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

20 de mayo de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

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 de estudio

Intervencionista

Inscripción (Estimado)

100

Fase

  • Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Jian Zhang
  • Número de teléfono: 85000 +8664175590
  • Correo electrónico: syner2000@163.com

Copia de seguridad de contactos de estudio

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto

Acepta Voluntarios Saludables

No

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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)
Comparador activo: 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)

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Proportion of Participants with E2 <30 pg/mL at 3 Months
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Proportion of patients with E2 <30 pg/mL at 6 months after randomization
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Fudan University

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de junio de 2026

Finalización primaria (Estimado)

1 de septiembre de 2027

Finalización del estudio (Estimado)

1 de junio de 2030

Fechas de registro del estudio

Enviado por primera vez

14 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

20 de mayo de 2026

Publicado por primera vez (Actual)

28 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

28 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

20 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • IFOCOS

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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