Clinical Trials Logo

Clinical Trial Summary

This randomized phase I trial studies the side effects and the best dose of letrozole in preventing breast cancer in healthy postmenopausal women at high risk for breast cancer. Chemoprevention is the use of drugs to keep breast cancer from forming or coming back. The use of letrozole may keep cancer from forming in healthy postmenopausal women at high risk for breast cancer.


Clinical Trial Description

PRIMARY OBJECTIVES:

I. Compare the effect of lower and intermittent doses of letrozole to standard letrozole therapy on estrogen suppression in postmenopausal women at high risk for developing breast cancer.

SECONDARY OBJECTIVES:

I. Comparison of the effect of lower and intermittent doses of letrozole to standard therapy on signs and symptoms of estrogen deficiency, including menopausal symptoms, serum lipid profile, and serum marker of bone turnover.

II. Comparison of the effect of lower and intermittent doses of letrozole to standard therapy on nuclear chromatin abnormality of breast epithelial cells collected by random periareolar fine needle aspiration (RPFNA).

TERTIARY OBJECTIVES:

I. Determine the prevalence of breast cancer stem cells in the fine needle breast aspirates and explore the potential intervention effect on the prevalence of breast cancer stem cells.

OUTLINE: Patients are randomized to 1 of 4 treatment arms.

ARM I: Patients receive 2.5 mg of letrozole orally (PO) thrice weekly for 6 months.

ARM II: Patients receive 1.0 mg of letrozole PO thrice weekly for 6 months.

ARM III: Patients receive 0.25 mg of letrozole PO thrice weekly for 6 months.

ARM IV: Patients receive 2.5 mg of letrozole PO once daily for 6 months.

After completion of study treatment, patients are followed up at week 30. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention


Related Conditions & MeSH terms


NCT number NCT01077453
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Completed
Phase Phase 1
Start date March 2010

See also
  Status Clinical Trial Phase
Completed NCT01950403 - Linaclotide Acetate in Preventing Colorectal Cancer in Healthy Volunteers Phase 1
Terminated NCT01561989 - Cholecalciferol and Flu Vaccine in Treating Healthy Participants N/A
Terminated NCT01336387 - Dose-Finding of Retinoid 9cUAB30 in Healthy Volunteers Phase 1
Completed NCT01140646 - Evaluation of SAMe for Hot Flashes Phase 2
Completed NCT00892515 - Exercise Programs in Healthy Young Women at Increased Risk of Developing Breast Cancer N/A
Completed NCT00450957 - Lycopene in Healthy Male Participants Phase 1
Completed NCT00365209 - Phase II A Trial of Curcumin Among Patients With Prevalent Subclinical Neoplastic Lesions (Aberrant Crypt Foci) Phase 2
Recruiting NCT04445532 - Hepatobiliary Tumors Tissue Samples Acquisition
Completed NCT02100254 - Narrative or Fact-Based Videos in Increasing Colorectal Cancer Screenings in African American Communities N/A
Completed NCT02129517 - Web-Based Tailored Educational Program in Improving Nurse Communication With Patients About Clinical Trials N/A
Terminated NCT01755208 - Light-Scattering Spectroscopy for Detection of Breast Cancer N/A
Completed NCT00392652 - Diindolylmethane in Healthy Volunteers Phase 1
Completed NCT00499460 - Effects of Garlic Supplements on Opioids in Healthy Volunteers Phase 4
Completed NCT00478309 - Genetic Epidemiology Risk Assessment Program or Usual Care in Colorectal Cancer Screening for Healthy Participants N/A
Completed NCT01370889 - Resveratrol in Postmenopausal Women With High Body Mass Index Phase 1
Completed NCT00896207 - Studying Different Formulations of SR13668 in Healthy Volunteers Phase 1
Completed NCT00679094 - Bowman-Birk Inhibitor Concentrate in Healthy Men Phase 1
Terminated NCT02154984 - Time Restricted Diet in Obese or Overweight Pre or Postmenopausal Participants N/A
Completed NCT00489372 - Se-Methyl-Seleno-L- Cysteine (MSC) in Treating Healthy Patients Phase 1
Completed NCT00513916 - Effect of Dietary Soy on Estrogens in Breast Fluid, Blood, and Urine Samples From Healthy Women Phase 3