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Impact of Formulation Change on Ovarian Suppression in Young Breast Cancer Patients. (IFOCOS)

20 maggio 2026 aggiornato da: Jian Zhang,MD, Fudan University

A Multicenter, Prospective, Randomized Controlled Study-Impact of Formulation Change on Ovarian Suppression in Young Breast Cancer Patients (IFOCOS)

This is a multicenter, prospective, randomized controlled, phase II study. The primary objective is to evaluate the effect of endocrine therapy modification (switching from a 3-month to a 1-month GnRHa) versus continuation of the 3-month GnRHa on E2 control at 3 months in young patients with hormone receptor-positive breast cancer and iOFS.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

In China, breast cancer occurs at a young age, with a peak incidence at 40-49 years; patients aged ≤45 years account for 20%-24% of cases, and this proportion is increasing. Ovarian function suppression (OFS) combined with aromatase inhibitor (AI) or tamoxifen (TAM), with or without CDK4/6 inhibitors, has become a preferred adjuvant endocrine therapy for intermediate to high-risk premenopausal hormone receptor-positive (HR+) patients with HR+ breast cancer. AI is effective in premenopausal women only when ovarian estrogen production is suppressed, which can be achieved with GnRH agonists (GnRHa). The 3-month GnRHa formulation is commonly preferred in the real world due to its convenience and reduced injection frequency; however, its effectiveness compared with the 1-month formulation remains a concern.

Among premenopausal patients receiving GnRHa combined with AI or TAM, approximately 8% experience incomplete ovarian function suppression (iOFS, E2 ≥30 pg/mL). Persistent iOFS may reduce the efficacy of endocrine therapy and potentially increase the risk of disease recurrence. Current clinical guidelines recommend monitoring serum estradiol (E2) levels during GnRHa treatment and suggest potential management strategies, including switching GnRHa formulations from 3-month to 1-month or modifying endocrine therapy (e.g., AI to TAM). However, evidence supporting these strategies is largely derived from retrospective studies or small case series, and prospective data remain limited. This multicenter, prospective, randomized, phase II study is designed to evaluate whether switching from a 3-month to a 1-month GnRHa can reduce E2 levels to <30 pg/mL within 3 months in premenopausal HR+ young breast cancer patients with iOFS. This study will also assess the long-term efficacy and safety of this strategy.

Tipo di studio

Interventistico

Iscrizione (Stimato)

100

Fase

  • Fase 2

Contatti e Sedi

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

Contatto studio

Backup dei contatti dello studio

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

  • Adulto

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

Step 1：iOFS detection phase

  1. Female, aged ≥18 and ≤45 years;
  2. Histologically confirmed hormone receptor-positive (HR+) (estrogen receptor [ER] and/or progesterone receptor [PR] ≥1%) and human epidermal growth factor receptor 2-negative (HER2-) early invasive breast cancer (stage I-III according to the American Joint Committee on Cancer [AJCC], version 8)；
  3. Completed curative surgery, with prior (neo)adjuvant chemotherapy and radiotherapy completed if applicable;
  4. Currently receiving adjuvant therapy with a 3-month GnRH agonist (GnRHa) plus aromatase inhibitor (AI) or tamoxifen (TAM), with or without CDK4/6 inhibitors (excluding abemaciclib due to its potential interference with estradiol monitoring), for ≥1 dose, and presenting with estradiol (E2) ≥30 pg/mL within 28 days prior to enrollment (measured by CLIA).
  5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1; adequate bone marrow, hepatic, renal, and cardiac function.
  6. Voluntarily sign a written informed consent form before the trial screening.

Step 2：Randomized treatment phase

  1. iOFS confirmed using the SEMS assay (E2 ≥30 pg/mL);
  2. Ongoing adjuvant therapy with a 3-month GnRHa plus AI or TAM, with or without CDK4/6 inhibitors.
  3. No evidence of disease progression.

Exclusion Criteria:

Step 1：iOFS detection phase

  1. Bilateral breast cancer, inflammatory breast cancer, or distant metastasis;
  2. Use of GnRHa for ovarian function preservation;
  3. History of ovarian resection or ablation; planned pregnancy or breastfeeding;
  4. Concomitant use of hormonal agents other than estrogen, progesterone, selective estrogen receptor modulators (SERM), or selective estrogen receptor degraders (SERD);
  5. Severe uncontrolled comorbidities;
  6. Other malignancies within the past 5 years (except for curatively treated carcinoma in situ of the cervix or basal cell carcinoma);
  7. Failure to comply with follow-up or psychiatric disorders.

