{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,20]],"date-time":"2026-10-20T15:28:51Z","timestamp":1792510131445,"version":"4.5.0"},"reference-count":48,"publisher":"Harborside Press, LLC","issue":"12","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2025,12]]},"abstract":"\n Background:<\/jats:bold>\n Data on the effectiveness of ovarian function suppression (OFS) in premenopausal patients with hormone receptor (HR)\u2013positive, HER2-positive breast cancer are sparse. We investigated the prognostic impact of incorporating OFS in premenopausal women with HER-positive, HR-positive breast cancer, drawing on data from the HERceptin Adjuvant (HERA) trial.\n Patients and Methods:<\/jats:bold>\n We examined patient-level data from the HERA trial (BIG1-01) to assess whether adding OFS enhances disease-free survival (DFS) and overall survival (OS) in premenopausal women with early-stage HR-positive, HER2-positive breast cancer. Additionally, we explored differences in prognosis between types of oral antiestrogens, specifically tamoxifen (TAM) and aromatase inhibitors (AIs).\n Results:<\/jats:bold>\n A total of 965 patients were included in our analysis; 501 (51.9%) received TAM only, and 464 (48.1%) underwent endocrine therapy with OFS. The addition of OFS independently correlated with enhanced DFS (hazard ratio, 0.68; 95% CI, 0.53\u20130.87;\n P<\/jats:italic>\n =.002) and OS (hazard ratio, 0.62; 95% CI, 0.44\u20130.85;\n P<\/jats:italic>\n =.003). The 10-year DFS rates were 70.9% with OFS versus 59.6% with TAM only, whereas the 10-year OS rates were 84.7% with OFS versus 74.0% with TAM only. Among the patients treated with OFS, AI was associated with favorable survival outcomes compared with TAM.\n Conclusions:<\/jats:bold>\n Our findings suggest that adding OFS to adjuvant endocrine therapy may improve survival outcomes in premenopausal women with HR-positive, HER2-positive breast cancer who are receiving chemotherapy and HER2-targeted therapy, and are at high risk of relapse.\n <\/jats:p>\n \n ClinicalTrials.gov identifier:<\/jats:bold>\n NCT00045032<\/jats:ext-link>\n <\/jats:p>","DOI":"10.6004\/jnccn.2025.7080","type":"journal-article","created":{"date-parts":[[2025,12,17]],"date-time":"2025-12-17T13:56:16Z","timestamp":1765979776000},"page":"539-547","source":"Crossref","is-referenced-by-count":8,"title":["Ovarian Function Suppression in HR-Positive, HER2-Positive Breast Cancer: An Exploratory Analysis of the HERA Trial"],"prefix":"10.6004","volume":"23","author":[{"given":"Soong June","family":"Bae","sequence":"first","affiliation":[{"name":"Department of Surgery, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea"},{"name":"Institute for Breast Cancer Precision Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sohyun","family":"Moon","sequence":"additional","affiliation":[{"name":"Department of Surgery, Hanyang University Medical Center, Hanyang University College of Medicine, Seoul, Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoonwon","family":"Kook","sequence":"additional","affiliation":[{"name":"Department of Surgery, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea"},{"name":"Institute for Breast Cancer Precision Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Seung Ho","family":"Baek","sequence":"additional","affiliation":[{"name":"Department of Surgery, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea"},{"name":"Institute for Breast Cancer Precision Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Minji","family":"Lee","sequence":"additional","affiliation":[{"name":"Department of Surgery, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea"},{"name":"Institute for Breast Cancer Precision Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joon","family":"Jeong","sequence":"additional","affiliation":[{"name":"Department of Surgery, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea"},{"name":"Institute for Breast Cancer Precision Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sung