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Uno studio per confrontare la biodisponibilità allo stato stazionario del letrozolo iniettabile SIE e del letrozolo orale in donne in post-menopausa con carcinoma mammario precoce positivo ai recettori ormonali (SIE-1)

8 ottobre 2026 aggiornato da: Rovi Pharmaceuticals Laboratories

Uno studio in aperto, a sequenza unica, per valutare la biodisponibilità comparativa allo stato stazionario del letrozolo trimestrale SIE e del letrozolo orale 2,5 mg una volta al giorno (Femara®) in donne in post-menopausa trattate con terapia endocrina per carcinoma mammario precoce positivo ai recettori ormonali. (SIE-1)

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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

The primary objective of the study is to evaluate the steady-state comparative bioavailability of quarterly injectable Letrozole SIE compared to United States (US)-sourced oral Femara® in the US-sourced arm and of quarterly injectable Letrozole SIE compared to European Union (EU)-sourced oral Femara® in the EU-sourced arm, in post-menopausal women treated with endocrine therapy for hormone-receptor positive (HR+) early breast cancer (EBC). The study also aims to characterize the elimination phase of Letrozole SIE after multiple doses.

The study consists of four periods: Screening, Treatment Period 1 (TP1), Treatment Period 2 (TP2) and Extension Period. After the Screening Period, participants will be randomized to two different arms: US-sourced oral Femara® or EU-sourced oral Femara® for 14 days to achieve the steady-state concentrations of letrozole in TP1. After receiving the latest oral letrozole dose, participants from both arms will start TP2. In TP2, quarterly injectable Letrozole SIE will be administered to achieve steady-state. After TP2, a subset of participants (up to 60 participants, regardless of which study arm they belong to) will continue in the study for the assessment of the elimination phase of Letrozole SIE after multiple doses during the Extension Period.

It is estimated that approximately 120 subjects should be randomized.

Tipo di studio

Interventistico

Iscrizione (Stimato)

120

Fase

  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Serbia
      • Belgrade, Serbia, 11000
        • Reclutamento
        • Investigational Site number SRB-004
      • Belgrade, Serbia, 11080
        • Reclutamento
        • Investigational Site number SRB-002
      • Kamenitz, Serbia, 21204
        • Reclutamento
        • Investigational Site number SRB-001
      • Kragujevac, Serbia, 34000
        • Reclutamento
        • Investigational Site number SRB-003
      • Niš, Serbia, 18000
        • Reclutamento
        • Investigational Site number SRB-005
  • Spagna
      • Alcorcón, Spagna, 28922
        • Reclutamento
        • Hospital Universitario Fundación Alcorcón (Investigational Site number ESP-015)
      • Barcelona, Spagna, 08023
        • Reclutamento
        • NEXT Oncology. Phase I Unit / IOB - Hospital Quironsalud Barcelona (Investigational Site number ESP-002)
      • Granada, Spagna, 18014
        • Reclutamento
        • Hospital Universitario Virgen de las Nieves (Investigational Site number ESP-011)
      • Jaén, Spagna, 23007
        • Reclutamento
        • Hospital Universitario de Jaén (HUJ) (Investigational Site number ESP-005)
      • León, Spagna, 24071
        • Reclutamento
        • Complejo Asistencial Universitario de León - Hospital de León (Investigational Site number ESP-013)
      • Lleida, Spagna, 25198
        • Reclutamento
        • Hospital Universitario Arnau de Vilanova de Lleida (Investigational Site number ESP-003)
      • Manresa, Spagna, 08243
        • Reclutamento
        • Althaia Xarxa Assistencial Universitària de Manresa F.P (Investigational Site number ESP-012)
      • Murcia, Spagna, 30120
        • Reclutamento
        • Hospital Clínico Universitario Virgen de la Arrixaca (Investigational Site number ESP-009)
      • Málaga, Spagna, 29004
        • Reclutamento
        • Hospital Quirónsalud Málaga (Investigational Site number ESP-001)
      • Pozuelo de Alarcón, Spagna, 28223
        • Reclutamento
        • NEXT Oncology Phase I Unit - Hospital Universitario Quironsalud Madrid (Investigational Site number ESP-008)
      • Reus, Spagna, 43204
        • Reclutamento
        • Hospital Universitari Sant Joan de Reus (Investigational Site number ESP-004)
      • Sabadell, Spagna, 08208
        • Reclutamento
        • Consorci Corporació Sanitària Parc Taulí - Hospital de Sabadell (Investigational Site number ESP-006)
      • Santiago de Compostela, Spagna, 15705
        • Reclutamento
        • Hospital Clinico Universitario Santiago de Compostela (Investigational Site number ESP-007)
  • Stati Uniti
    • California
      • Beverly Hills, California, Stati Uniti, 90212
        • Reclutamento
        • Precision NextGen Oncology and Research Center (Investigational Site number USA-001)
    • Florida
      • Margate, Florida, Stati Uniti, 33063
        • Reclutamento
        • D&H National Research Centers INC (Investigational Site number USA-002)
      • Port Orange, Florida, Stati Uniti, 32127
        • Reclutamento
        • United Medical Research (Investigational Site number USA-005)

