy/lumpectomy/mastectomy

Interventions

letrozole DRUG

Take by mouth at a dose of 2.5 mg on days 7-21

treatment

Blood Collection OTHER

Blood used for gene expression analysis and reverse transcriptase-polymerase chain reaction

treatment

biopsy/lumpectomy/mastectomy PROCEDURE

Tissue collection,Surgery to remove tumor, Tumor tissues used for laboratory biomarker analysis

treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Vanderbilt-Ingram Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (5)

Emory University

Atlanta, Georgia, United States

Location

Surgical Associates, Inc.

Tulsa, Oklahoma, 74136, United States

Location

Allegheny Cancer Center

Pittsburgh, Pennsylvania, 15212, United States

Location

Vanderbilt-Ingram Cancer Center, One Hundred Oaks

Nashville, Tennessee, 37204, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

Related Links

• Vanderbilt-Ingram Cancer Center, Find a Clinical Trial

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Letrozole; Blood Specimen Collection; Biopsy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Cytodiagnosis; Cytological Techniques; Diagnostic Techniques, Surgical

Study Officials

• Ingrid Meszoely, MD

  Vanderbilt-Ingram Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Surgery (Surgical Oncology); Clinical Director, Vanderbilt Breast Center; Surgical Oncologist

Study Record Dates

• First Submitted: April 2, 2008
• First Posted: April 3, 2008
• Study Start: March 1, 2008
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: October 15, 2018

Record last verified: 2018-10

Locations

US (5)