Gwe","family":"Ahn","sequence":"additional","affiliation":[{"name":"Department of Surgery, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea"},{"name":"Institute for Breast Cancer Precision Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"4047","reference":[{"key":"B1","series-title":"Lancet","first-page":"771","article-title":"Relevance of breast cancer hormone receptors and other factors to the efficacy of adjuvant tamoxifen: patient-level meta-analysis of randomised trials","volume":"378","author":"Davies C","year":"2011","unstructured":"Davies C, Godwin J, Gray R, Relevance of breast cancer hormone receptors and other factors to the efficacy of adjuvant tamoxifen: patient-level meta-analysis of randomised trials. Lancet 2011;378:771\u2013784."},{"key":"B2","series-title":"N Engl J Med","first-page":"436","article-title":"Adjuvant ovarian suppression in premenopausal breast cancer","volume":"372","author":"Francis PA","year":"2015","unstructured":"Francis PA, Regan MM, Fleming GF, Adjuvant ovarian suppression in premenopausal breast cancer. N Engl J Med 2015;372:436\u2013446."},{"key":"B3","series-title":"J Clin Oncol","first-page":"1689","article-title":"Adjuvant endocrine therapy for women with hormone receptor-positive breast cancer: American Society of Clinical Oncology clinical practice guideline update on ovarian suppression","volume":"34","author":"Burstein HJ","year":"2016","unstructured":"Burstein HJ, Lacchetti C, Anderson H, Adjuvant endocrine therapy for women with hormone receptor-positive breast cancer: American Society of Clinical Oncology clinical practice guideline update on ovarian suppression. J Clin Oncol 2016;34:1689\u20131701."},{"key":"B4","series-title":"J Clin Oncol","first-page":"1370","article-title":"Adjuvant endocrine therapy in premenopausal breast cancer: 12-year results from SOFT","volume":"41","author":"Francis PA","year":"2023","unstructured":"Francis PA, Fleming GF, L\u00e1ng I, Adjuvant endocrine therapy in premenopausal breast cancer: 12-year results from SOFT. J Clin Oncol 2023;41:1370\u20131375."},{"key":"B5","series-title":"J Clin Oncol","first-page":"1376","article-title":"Adjuvant exemestane with ovarian suppression in premenopausal breast cancer: long-term follow-up of the combined TEXT and SOFT trials","volume":"41","author":"Pagani O","year":"2023","unstructured":"Pagani O, Walley BA, Fleming GF, Adjuvant exemestane with ovarian suppression in premenopausal breast cancer: long-term follow-up of the combined TEXT and SOFT trials. J Clin Oncol 2023;41:1376\u20131382."},{"key":"B6","series-title":"J Clin Oncol","first-page":"434","article-title":"Adding ovarian suppression to tamoxifen for premenopausal breast cancer: a randomized phase III trial","volume":"38","author":"Kim HA","year":"2020","unstructured":"Kim HA, Lee JW, Nam SJ, Adding ovarian suppression to tamoxifen for premenopausal breast cancer: a randomized phase III trial. J Clin Oncol 2020;38:434\u2013443."},{"key":"B7","series-title":"J Clin Oncol","first-page":"4864","article-title":"Adding ovarian suppression to tamoxifen for premenopausal women with hormone receptor-positive breast cancer after chemotherapy: an 8-year follow-up of the ASTRRA trial","volume":"41","author":"Baek SY","year":"2023","unstructured":"Baek SY, Noh WC, Ahn SH, Adding ovarian suppression to tamoxifen for premenopausal women with hormone receptor-positive breast cancer after chemotherapy: an 8-year follow-up of the ASTRRA trial. J Clin Oncol 2023;41:4864\u20134871."},{"key":"B8","series-title":"CA Cancer J Clin","first-page":"438","article-title":"Breast cancer statistics, 2019","volume":"69","author":"DeSantis CE","year":"2019","unstructured":"DeSantis CE, Ma J, Gaudet MM, Breast cancer statistics, 2019. CA Cancer J Clin 2019;69:438\u2013451."