Cited by 193HER2/EGFR in Cancer ResearchLung Cancer Treatments and MutationsCancer Genomics and Diagnostics

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Neratinib Efficacy and Circulating Tumor DNA Detection of HER2 Mutations in HER2 Nonamplified Metastatic Breast Cancer

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Ma, Cynthia X., Bose, Ron, Gao, Feng, Freedman, Rachel A., Telli, Melinda L., Kimmick, Gretchen, Winer, Eric, Naughton, Michael, Goetz, Matthew P., Russell, Christy, Tripathy, Debu, Cobleigh, Melody, Forero, Andres, Pluard, Timothy J., Anders, Carey, Niravath, Polly Ann, Thomas, Shana, Anderson, Jill, Bumb, Caroline, Banks, Kimberly C., Lanman, Richard B., Bryce, Richard, Lalani, Alshad S., Pfeifer, John, Hayes, Daniel F., Pegram, Mark, Blackwell, Kimberly, Bedard, Philippe L., Al-Kateb, Hussam, Ellis, Matthew J.C.·2017·Clinical Cancer Research

DOI 10.1158/1078-0432.ccr-17-0900PMC PMC6746403

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Abstract

Purpose: Based on promising preclinical data, we conducted a single-arm phase II trial to assess the clinical benefit rate (CBR) of neratinib, defined as complete/partial response (CR/PR) or stable disease (SD) ≥24 weeks, in HER2mut nonamplified metastatic breast cancer (MBC). Secondary endpoints included progression-free survival (PFS), toxicity, and circulating tumor DNA (ctDNA) HER2mut detection. Experimental Design: Tumor tissue positive for HER2mut was required for eligibility. Neratinib was administered 240 mg daily with prophylactic loperamide. ctDNA sequencing was performed retrospectively for 54 patients (14 positive and 40 negative for tumor HER2mut). Results: Nine of 381 tumors (2.4%) sequenced centrally harbored HER2mut (lobular 7.8% vs. ductal 1.6%; P = 0.026). Thirteen additional HER2mut cases were identified locally. Twenty-one of these 22 HER2mut cases were estrogen receptor positive. Sixteen patients [median age 58 (31–74) years and three (2–10) prior metastatic regimens] received neratinib. The CBR was 31% [90% confidence interval (CI), 13%–55%], including one CR, one PR, and three SD ≥24 weeks. Median PFS was 16 (90% CI, 8–31) weeks. Diarrhea (grade 2, 44%; grade 3, 25%) was the most common adverse event. Baseline ctDNA sequencing identified the same HER2mut in 11 of 14 tumor-positive cases (sensitivity, 79%; 90% CI, 53%–94%) and correctly assigned 32 of 32 informative negative cases (specificity, 100%; 90% CI, 91%–100%). In addition, ctDNA HER2mut variant allele frequency decreased in nine of 11 paired samples at week 4, followed by an increase upon progression. Conclusions: Neratinib is active in HER2mut, nonamplified MBC. ctDNA sequencing offers a noninvasive strategy to identify patients with HER2mut cancers for clinical trial participation. Clin Cancer Res; 23(19); 5687–95. ©2017 AACR.

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Authors: Ma, C. X., Bose, R., Gao, F., Freedman, R. A., Telli, M. L., Kimmick, G., Winer, E., Naughton, M., Goetz, M. P., Russell, C., Tripathy, D., Cobleigh, M., Forero, A., Pluard, T. J., Anders, C., Niravath, P. A., Thomas, S., Anderson, J., Bumb, C., Banks, K. C., Lanman, R. B., Bryce, R., Lalani, A. S., Pfeifer, J., Hayes, D. F., Pegram, M., Blackwell, K., Bedard, P. L., Al-Kateb, H., & Ellis, M. J. C.
Affiliations: Washington University in St. Louis (US)
Dana-Farber Cancer Institute (US)
Stanford Medicine (US)
Duke University (US)
Mayo Clinic (US)
University of Southern California (US)
Rush University Medical Center (US)
University of Alabama at Birmingham (US)
Saint Luke's Hospital (US)
University of North Carolina at Chapel Hill (US)
Baylor College of Medicine (US)
Guardant (United States) (US)
Puma Biotechnology (United States) (US)
University of Michigan (US)
Princess Margaret Cancer Centre (CA)
15Genomic and Pathology Service, Washington University School of Medicine, St. Louis, Missouri.
ORCID: Ma, Cynthia X.
Bose, Ron
Gao, Feng
Freedman, Rachel A.
Telli, Melinda L.
Kimmick, Gretchen
Winer, Eric
Goetz, Matthew P.
Russell, Christy
Tripathy, Debu
Cobleigh, Melody
Forero, Andres
Pluard, Timothy J.
Anders, Carey
Niravath, Polly Ann
Thomas, Shana
Banks, Kimberly C.
Lanman, Richard B.
Bryce, Richard
Lalani, Alshad S.
Pfeifer, John
Hayes, Daniel F.
Pegram, Mark
Blackwell, Kimberly
Bedard, Philippe L.
Ellis, Matthew J.C.
Venue: Clinical Cancer Research
Publisher: American Association for Cancer Research (AACR)
Published: 2017-10-01
Volume: 23
Issue: 19
Pages: 5687-5695
ISSN: 1078-0432 (ISSN-L)
1557-3265
DOI: 10.1158/1078-0432.ccr-17-0900
PMC: PMC6746403
OpenAlex: W2726739357
Cited by: 193
References: 49
Citations by year: 2026: 6 · 2025: 10 · 2024: 6 · 2023: 29 · 2022: 28 · 2021: 33 · 2020: 29 · 2019: 28 · 2018: 20 · 2017: 3
FWCI: 9.64
Type: journal article
Language: en
Open access: green
www.ncbi.nlm.nih.gov
Locations: Clinical Cancer Research (publishedVersion)
PubMed (publishedVersion)
PubMed Central (acceptedVersion)
Funders: Puma Biotechnology
National Cancer Institute (P30CA091842, P30CA016086)
Topics: Health Sciences › Medicine › Oncology › HER2/EGFR in Cancer Research
Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Cancer Genomics and Diagnostics
Keywords: neratinib, HER2 mutation, circulating tumor DNA, liquid biopsy, clinical benefit rate, progression-free survival, diarrhea, HER2-positive breast cancer, lobular breast cancer, estrogen receptor-positive breast cancer, patient selection for clinical trials, targeted therapy
MeSH terms: Circulating Tumor DNA, Adult, Aged, Breast Neoplasms, Female, Humans, Middle Aged, Mutation, Neoplasm Metastasis, Quinolines, Treatment Outcome, Disease-Free Survival, Erb-b2 Receptor Tyrosine Kinases

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Neratinib Efficacy and Circulating Tumor DNA Detection of HER2 Mutations in HER2 Nonamplified Metastatic Breast Cancer

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