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Association of cancer antigen 15-3 with distant recurrence in immunohistochemically defined breast cancer subtypes in Canadian Cancer Trials Group MA.32.

Pamela J Goodwin·Bingshu E Chen·Karen A Gelmon·Timothy J Whelan·Marguerite Ennis·Jennifer Ligibel·Paul M Stos·Lois E Shepherd·Wendy R Parulekar·Vuk Stambolic
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Abstract

BACKGROUND: Circulating levels of cancer antigen (CA) 15-3 have been associated with distant breast cancer recurrence; data on breast cancer subtypes are sparse. We examined associations of CA 15-3 with outcomes across immunohistochemically defined breast cancer subtypes in MA.32. METHODS: A total of 3649 participants with T1-3, N0-1, M0 breast cancer were randomly assigned; 2740 (75.1%) provided blood at entry (mean = 278&#x2009;days postdiagnosis) and 6&#x2009;months later. Prognostic associations of baseline and 6-month change in CA 15-3 with distant recurrence-free survival (RFS) were examined in luminal (estrogen receptor-positive and/or progesterone receptor-positive, HER2-negative), triple-negative (estrogen receptor, progesterone receptor, HER2 negative) and HER2-positive (any estrogen receptor, progesterone receptor) breast cancer using Cox proportional hazards models. RESULTS: Mean age was 52&#x2009;years. Breast cancer was luminal in 1589 (58.7%), triple negative in 655 (24.2%), and HER2 positive in 464 (17.1%) participants. Median follow-up was 96&#x2009;months. CA 15-3 at study entry was not associated with outcome in any subtype. Rising CA 15-3 at 6&#x2009;months was associated with poor distant RFS in luminal and triple-negative breast cancer (hazard ratio [HR] per 25% increase&#x2009;=&#x2009;1.41, P&#x2009;<&#x2009;.0001, and HR = 1.35, P&#x2009;<&#x2009;.0001, respectively). New elevations in CA 15-3 at 6&#x2009;months were adversely associated with distant RFS in those with luminal or triple-negative breast cancer (HR = 4.14, 95% CI = 2.69 to 6.38; P&#x2009;<&#x2009;.001; and HR = 3.57, 95% CI = 1.59 to 7.99; P&#x2009;=&#x2009;.002, respectively). In HER2-positive breast cancer, CA15-3 was not associated with distant RFS. CONCLUSION: Rising CA 15-3 was associated with reduced distant RFS in luminal and triple-negative breast cancer but not in HER2-positive breast cancer. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov NCT01101438.

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HumansFemaleMiddle AgedMucin-1Erb-b2 Receptor Tyrosine KinasesReceptors, ProgesteroneTriple Negative Breast NeoplasmsBreast NeoplasmsReceptors, EstrogenProportional Hazards ModelsAdultNeoplasm Recurrence, LocalDisease-Free SurvivalBiomarkers, TumorAgedImmunohistochemistryCanadaPrognosisJournal ArticleRandomized Controlled Trial

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Pamela J Goodwin, Bingshu E Chen, Karen A Gelmon, Timothy J Whelan, Marguerite Ennis, Jennifer Ligibel, Paul M Stos, Lois E Shepherd, Wendy R Parulekar, Vuk Stambolic. 2026-09-03. Association of cancer antigen 15-3 with distant recurrence in immunohistochemically defined breast cancer subtypes in Canadian Cancer Trials Group MA.32.. https://doi.org/10.1093/jncics%2Fpkag068

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Journal Article; Randomized Controlled Trial resourceAdult subjectAged subjectBiomarkers, Tumor subjectBreast Neoplasms subjectErb-b2 Receptor Tyrosine Kinases subjectFemale subjectHumans subjectImmunohistochemistry subjectJournal Article subjectMiddle Aged subjectPrognosis subjectProportional Hazards Models subjectRandomized controlled trials study

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