A Study to Compare the Steady-State Bioavailability of Injectable Letrozole SIE and Oral Letrozole in Post-Menopausal Women With Hormone Receptor Positive Early Breast Cancer

Conditions

• Hormone Receptor Positive Early Breast Cancer

Eligibility Criteria

Sex

FEMALE

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• US-sourced oral Femara® + Letrozole SIE — DRUG
  US-sourced Femara® 2.5 mg/day oral for 14 days (treatment period 1) + quarterly injectable Letrozole SIE (treatment period 2)
• EU sourced oral Femara® + Letrozole SIE — DRUG
  EU-sourced oral Femara® 2.5 mg/day for 14 days (treatment period 1) + quarterly injectable Letrozole SIE (treatment period 2)

Study Details

The study aims to compare the amount of the drug letrozole that gets into the bloodstream after multiple doses of the quarterly injection Letrozole SIE, versus multiple doses of the standard oral daily tablet of letrozole (Femara®), in women who have gone through menopause and have received treatment for hormone receptor-positive early breast cancer. Participants must have completed at least five years of hormone therapy with at least two of those years with letrozole before starting their participation in the study. Women who have completed four years of hormone therapy are also eligible if their doctor considers them at low risk of cancer returning.

Key Dates

First listed

Feb 10, 2026

Start date

Jun 8, 2026

Status verified

Sep 2026

Primary completion

May 31, 2028

Completion

Oct 31, 2028

Study Design

Enrollment

120 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: US-sourced oral Femara®
• Experimental: EU-sourced oral Femara®

Primary Outcome Measure

Area under the concentration-time curve within a dosing interval at Steady-State (SS AUCtau) [ Time Frame: After multiple doses of Letrozole SIE until Day 281 TP2 and after multiple doses of US-sourced oral Femara® or EU-sourced oral Femara® on Day 14 TP1 ]

Central Contacts

• Clinical Operations. Laboratorios Farmacéuticos ROVI
  +34913756230
  [email protected]

Locations (2)

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