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

Conditions

• Brest Cancer ER+ and HER2 Negative

Eligibility Criteria

Sex

FEMALE

Age

18 Years - 59 Years

Healthy Volunteers

Not accepted

Interventions

• Letrozole — DRUG
  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.

Study Details

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.

Key Dates

First listed

Oct 8, 2026

Start date

Sep 30, 2026

Status verified

Aug 2026

Primary completion

Oct 31, 2032

Completion

Dec 31, 2032

Study Design

Enrollment

144 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Arm A (letrozole standard dosing)
  letrozole 2.5 mg orally once daily
• Experimental: Arm B (letrozole de-escalated dosing)
  letrozole 2.5 mg orally every other day

Primary Outcome Measure

Tumor proliferation measured by ki67 [ Time Frame: from baseline and up to 6 weeks of study treatment ]

Central Contacts

• Jesus Anampa, MD
  7184058505
  [email protected]
• Akash Shah
  7184058505
  [email protected]

Locations (1)

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