Clinical Trials Logo

Clinical Trial Summary

This phase II trial examines letrozole in patients with newly diagnosed hormone receptor-positive HER2-negative invasive breast cancer that can be removed by surgery (operable). Letrozole is in a class of medications called nonsteroidal aromatase inhibitors. It works by decreasing the amount of estrogen produced by the body. This can slow or stop the growth of some types of breast cancer cells that need estrogen to grow.


Clinical Trial Description

PRIMARY OBJECTIVE: I. To comprehensively evaluate differences in tumor microenvironment subpopulations in aromatase inhibitor (AI)-sensitive versus (vs.) AI-resistant hormone receptor (HR)+ breast cancer. SECONDARY OBJECTIVES: I. To assess the effects of estrogen deprivation on the systemic immune response. II. To assess the effects of estrogen deprivation on tumor immune microenvironment. OUTLINE: Patients receive letrozole orally (PO) once daily (QD) for 2-8 weeks prior to surgery in the absence of disease progression or unacceptable toxicity. Patients then undergo collection of blood and tissue samples. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05447910
Study type Interventional
Source Mayo Clinic
Contact
Status Recruiting
Phase Phase 2
Start date July 21, 2022
Completion date June 15, 2025

See also
  Status Clinical Trial Phase
Recruiting NCT05059444 - ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation
Recruiting NCT04521764 - A Vaccine (MV-s-NAP) for the Treatment of Patients With Invasive Metastatic Breast Cancer Phase 1
Completed NCT02689427 - Enzalutamide and Paclitaxel Before Surgery in Treating Patients With Stage I-III Androgen Receptor-Positive Triple-Negative Breast Cancer Phase 2
Terminated NCT00148720 - Capecitabine in Women With Operable Breast Cancer Phase 2
Recruiting NCT05464810 - Letrozole With and Without Simvastatin for the Treatment of Stage I-III Hormone Receptor Positive, HER2 Negative Breast Cancer Early Phase 1
Suspended NCT03737695 - Clinical Information and Biospecimen Collection From Patients With Recurrent or Stage IV Breast Cancer
Recruiting NCT05406232 - Temporal Immunologic Changes With Hypofractionated Radiation-Induced DNA Damage in Breast Cancer
Withdrawn NCT03238703 - Endocrine Therapy in Treating Patients With HER2 Negative, Low Risk Breast Cancer Phase 4
Completed NCT03679559 - Exercise in Improving Health and Quality of Life in Breast Cancer Survivors N/A
Active, not recruiting NCT02876107 - Carboplatin and Paclitaxel With or Without Panitumumab in Treating Patients With Invasive Triple Negative Breast Cancer Phase 2
Active, not recruiting NCT02445391 - Platinum in Treating Patients With Residual Triple-Negative Breast Cancer Following Neoadjuvant Chemotherapy Phase 3
Completed NCT01964924 - Trametinib and Akt Inhibitor GSK2141795 in Treating Patients With Metastatic Triple-Negative Breast Cancer Phase 2
Recruiting NCT02276443 - Molecular Testing and Imaging in Improving Response in Patients With Stage I-III Triple-Negative Breast Cancer Receiving Chemotherapy MDACC Breast Moonshot Initiative N/A
Recruiting NCT05545150 - Volumetric Specimen Imager Device for the Intraoperative Imaging of Patients With Breast Carcinoma and Breast Ductal Carcinoma In Situ, The VIVID Study Phase 2
Active, not recruiting NCT03359954 - Radiation Therapy Before Surgery in Treating Patients With Hormone Receptor Positive, HER2 Negative Breast Cancer Phase 2
Active, not recruiting NCT01245712 - Radiation Therapy in Treating Patients With Stage 0-II Breast Cancer Phase 2
Active, not recruiting NCT05012176 - An Episodic Future Thinking Intervention to Promote Weight Loss in Breast Cancer Survivors N/A
Active, not recruiting NCT01334021 - Genetic Testing in Predicting Tumor Response in Patients With Stage I-III HER2 Negative Invasive Breast Cancer Phase 2
Completed NCT05071677 - Treatment Decision Making in African American Women Diagnosed With Triple Negative Breast Cancer
Recruiting NCT04169542 - Impact of COVID-19 Pandemic on Out-of-Pocket Costs, Lost Wages, and Unemployment in Patients With Breast Cancer Undergoing Breast Surgery