},{"key":"B9","series-title":"Lancet","first-page":"1195","article-title":"11 years\u2019 follow-up of trastuzumab after adjuvant chemotherapy in HER2-positive early breast cancer: final analysis of the HERceptin Adjuvant (HERA) trial","volume":"389","author":"Cameron D","year":"2017","unstructured":"Cameron D, Piccart-Gebhart MJ, Gelber RD, 11 years\u2019 follow-up of trastuzumab after adjuvant chemotherapy in HER2-positive early breast cancer: final analysis of the HERceptin Adjuvant (HERA) trial. 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Estrogen\/HER2 receptor crosstalk in breast cancer: combination therapies to improve outcomes for patients with hormone receptor-positive\/HER2-positive breast cancer. NPJ Breast Cancer 2023;9:45."},{"key":"B12","series-title":"Eur J Cancer","first-page":"178","article-title":"Adjuvant zoledronic acid and letrozole plus ovarian function suppression in premenopausal breast cancer: HOBOE phase 3 randomised trial","volume":"118","author":"Perrone F","year":"2019","unstructured":"Perrone F, De Laurentiis M, De Placido S, Adjuvant zoledronic acid and letrozole plus ovarian function suppression in premenopausal breast cancer: HOBOE phase 3 randomised trial. Eur J Cancer 2019;118:178\u2013186."},{"key":"B13","series-title":"ESMO Open","first-page":"104085.","article-title":"Ten-year update of HOBOE phase III trial comparing triptorelin plus either tamoxifen or letrozole or zoledronic acid + letrozole in premenopausal hormone receptor-positive early breast cancer patients","volume":"10","author":"Gravina A","year":"2025","unstructured":"Gravina A, Gargiulo P, De Laurentiis M, Ten-year update of HOBOE phase III trial comparing triptorelin plus either tamoxifen or letrozole or zoledronic acid + letrozole in premenopausal hormone receptor-positive early breast cancer patients. ESMO Open 2025;10:104085."},{"key":"B14","series-title":"NPJ Breast Cancer","first-page":"6.","article-title":"Type of adjuvant endocrine therapy and disease-free survival in patients with early HR-positive\/HER2-positive BC: analysis from the phase III randomized ShortHER trial","volume":"9","author":"Dieci MV","year":"2023","unstructured":"Dieci MV, Bisagni G, Bartolini S, Type of adjuvant endocrine therapy and disease-free survival in patients with early HR-positive\/HER2-positive BC: analysis from the phase III randomized ShortHER trial. NPJ Breast Cancer 2023;9:6."},{"key":"B15","series-title":"J Natl Cancer Inst","first-page":"86","article-title":"Adjuvant anti-HER2 therapy, treatment-related amenorrhea, and survival in premenopausal HER2- positive early breast cancer patients","volume":"111","author":"Lambertini M","year":"2019","unstructured":"Lambertini M, Campbell C, Bines J, Adjuvant anti-HER2 therapy, treatment-related amenorrhea, and survival in premenopausal HER2- positive early breast cancer patients. J Natl Cancer Inst 2019;111:86\u201394."},{"key":"B16","series-title":"J Clin Oncol","first-page":"1293","article-title":"Absolute improvements in freedom from distant recurrence to tailor adjuvant endocrine therapies for premenopausal women: results from TEXT and SOFT","volume":"38","author":"Pagani O","year":"2020","unstructured":"Pagani O, Francis PA, Fleming GF, Absolute improvements in freedom from distant recurrence to tailor adjuvant endocrine therapies for premenopausal women: results from TEXT and SOFT. J Clin Oncol 2020;38:1293\u20131303."},{"key":"B17","series-title":"ESMO Open","first-page":"100088.","article-title":"Adjuvant endocrine therapy in HER2-positive breast cancer patients: systematic review and meta- analysis","volume":"6","author":"Peleg Hasson S","year":"2021","unstructured":"Peleg Hasson S, Brezis MR, Shachar E, Adjuvant endocrine therapy in HER2-positive breast cancer patients: systematic review and meta- analysis. 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J Clin Oncol 2019;37:862\u2013866."