CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 161 enrolled
Drug / intervention
Anastrozole +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04294225
NCT04294225Phase 2Completed
CompareCT.gov

Pharmacodynamic Study of Estrogen Suppression Threshold-Directed Therapy (ESTDT) of Anastrozole as Adjuvant Therapy for Early Stage Breast Cancer

Mayo Clinic·interventional·Posted Mar 4, 2020·Updated Jan 28, 2025

In Brief

A Phase 2 clinical trial evaluating Anastrozole and Letrozole for Anatomic Stage I Breast Cancer AJCC v8 and 21 related conditions. Completed, enrolled 161 participants across 3 sites.

Detailed Summary

This phase II trial studies how well anastrozole and letrozole after surgery work in treating patients with stage I-III breast cancer. Drugs, such as anastrozole and letrozole, may stop the growth of tumor cells by decreasing the amount of estrogen made by the body. Giving anastrozole and letrozole after surgery may prevent breast cancer from coming back (recurrence).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIB Breast Cancer AJCC v8, Anatomic Stage IIIC Breast Cancer AJCC v8, Early-Stage Breast Carcinoma, Invasive Breast Carcinoma, Prognostic Stage I Breast Cancer AJCC v8, Prognostic Stage IA Breast Cancer AJCC v8, Prognostic Stage IB Breast Cancer AJCC v8, Prognostic Stage II Breast Cancer AJCC v8, Prognostic Stage IIA Breast Cancer AJCC v8, Prognostic Stage IIB Breast Cancer AJCC v8, Prognostic Stage III Breast Cancer AJCC v8, Prognostic Stage IIIA Breast Cancer AJCC v8, Prognostic Stage IIIB Breast Cancer AJCC v8, Prognostic Stage IIIC Breast Cancer AJCC v8
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedMar 4, 2020
Enrollment StartApr 28, 2020
Primary CompletionDec 12, 2022
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 6.3 years ago

Interventions

Anastrozoledrug

Given PO

Letrozoledrug

Given PO