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

Summary

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.

Timeline

Start

2012-12-06

Primary completion

2019-12-30

Completion

2022-05-20

Outcome

Missed primary endpoint

paper RT + lapatinib did not improve 12-week CR (0% vs 6% for RT alone, 1-sided P = .97) PMID 37506981 ↗

Publications

• Kim IA, Winter KA, Sperduto PW, De Los Santos JF, Peereboom DM, Ogunleye T, Boulter D, Fritz JM, Cho KH, Shin KH, Zoberi I, Choi S, Palmer JD, Liem B, Kim YB, Anderson BM, Thakrar AW, Muanza TM, Kim MM, Choi DH, Mehta MP, White JR. Concurrent Lapatinib With Brain Radiation Therapy in Patients With HER2+ Breast Cancer With Brain Metastases: NRG Oncology-KROG/RTOG 1119 Phase 2 Randomized Trial. Int J Radiat Oncol Biol Phys. 2024 Apr 1;118(5):1391-1401. doi: 10.1016/j.ijrobp.2023.07.019. Epub 2023 Jul 26.

Drugs

Indications