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NCT07866430

PHASE2

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

Sponsor: Montefiore Medical Center

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - 59 Years

Study Type

INTERVENTIONAL

Enrollment

144

Start Date

2026-09

Completion Date

2032-12

Last Updated

2026-10-08

Healthy Volunteers

Conditions

Brest Cancer ER+ and HER2 Negative

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.

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 defined below: absolute neutrophil count ≥1,000/mcL platelets ≥100,000/mcL total bilirubin ≤ institutional upper limit of normal (ULN) AST(SGOT)/ALT(SGPT) ≤3 × institutional ULN creatinine ≤ institutional ULN Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants. Participants must not have received prior therapy for current breast cancer. Participants must be postmenopausal defined as any of the following: * Age ≥60 years * Age \<60 years with ≥12 months of spontaneous amenorrhea without chemotherapy, endocrine therapy, ovarian suppression, pregnancy, or lactation * Prior bilateral oophorectomy * Age \<60 years with hysterectomy and laboratory values in the postmenopausal range (elevated FSH and low estradiol) Exclusion Criteria: Participants who are candidates for neoadjuvant therapy. Participants who are receiving any other investigation agents. History of allergic reactions attributed to compounds of similar chemical or biologic composition to letrozole. Participants with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous. Male participants at birth History of severe osteoporosis (T score \< -4 either spine or hip), or presence of vertebral fracture.

Locations (1)

Montefiore Medical Center

The Bronx, New York, United States