Whole-Brain Radiation Therapy or Stereotactic Radiosurgery With or Without Lapatinib Ditosylate in Treating Patients With Brain Metastasis From HER2-Positive Breast Cancer

Titre officiel

Phase II Randomized Study of Whole Brain Radiation Therapy/Stereotactic Radiosurgery in Combination With Concurrent Lapatinib in Patients With Brain Metastasis From HER2-Positive Breast Cancer: A Collaborative Study of NRG Oncology and KROG

Sommaire:

Cet essai de phase II randomisé étudie l'efficacité d'une radiothérapie du cerveau avec ou sans lapatinib ditosylate pour le traitement des patients atteints de métastases au cerveau du cancer du sein à récepteur du facteur de croissance épidermique humain 2 (HER2) positif. La radiothérapie utilise des rayons X à forte énergie pour tuer les cellules tumorales. Le lapatinib ditosylate pourrait arrêter la croissance des cellules tumorales en bloquant quelques-unes des enzymes qui sont nécessaires à la croissance cellulaire. On ne sait pas encore si la radiothérapie associée au lapatinib ditosylate est un traitement efficace pour les métastases au cerveau du cancer du sein.

Description de l'essai

Primary Outcome:

  • Complete response (CR) rate in the measurable brain metastases measured by Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 based on magnetic resonance imaging (MRI) scan of the brain
Secondary Outcome:
  • CR rate of measurable brain metastases measured using revised RECIST version 1.1 based on MRI scan of the brain
  • Objective response rate (ORR) (CR + partial response [PR]) of measurable brain metastases measured using RECIST version 1.1 based on MRI scan of the brain
  • ORR (CR + PR) of measurable brain metastases measured using RECIST version 1.1 based on MRI scan of the brain
  • Central nervous system (CNS) progressive disease outside the targeted measurable disease
  • Targeted lesion-specific progression
  • Targeted lesion-specific progression
  • Incidence of treatment-related toxicity as measured by Common Terminology Criteria for Adverse Events version 4
  • Overall CNS complete response
  • Overall CNS progressive disease
  • Overall survival (OS)
PRIMARY OBJECTIVES:
I. To determine if there is a signal for an increase in complete response (CR) rate in the measurable brain metastases at 12 weeks post radiation therapy (RT) (whole brain or stereotactic radiosurgery [SRS]) as determined by magnetic-resonance imaging (MRI) scan of the brain, with the addition of lapatinib (lapatinib ditosylate) to whole-brain radiation therapy (WBRT)/SRS compared to WBRT/SRS alone. SECONDARY OBJECTIVES:
I. To evaluate CR rate of the measurable brain metastases at 4 weeks post RT (WBRT/SRS) as determined by MRI scan of the brain, with the addition of lapatinib to WBRT/SRS compared to WBRT/SRS alone. II. To evaluate objective response rate of measurable brain metastases at 4 and 12 weeks post RT (WBRT/SRS) as determined by MRI scan of the brain, with the addition of lapatinib to WBRT/SRS compared to WBRT/SRS alone. III. To evaluate targeted lesion-specific objective response rate (CR + partial response [PR]) at 4 and 12 weeks post WBRT/SRS. IV. To evaluate central nervous system (CNS) progressive disease outside the targeted measurable disease with addition of lapatinib to WBRT/SRS compared to WBRT/SRS alone. V. To evaluate targeted lesion-specific progression at 4 and 12 weeks post WBRT/SRS. VI. To evaluate treatment related adverse events when adding lapatinib to WBRT/SRS compared to WBRT/SRS alone. VII. To evaluate overall CNS complete response: disappearance of all CNS target lesions sustained for at least 4 weeks; with no new lesions, no use of corticosteroids, and patient is stable or improved clinically, when adding lapatinib to WBRT/SRS compared to WBRT/SRS alone. VIII. To evaluate overall CNS progressive disease (within or outside targeted measurable disease) with addition of lapatinib to WBRT/SRS compared to WBRT/SRS alone. IX. To evaluate overall survival when adding lapatinib to WBRT/SRS compared to WBRT/SRS alone. OUTLINE:

Patients are randomized to 1 of 2 treatment arms. ARM A: Patients undergo WBRT 5 days a week for 3 weeks for a total of 15 treatments or SRS for 1 treatment. ARM B: Patients undergo WBRT or SRS as in Arm A. Patients also receive lapatinib ditosylate orally (PO) once daily (QD) for 6 weeks. After completion of study treatment, patients are followed up at 4 and 12 weeks and then every 12 weeks thereafter.

Voir cet essai sur ClinicalTrials.gov

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