Completed

A Phase 2 Trial Of 4 Months Preoperative Letrozole 2.5 mg Daily For Postmenopausal Women With Estrogen Receptor Positive And/Or Progesterone Receptor Positive T2, T3, T4a-c, N0-2, M0 Breast Cancer- Novel Biomarkers for Aromatase Inhibitor Therapy

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What is being tested

letrozole

+ conventional surgery
Drug
Procedure
Who is being recruted

Breast Diseases
+2

+ Breast Neoplasms
+ Neoplasms
Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: October 2003
See protocol details

Summary

Principal SponsorWashington University School of Medicine
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: October 1, 2003Actual date on which the first participant was enrolled.

OBJECTIVES: Primary * Develop a predictive model of response (based on gene expression profiling) in postmenopausal women with estrogen- and/or progesterone-receptor positive stage II, IIIA, or IIIB breast cancer treated with neoadjuvant letrozole. Secondary * Determine the response rate in patients treated with this drug. * Determine changes in Ki67 proliferation rates in patients treated with this drug. * Determine the rate of improvement in surgical outcomes in patients treated with this drug. * Determine the long-term outcomes in patients treated with this drug. * Determine the safety of this drug in these patients. * Determine mechanisms of resistance to this drug in these patients. OUTLINE: This is a multicenter study. Patients receive neoadjuvant oral letrozole once daily for 16 weeks in the absence of disease progression. Patients then undergo breast surgery one day after the last dose of letrozole. Patients with partial response after 16 weeks may continue to receive letrozole for an additional 8 weeks before undergoing breast surgery. Patients are followed within 4 weeks after definitive surgery and then annually for 10 years. PROJECTED ACCRUAL: A total of 150 patients will be accrued for this study.

Official TitleA Phase 2 Trial Of 4 Months Preoperative Letrozole 2.5 mg Daily For Postmenopausal Women With Estrogen Receptor Positive And/Or Progesterone Receptor Positive T2, T3, T4a-c, N0-2, M0 Breast Cancer- Novel Biomarkers for Aromatase Inhibitor Therapy 
NCT00084396
Principal SponsorWashington University School of Medicine
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
115 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled
: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
FemaleBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Breast Diseases
Breast Neoplasms
Neoplasms
Neoplasms by Site
Skin Diseases
Criteria

DISEASE CHARACTERISTICS: * Histologically confirmed infiltrating adenocarcinoma of the breast by core needle biopsy * Clinical stage T2-T4a-c, N0-2, M0 * Palpable and measurable disease * Previously untreated disease * Benefits from neoadjuvant therapy that would improve surgical outcome AND meets criteria for 1 of the following: * Marginal candidate for lumpectomy (e.g., lumpectomy feasible but patient at risk for positive margins or poor cosmetic outcome) AND patient desires breast-conserving surgery * Ineligible for lumpectomy due to size of primary tumor, but modified radical mastectomy feasible AND patient desires breast-conserving surgery * Inoperable disease AND systemic therapy required for disease to become operable by modified radical mastectomy * Bilateral primary tumors allowed provided both tumors are consistent with entry criteria * No inflammatory carcinoma (defined as peau d' orange affecting at least one third of the breast) * Direct extension of the tumor to the skin allowed * No metastatic breast disease, except isolated ipsilateral supraclavicular lymphadenopathy * Hormone receptor status: * Estrogen- and/or progesterone-receptor positive disease based on 10% or more nuclear staining of the invasive component of the tumor PATIENT CHARACTERISTICS: Age * Postmenopausal Sex * Female Menopausal status * Postmenopausal, defined as meeting 1 of the following criteria: * Cessation of menstrual periods for at least 1 year * Bilateral surgical oophorectomy * Follicle-stimulating hormone and estradiol levels in the postmenopausal range Performance status * ECOG 0-2 Life expectancy * Not specified Hematopoietic * Not specified Hepatic * No severe liver dysfunction that would preclude study participation Renal * Not specified Other * Willing and able to provide biopsy material * Willing to undergo breast surgery after neoadjuvant treatment * No condition (e.g., confusion, infirmity, or alcoholism) that would preclude study compliance * No other concurrent active and progressive invasive malignancies * No other concurrent severe disease that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent immunotherapy or biological response modifiers for breast cancer Chemotherapy * No prior chemotherapy for breast cancer * No concurrent chemotherapy for breast cancer Endocrine therapy * At least 2 weeks since prior hormone replacement therapy or phytoestrogenic herbal, alternative, or over-the-counter (OTC) sex hormone remedies * No prior hormonal agents for breast cancer * No prior aromatase inhibitors, tamoxifen, raloxifene, or other antiestrogen or selective estrogen receptor modulators * No concurrent drugs known to affect sex hormone status, including hormone replacement therapy or phytoestrogenic herbal, alternative, or OTC remedies * No other concurrent endocrine therapy for breast cancer Radiotherapy * No prior radiotherapy for breast cancer * No concurrent radiotherapy for breast cancer Surgery * Prior sentinel node biopsy allowed * No other concurrent surgery for breast cancer Other * More than 30 days since prior non-approved or experimental drugs * Concurrent bisphosphonates for osteoporosis allowed * No other concurrent treatment for breast cancer

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental

Study Objectives
Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
Washington University School of MedicineSaint Louis, United StatesSee the location
CompletedOne Study Center