Step 2：Randomized treatment phase

a)Prior conversion from a 3-month GnRHa to a 1-month GnRHa.

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: Experimental: 1-month GnRH + endocrine therapy
1-month GnRH (goserelin 3.6 mg depot or goserelin 3.6 mg implant or leuprolide 3.75 mg depot) +endocrine therapy (aromatase inhibitor/tamoxifen±CDK4/6 inhibition)
Droga: 1-month GnRH
1-month GnRH (goserelin 3.6 mg depot or goserelin 3.6 mg implant or leuprolide 3.75 mg depot) +endocrine therapy (aromatase inhibitor/tamoxifen±CDK4/6 inhibition)
Comparatore attivo: Active Comparator: Control
3-month GnRH (goserelin 10.8 mg implant or leuprolide 11.25 mg depot) + endocrine therapy (aromatase inhibitor/tamoxifen±CDK4/6 inhibition)
Droga: 3-month GnRH
3-month GnRH (goserelin 10.8 mg implant or leuprolide 11.25 mg depot) + endocrine therapy (aromatase inhibitor/tamoxifen±CDK4/6 inhibition)

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Proportion of Participants with E2 <30 pg/mL at 3 Months
Lasso di tempo: 3 months post randomization
The primary endpoint is defined as the proportion of patients with E2 <30 pg/mL at 3 months, comparing patients who switch to GnRHa 1M versus those who continue GnRHa 3M therapy.
3 months post randomization

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Proportion of patients with E2 <30 pg/mL at 6 months after randomization
Lasso di tempo: 6 months post randomization
This endpoint is defined as the proportion of patients with E2 <30 pg/mL at 6 months, comparing patients who switch to GnRHa 1M versus those who continue GnRHa 3M therapy.
6 months post randomization
Time to adequate ovarian function suppression
Lasso di tempo: Assessed over a period of up to 12 months following randomization
This endpoint is defined as the time from the first occurrence of iOFS to the first measurement of E2 <30 pg/mL.
Assessed over a period of up to 12 months following randomization
Patient Age
Lasso di tempo: At randomization
Age of participants at the time of randomization, categorized by iOFS status (Persistent vs. Transient).
At randomization
3-year invasive disease-free survival in patients who switch to GnRHa 1M versus those who continue GnRHa 3M therapy
Lasso di tempo: From the date of randomization until the date of locoregional recurrence, distant metastasis, second primary breast cancer, or death from any cause, up to 3 months
Invasive disease-free survival is defined as the time from randomization to the first occurrence of locoregional recurrence, distant metastasis, second primary breast cancer, or death from any cause.
From the date of randomization until the date of locoregional recurrence, distant metastasis, second primary breast cancer, or death from any cause, up to 3 months
3-year invasive disease-free survival in patients with persistent iOFS and those with transient iOFS
Lasso di tempo: From the date of randomization until the date of locoregional recurrence, distant metastasis, second primary breast cancer, or death from any cause, up to 3 months
From the date of randomization until the date of locoregional recurrence, distant metastasis, second primary breast cancer, or death from any cause, up to 3 months
Intraclass Correlation Coefficient (ICC) for the Consistency of the SEMS Method
Lasso di tempo: post SEMS assay
The consistency of the SEMS method will be assessed by calculating the Intraclass Correlation Coefficient (ICC) between GnRHa 1M and GnRHa 1M at the post-assay time point.
post SEMS assay
Adverse events
Lasso di tempo: From the date of treatment initiation until the date of disease progression, intolerable toxicities, death, withdrawal of consent, or completion of planned 3-year postoperative follow-up, whichever occurred first
Adverse events will be graded according to the NCI-CTCAE Version 5.0.
From the date of treatment initiation until the date of disease progression, intolerable toxicities, death, withdrawal of consent, or completion of planned 3-year postoperative follow-up, whichever occurred first

Collaboratori e investigatori

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

Sponsor

Fudan University

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 (Stimato)

1 giugno 2026

Completamento primario (Stimato)

1 settembre 2027

Completamento dello studio (Stimato)

1 giugno 2030

Date di iscrizione allo studio

Primo inviato

14 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

20 maggio 2026

Primo Inserito (Effettivo)

28 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

28 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

20 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • IFOCOS

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

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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Malattie rare

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