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 80 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Femmina

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Femara® orale di origine statunitense
Droga: 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)
Sperimentale: Femara® orale di origine UE
Droga: 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)

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Area under the concentration-time curve within a dosing interval at Steady-State (SS AUCtau)
Lasso di tempo: 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

Individual and mean area under the concentration-time curve within a dosing interval at steady-state
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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Adverse Events
Lasso di tempo: From the time of obtaining signed informed consent until the final follow-up visit on Day 281 (or Day 421 for the subset of participants in the Extension Period)

Incidence of adverse events (type, severity, seriousness, and relationship to study drug), including the incidence of treatment-emergent adverse events (TEAEs), the incidence of serious TEAEs, and the incidence of TEAEs leading to treatment discontinuation.
From the time of obtaining signed informed consent until the final follow-up visit on Day 281 (or Day 421 for the subset of participants in the Extension Period)
Injection site reactions
Lasso di tempo: At pre-dose and 1 hour after each Letrozole SIE administration in TP2

Incidence of injection site reactions
At pre-dose and 1 hour after each Letrozole SIE administration in TP2
Injection-related pain score
Lasso di tempo: From baseline TP2 to the follow-up visit on Day 281

Changes in injection-related pain score by numeric rating scale (NRS). The NRS evaluates the intensity of injection-related pain experienced at the time of Letrozole SIE administration. It is scored from 0 to 10 (0 meaning no pain and 10 meaning the worst possible pain).
From baseline TP2 to the follow-up visit on Day 281
Bone mineral density (BMD) by dual energy x-ray absorptiometry (DXA)
Lasso di tempo: From screening to Day 281 TP2

Changes in bone mineral density BMD by DXA
From screening to Day 281 TP2
Average plasma drug concentration during a dosing interval at Steady-State (SS Cave)
Lasso di tempo: After multiple doses of Letrozole SIE until Day 281 TP2 and after multiple doses of US-sourced oral Femara® or EU-sourced oral Femara® at Day 14 TP1

Individual and mean steady-state average plasma drug concentration during a dosing interval
After multiple doses of Letrozole SIE until Day 281 TP2 and after multiple doses of US-sourced oral Femara® or EU-sourced oral Femara® at Day 14 TP1
Minimum drug concentration at steady-state (Cmin ss)
Lasso di tempo: After multiple doses of Letrozole SIE until Day 281 TP2 and after multiple doses of US-sourced oral Femara® or EU-sourced oral Femara® at Day 14 TP1

Minimum drug concentration at steady-state
After multiple doses of Letrozole SIE until Day 281 TP2 and after multiple doses of US-sourced oral Femara® or EU-sourced oral Femara® at Day 14 TP1
Maximum plasma concentration at steady-state (Cmax ss)
Lasso di tempo: After multiple doses of Letrozole SIE at Day 281 TP2 and after multiple doses of US-sourced oral Femara® or EU-sourced oral Femara® at Day 14 TP1

