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Observational Study
. 2025 Jul 30;27(6):1550-1558.
doi: 10.1093/neuonc/noaf018.

Phase II trial of brain MRI surveillance in stage IV breast cancer

Kamran A Ahmed  1 , Youngchul Kim  2 , Avan J Armaghani  3 , John A Arrington  4 , Ricardo L Costa  3 , Brian J Czerniecki  3 , Roberto Diaz  1 , Robin A Dowell  1 , Martine Extermann  5 , Peter A Forsyth  6 , Kimberley T Lee  3 , Loretta Loftus  3 , Matthew N Mills  1 , Vania H Phuoc  3 , Marilin Rosa  3 , Hatem H Soliman  3 , Christine S Sam  5 , Iman R Washington  1 , Aixa E Soyano  3 , Hyo S Han  3
Affiliations
Observational Study

Phase II trial of brain MRI surveillance in stage IV breast cancer

Kamran A Ahmed et al. Neuro Oncol. .

Abstract

Background: Screening of asymptomatic stage IV breast cancer with brain MRIs is currently not recommended by National Comprehensive Cancer Network Guidelines. The incidence of asymptomatic brain metastasis is not well documented.

Methods: The study is designed as a single-arm, phase II trial, with the goal of investigating surveillance brain MRIs in neurologically asymptomatic patients with metastatic breast cancer. Breast cancer patients were classified into triple-negative (TN), HER2+, and hormone receptor (HR)+/HER2-. Patients underwent a surveillance brain MRI and a second brain MRI at 6 months if the baseline MRI was negative. Asymptomatic, stage IV breast cancer patients, ECOG ≤ 2, and life expectancy ≥ 6 months were eligible. The primary objective was to determine the frequency of asymptomatic brain metastasis in metastatic breast cancer. Clinical trial information: NCT05115474.

Results: A total of 101 patients completed the surveillance brain MRI including 40 HR+/HER2-, 33 HER2+, and 28 TN patients. The overall frequency of brain metastasis on initial surveillance brain MRI was 14% (n = 14) with rates of 18%, 15%, and 10% in TN, HER2+, and HR+/HER2- patients, respectively. Following the 6-month MRI, the cumulative rates of brain metastasis increased to 25% in TN, 24% in HER2+, and 23% in HR+/HER2- patients.

Conclusions: The highest frequency of brain metastases at baseline was in TN and HER2+ breast cancer. Following the 6-month MRI, the cumulative frequency was approximately a quarter across all subtypes. These results warrant confirmatory trials to refine brain MRI surveillance recommendations for neurologically asymptomatic stage IV breast cancer.

Keywords: brain MRI; brain metastases; stage IV breast cancer; surveillance.

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Conflict of interest statement

P.A.F. has received research funding from Pfizer and Celgene and is on the advisory boards of Novocure, BTG, Inovio, AbbVie, Ziopharm, Tocagen, and Pfizer. H.S. serves as a consultant for Astrazeneca, Celgene, Novartis, PUMA, and Eisai, is on advisory boards for Novartis, Eisai, PUMA, Eli Lilly, Astrazeneca, and received speaker fees from Merck. H.S.H. declares research funding from Abbvie, Arvinas, Celcuity, Ellipses, Pfizer, Mersana, Quantum Leap Healthcare Collaborative, Zymeworks, and is on advisory boards for Pfizer and Arvinas. K.A.A. has received research funding from Bristol-Myers Squibb, Eli Lilly, and Genentech. M.E. has received honoraria from OncLive. R.C. has received honorariums from Gilead, Pfizer, Athenex, Immunomedics, Daiichi Sankyo, and Astrazeneca. M.R. is a consultant for Astrazeneca. Roberto Diaz is a consultant for Lumicell.

Figures

Figure 1.
Figure 1.
CONSORT Diagram.
Figure 2.
Figure 2.
Frequency of brain metastases by subtype at time of first MRI, second MRI, and cumulative.
Figure 3.
Figure 3.
Kaplan–Meier overall survival following brain metastasis diagnosis by subtype.
See this image and copyright information in PMC

References

    1. Tabouret E, Chinot O, Metellus P, et al. Recent trends in epidemiology of brain metastases: an overview. Anticancer Res. 2012;32(11):4655–4662. - PubMed
    1. Waks AG, Winer EP.. Breast cancer treatment: a review. JAMA. 2019;321(3):288–300. - PubMed
    1. Miglietta F, Bottosso M, Griguolo G, Dieci MV, Guarneri V.. Major advancements in metastatic breast cancer treatment: when expanding options means prolonging survival. ESMO Open. 2022;7(2):100409. - PMC - PubMed
    1. Lin NU, Borges V, Anders C, et al. Intracranial efficacy and survival with Tucatinib plus Trastuzumab and Capecitabine for previously treated HER2-positive breast cancer with brain metastases in the HER2CLIMB trial. J Clin Oncol. 2020;38(23):2610–2619. - PMC - PubMed
    1. Tolaney SM, Sahebjam S, Le Rhun E, et al. A phase II study of Abemaciclib in patients with brain metastases secondary to hormone receptor-positive breast cancer. Clin Cancer Res. 2020;26(20):5310–5319. - PubMed

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