De-EscaLaTion of Aromatase Inhibitor Therapy: A Randomized Phase II Study of De-escalated Letrozole in Hormone Receptor-Positive Early Breast Cancer (DELTA Trial)

Montefiore Medical Center

Summary

This study is a randomized, open-label, phase II trial designed to evaluate whether alternate-day dosing of letrozole preserves antiproliferative activity compared with standard daily dosing in postmenopausal women with estrogen receptor-positive, HER2-negative breast cancer.

Description

The objective of the study is to determine whether alternate-day dosing maintains suppression of tumor proliferation comparable to standard daily dosing. This study is designed to evaluate a dose de-escalation strategy using alternate-day letrozole dosing in patients with hormone receptor-positive breast cancer. By assessing short-term changes in Ki-67 following treatment, this study will determine whether reduced dosing maintains antiproliferative activity comparable to standard daily therapy. Demonstrating similar suppression of tumor proliferation with alternate-day dosing would provide imp…

Eligibility

Age range: 18–59 years
Sex: Female
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: * Participants must have histologically confirmed breast cancer, clinical stage I-III as per the AJCC 8th edition (Anatomic Prognostic Staging). Tumors must be estrogen receptor-positive (ER expression ≥ 10%) and HER2 negative (IHC 0-1+, or IHC 2+ with negative FISH). Tumors can be progesterone receptor positive or negative. Participants must be planned to undergo surgery upfront. Age ≥18 years. Participants must be postmenopausal female. ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A). Participants must have an adequate organ and marrow function as defin…

Interventions

Drug
Letrozole
This study is designed as a non-inferiority trial. Prior neoadjuvant endocrine therapy studies have demonstrated that short-term aromatase inhibitor therapy typically produces substantial reductions in tumor proliferation, with Ki-67 reductions of approximately 70-80% after several weeks of treatment.

Location

Montefiore Medical Center
The Bronx, New York
janampa@montefiore.org 7184058505

Description

Eligibility

Age range

18–59 years

Sex

Female

Healthy volunteers

Detailed criteria

Interventions

Drug

Letrozole

This study is designed as a non-inferiority trial. Prior neoadjuvant endocrine therapy studies have demonstrated that short-term aromatase inhibitor therapy typically produces substantial reductions in tumor proliferation, with Ki-67 reductions of approximately 70-80% after several weeks of treatment.