Maximum plasma concentration at steady-state
After multiple doses of Letrozole SIE at Day 281 TP2 and after multiple doses of US-sourced oral Femara® or EU-sourced oral Femara® at Day 14 TP1
Letrozole blood level percent fluctuation
Lasso di tempo: After multiple doses of Letrozole SIE at Day 281 TP2 and after multiple doses of US-sourced oral Femara® or EU-sourced oral Femara® at Day 14 TP1

Individual and mean letrozole blood percent fluctuation
After multiple doses of Letrozole SIE at Day 281 TP2 and after multiple doses of US-sourced oral Femara® or EU-sourced oral Femara® at Day 14 TP1
Time to peak observed concentration (Tmax)
Lasso di tempo: After multiple doses of Letrozole SIE until Day 281 TP2 and after multiple doses of US-sourced oral Femara® or EU-sourced oral Femara® at Day 14 TP1

Time to peak observed concentration
After multiple doses of Letrozole SIE until Day 281 TP2 and after multiple doses of US-sourced oral Femara® or EU-sourced oral Femara® at Day 14 TP1
Steady-State (SS)
Lasso di tempo: After multiple doses of Letrozole SIE until Day 281 TP2 and after multiple doses of US-sourced oral Femara® or EU-sourced oral Femara® at Day 14 TP1

Characterization of the steady-state
After multiple doses of Letrozole SIE until Day 281 TP2 and after multiple doses of US-sourced oral Femara® or EU-sourced oral Femara® at Day 14 TP1
Terminal rate constant (λz)
Lasso di tempo: After multiple doses of Letrozole SIE in TP2 until Day 421 in the Extension Period

Individual and mean Terminal rate constant (λz) after multiple doses of Letrozole SIE in the subset of participants in the Extension Period
After multiple doses of Letrozole SIE in TP2 until Day 421 in the Extension Period
Terminal half-life (t1/2)
Lasso di tempo: After multiple doses of Letrozole SIE in TP2 until Day 421 in the Extension Period

Individual and mean Terminal half-life after multiple doses of Letrozole SIE in the subset of participants in the Extension Period
After multiple doses of Letrozole SIE in TP2 until Day 421 in the Extension Period
Area under the curve extrapolated to infinity (AUC∞)
Lasso di tempo: After multiple doses of Letrozole SIE in TP2 until Day 421 in the Extension Period

Individual and mean Area under the curve extrapolated to infinity after multiple doses of Letrozole SIE in the subset of participants in the Extension Period
After multiple doses of Letrozole SIE in TP2 until Day 421 in the Extension Period
Area under the curve that is extrapolated (AUCextrap)
Lasso di tempo: After multiple doses of Letrozole SIE in TP2 until Day 421 in the Extension Period

Percentage of area under the curve that is extrapolated after multiple doses of Letrozole SIE in the subset of participants in the Extension Period
After multiple doses of Letrozole SIE in TP2 until Day 421 in the Extension Period

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Hormone supression
Lasso di tempo: From screening to the final follow-up visit on Day 281 (or Day 421 for the subset of participants in the Extension Period)

Analysis of letrozole exposure and hormone suppression measuring the sex hormone estrone (E1), sulfate estrone (SE1), and estradiol (E2) plasma levels.
From screening to the final follow-up visit on Day 281 (or Day 421 for the subset of participants in the Extension Period)
CYP2A6 genotyping
Lasso di tempo: From screening to final follow-up visit Day 281 (or Day 421 for the subset of participants in the Extension Period)

Proportion of participants in each CYP2A6 metabolizer phenotype category (normal, intermediate, slow)
From screening to final follow-up visit Day 281 (or Day 421 for the subset of participants in the Extension Period)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Rovi Pharmaceuticals Laboratories

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

8 giugno 2026

Completamento primario (Stimato)

1 maggio 2028

Completamento dello studio (Stimato)

1 ottobre 2028

Date di iscrizione allo studio

Primo inviato

22 gennaio 2026

Primo inviato che soddisfa i criteri di controllo qualità

3 febbraio 2026

Primo Inserito (Effettivo)

10 febbraio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

9 ottobre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

8 ottobre 2026

Ultimo verificato

1 ottobre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • ROV-SIE-2025-01
  • 2025-523269-31-00 (Ctis)
  • 2025 (Sovvenzione/contratto NIH degli Stati Uniti)

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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