Recruiting
Phase 1

Letrozole SIE vs. Femara

Sponsor:

Rovi Pharmaceuticals Laboratories

Code:

NCT07401381

Conditions

Hormone Receptor Positive Early Breast Cancer

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

US-sourced oral Femara® + Letrozole SIE

EU sourced oral Femara® + Letrozole SIE

Study Details

Brief summary:

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.

Conditions

Hormone Receptor Positive Early Breast Cancer

Study ID

NCT07401381

Start date

Jun 8, 2026

Status verified date

Sep, 2026

Completion date

Oct, 2028

Anticipated

Primary completion date

May, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Women with weight of ≥50 kg and a Body Mass Index (BMI) ≥19 kg/m2 and ≤39 kg/m2
  • Postmenopausal women.
  • Women with confirmed diagnosis of HR+/HER2- or HR+/HER2+ early stage breast cancer who have completed at least 5 years of endocrine therapy, at least 2 years of which were with letrozole. Participants at a low risk of relapse, as assessed by the investigator, can also be eligible after completing 4 years of adjuvant endocrine therapy, at least 2 of which were with letrozole.
  • Women in good health.
  • Women who have undergone breast imaging per applicable guidelines (e.g., mammogram) within the last 12 months with no evidence of malignancy (documentation required), and if not done, must be willing to have 1 performed prior to baseline.

Exclusion Criteria:

  • Presence of an uncontrolled, unstable, clinically significant medical condition.
  • Have used estrogen or progesterone systemic or topical therapy, oral contraceptives, androgens, LH-releasing hormone analogs, prolactin inhibitors, or antiandrogens within 3 months prior to screening.
  • Use of inducers or inhibitors of CYP3A4 and CYP2A6.
  • Diagnosed with osteoporosis.
  • Preexisting cardiovascular disease
  • Positive result for hepatitis B surface antigen, hepatitis B core antibody, hepatitis C antibody, or HIV antibodies.

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: US-sourced oral Femara®

experimental: EU-sourced oral Femara®

Interventions

US-sourced oral Femara® + Letrozole SIE

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

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

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 and Locations

Central contacts

Clinical Operations. Laboratorios Farmacéuticos ROVI

+34913756230departamento.medico@rovi.es

Locations

Precision NextGen Oncology and Research Center (Investigational Site number USA-001)

Recruiting

Beverly Hills, California, United States, 90212

D&H National Research Centers INC (Investigational Site number USA-002)

Recruiting

Margate, Florida, United States, 33063

More Information

Sponsor

Rovi Pharmaceuticals Laboratories

Last update posted

Sep 11, 2026

Last verified

Sep, 2026

Keywords

  • Letrozole SIE
  • Early breast cancer
  • Pharmacokinetics
  • Bioavailability
  • Safety
  • Endocrine therapy
  • Injectable

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-12. This information was provided to ClinicalTrials.gov by Rovi Pharmaceuticals Laboratories on 2026-09-11.