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2018 ASCO Annual Meeting!

Session: Breast Cancer—Local/Regional/Adjuvant

Type: Poster Session

Time: Saturday June 2, 8:00 AM to 11:30 AM

Location: Hall A

Duration of extended adjuvant therapy with neratinib in early-stage HER2+ breast cancer after trastuzumab-based therapy: Exploratory analyses from the phase III ExteNET trial.

Adjuvant Therapy

Breast Cancer—Local/Regional/Adjuvant

2018 ASCO Annual Meeting

Abstract No:

Poster Board Number:
Poster Session (Board #16)

J Clin Oncol 36, 2018 (suppl; abstr 524)

Author(s): Michael Gnant, Hiroji Iwata, Anna Elizabeth Bashford, Robert Separovic, Adolfo Murias, Elena Vicente, Julie Ann Means-Powell, Ingrid A. Mayer, Francis Mark Senecal, Rina Hui, Richard H. De Boer, Joanne Chiu, Anne Armstrong, Amparo Ruiz, Richard Bryce, Yining Ye, Arlene Chan; Comprehensive Cancer Centre, Medical University of Vienna, Vienna, Austria; Aichi Cancer Center Hospital, Nagoya, Japan; Auckland Hosp, Auckland, New Zealand; University Hospital for Tumors, Zagreb, Croatia; Hospital Universitario Insular de Gran Canaria, Las Palmas, Spain; Vanderbilt-Ingram Cancer Center, Nashville, TN; Northwest Medical Specialties PLLC, Tacoma, WA; Westmead Hospital and the University of Sydney, Sydney, Australia; Royal Melbourne Hospital, Melbourne, Australia; Queen Mary Hospital, Hong Kong, Hong Kong; Christie Hospital Manchester; University of Manchester, Manchester, United Kingdom; Fundación Instituto Valenciano de Oncología, Valencia, Spain; Puma Biotechnology Inc., Los Angeles, CA; Breast Cancer Research Centre - WA & Curtin University, Perth, Australia

Abstract Disclosures


Background: The optimal duration of adjuvant therapy with targeted agents remains a question of ongoing relevance in oncology. ExteNET, an international, randomized, placebo-controlled phase III trial, showed that neratinib given for 12 months after trastuzumab-based therapy significantly improved 2- (HR 0.67, p = 0.009) and 5-year (HR 0.73, p = 0.008) invasive disease-free survival (iDFS) in early-stage HER2+ breast cancer [Chan et al. Lancet Oncol 2016; Martin et al. Lancet Oncol 2017]. We examined the influence of duration of neratinib therapy on efficacy in the ExteNET study. Methods: Patients with early-stage HER2+ breast cancer were randomly assigned to oral neratinib 240 mg/day or placebo for 12 months (or until disease recurrence) after standard primary therapy and trastuzumab-based (neo)adjuvant therapy. Patients who received neratinib for ≤3 or ≥11 months (the median duration of neratinib treatment) were each compared with the ITT placebo group. iDFS (primary endpoint) was analyzed using Kaplan-Meier methods and Cox proportional-hazards models adjusted for prognostic factors. Data cut-off: March 1, 2017. NCT00878709. Results: ITT population comprised 2840 patients (neratinib, n = 1420; placebo, n = 1420). Median treatment duration (ITT population) was 11.6 and 11.8 months in the neratinib and placebo groups, respectively. 391 patients received neratinib for ≤3 months. 872 patients received neratinib for ≥11 months or stopped treatment prior to 11 months due to recurrence. Results after a median of 5.2 years' follow-up are shown below. Conclusions: These exploratory data suggest that patients who remained on neratinib for ≥11 months derived clear benefits from therapy, whereas neratinib efficacy was considerably reduced in those who stopped treatment early (≤3 months).Clinical trial information: NCT00878709

Duration of neratinibN5-year iDFS rate, %
HR (95% CI)
≤3 months181188.487.70.90 (0.59-1.32)
≥11 months2292a91.087.70.67 (0.50-0.88)
ITT284090.287.70.73 (0.57-0.92)b

a14 patients stopped treatment before 11 months due to recurrence.

bAdjusted for stratification factors.

Other Abstracts in this Sub-Category:


1. TAILORx: Phase III trial of chemoendocrine therapy versus endocrine therapy alone in hormone receptor-positive, HER2-negative, node-negative breast cancer and an intermediate prognosis 21-gene recurrence score.

Meeting: 2018 ASCO Annual Meeting Abstract No: LBA1 First Author: Joseph A. Sparano
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2. Adjuvant denosumab in early breast cancer: Disease-free survival analysis of 3,425 postmenopausal patients in the ABCSG-18 trial.

Meeting: 2018 ASCO Annual Meeting Abstract No: 500 First Author: Michael Gnant
Category: Breast Cancer—Local/Regional/Adjuvant - Adjuvant Therapy


3. Adjuvant denosumab in early breast cancer: First results from the international multicenter randomized phase III placebo controlled D-CARE study.

Meeting: 2018 ASCO Annual Meeting Abstract No: 501 First Author: Robert E. Coleman
Category: Breast Cancer—Local/Regional/Adjuvant - Adjuvant Therapy