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Completed Phase 3 Interventional Results available

Letrozole in Preventing Cancer in Postmenopausal Women Who Have Received 4-6 Years of Hormone Therapy for Hormone Receptor-Positive, Lymph Node-Positive, Early-Stage Breast Cancer

ClinicalTrials.gov ID: NCT00553410

Public ClinicalTrials.gov record NCT00553410. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 21, 2026, 12:39 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

SOLE, Study of Letrozole Extension, A Phase III Trial Evaluating the Role of Continuous Letrozole Versus Intermittent Letrozole Following 4 to 6 Years of Prior Adjuvant Endocrine Therapy for Postmenopausal Women With Hormone-Receptor Positive, Node Positive Early Stage Breast Cancer

Study identification

NCT ID
NCT00553410
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
ETOP IBCSG Partners Foundation
Network
Enrollment
4,884 participants

Conditions and interventions

Conditions

Interventions

  • Letrozole Drug

Drug

Eligibility (public fields only)

Age range
18 Years to 120 Years
Sex
Female
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 31, 2007
Primary completion
Mar 31, 2018
Completion
May 14, 2019
Last update posted
Mar 10, 2020

2007 – 2019

United States locations

U.S. sites
2
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute Boston Massachusetts 02115
Faulkner Hospital Boston Massachusetts 02130-3400

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 162 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00553410, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 10, 2020 · Synced Jul 21, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00553410 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →