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

Conditions

• HER2-Positive Breast Carcinoma
• Invasive Breast Carcinoma
• Metastatic Malignant Neoplasm in the Brain
• Recurrent Breast Carcinoma
• Stage IV Breast Cancer AJCC v6 and v7

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Laboratory Biomarker Analysis — OTHER
  Correlative studies
• Lapatinib Ditosylate — DRUG
  Given PO
• Stereotactic Radiosurgery — RADIATION
  Undergo SRS
• Whole-Brain Radiotherapy — RADIATION
  Undergo WBRT

Study Details

This randomized phase II trial studies how well whole-brain radiation therapy or stereotactic radiosurgery with or without lapatinib ditosylate works in treating patients with breast cancer that has too many of a protein called human epidermal growth factor receptor 2 (HER2) on its cells and has spread to the brain. Radiation therapy uses high energy x rays to kill tumor cells and shrink tumors. Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may kill more tumor cells and cause less damage to normal tissue. Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether whole-brain radiation therapy or stereotactic radiosurgery together with lapatinib ditosylate is an effective treatment for brain metastasis from breast cancer.

Key Dates

Start date

Dec 6, 2012

Status verified

Sep 2023

Primary completion

Dec 30, 2019

Completion

May 20, 2022

Study Design

Enrollment

143 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A (WBRT or SRS)
  Patients undergo WBRT 5 days a week for 3 weeks for a total of 15 treatments, or SRS for 1 treatment.
• Experimental: Arm B (lapatinib ditosylate, WBRT or SRS)
  Patients undergo WBRT or SRS as in Arm A. Patients also receive lapatinib ditosylate PO QD for 6 weeks.

Primary Outcome Measure

Complete Response (CR) Rate in the Brain at 12 Weeks Post-radiation Therapy (RT) Using the RECIST 1.1 Criteria Based on Brain Magnetic Resonance Imaging (MRI) [ Time Frame: Baseline and 12 weeks post RT (approximately 12 weeks from start of treatment if SRS and 15 if WBRT) ]

Locations (292)

Find similar trials in Birmingham, AL

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