},{"key":"B21","series-title":"J Clin Oncol","first-page":"3113","article-title":"Treatment efficacy, adherence, and quality of life among women younger than 35 years in the International Breast Cancer Study Group TEXT and SOFT adjuvant endocrine therapy trials","volume":"35","author":"Saha P","year":"2017","unstructured":"Saha P, Regan MM, Pagani O, Treatment efficacy, adherence, and quality of life among women younger than 35 years in the International Breast Cancer Study Group TEXT and SOFT adjuvant endocrine therapy trials. J Clin Oncol 2017;35:3113\u20133122."},{"key":"B22","series-title":"Breast Cancer Res Treat","first-page":"183","article-title":"Patient preferences and adherence to adjuvant GnRH analogs among premenopausal women with hormone receptor positive breast cancer","volume":"190","author":"Sukumar JS","year":"2021","unstructured":"Sukumar JS, Quiroga D, Kassem M, Patient preferences and adherence to adjuvant GnRH analogs among premenopausal women with hormone receptor positive breast cancer. Breast Cancer Res Treat 2021;190:183\u2013188."},{"key":"B23","series-title":"J Clin Oncol","first-page":"1584","article-title":"Twelve-month estrogen levels in premenopausal women with hormone receptor-positive breast cancer receiving adjuvant triptorelin plus exemestane or tamoxifen in the Suppression of Ovarian Function Trial (SOFT): the SOFT-EST substudy","volume":"34","author":"Bellet M","year":"2016","unstructured":"Bellet M, Gray KP, Francis PA, Twelve-month estrogen levels in premenopausal women with hormone receptor-positive breast cancer receiving adjuvant triptorelin plus exemestane or tamoxifen in the Suppression of Ovarian Function Trial (SOFT): the SOFT-EST substudy. J Clin Oncol 2016;34:1584\u20131593."},{"key":"B24","series-title":"Ann Oncol","first-page":"159","article-title":"Early breast cancer: ESMO clinical practice guideline for diagnosis, treatment and follow-up","volume":"35","author":"Loibl S","year":"2024","unstructured":"Loibl S, Andr\u00e9 F, Bachelot T, Early breast cancer: ESMO clinical practice guideline for diagnosis, treatment and follow-up. Ann Oncol 2024;35:159\u2013182."},{"key":"B1","series-title":"Lancet","first-page":"771","article-title":"Relevance of breast cancer hormone receptors and other factors to the efficacy of adjuvant tamoxifen: patient-level meta-analysis of randomised trials","volume":"378","author":"Davies C","year":"2011","unstructured":"Davies C, Godwin J, Gray R, Relevance of breast cancer hormone receptors and other factors to the efficacy of adjuvant tamoxifen: patient-level meta-analysis of randomised trials. Lancet 2011;378:771\u2013784."},{"key":"B2","series-title":"N Engl J Med","first-page":"436","article-title":"Adjuvant ovarian suppression in premenopausal breast cancer","volume":"372","author":"Francis PA","year":"2015","unstructured":"Francis PA, Regan MM, Fleming GF, Adjuvant ovarian suppression in premenopausal breast cancer. N Engl J Med 2015;372:436\u2013446."},{"key":"B3","series-title":"J Clin Oncol","first-page":"1689","article-title":"Adjuvant endocrine therapy for women with hormone receptor-positive breast cancer: American Society of Clinical Oncology clinical practice guideline update on ovarian suppression","volume":"34","author":"Burstein HJ","year":"2016","unstructured":"Burstein HJ, Lacchetti C, Anderson H, Adjuvant endocrine therapy for women with hormone receptor-positive breast cancer: American Society of Clinical Oncology clinical practice guideline update on ovarian suppression. J Clin Oncol 2016;34:1689\u20131701."},{"key":"B4","series-title":"J Clin Oncol","first-page":"1370","article-title":"Adjuvant endocrine therapy in premenopausal breast cancer: 12-year results from SOFT","volume":"41","author":"Francis PA","year":"2023","unstructured":"Francis PA, Fleming GF, L\u00e1ng I, Adjuvant endocrine therapy in premenopausal breast cancer: 12-year results from SOFT. J Clin Oncol 2023;41:1370\u20131375."},{"key":"B5","series-title":"J Clin Oncol","first-page":"1376","article-title":"Adjuvant exemestane with ovarian suppression in premenopausal breast cancer: long-term follow-up of the combined TEXT and SOFT trials","volume":"41","author":"Pagani O","year":"2023","unstructured":"Pagani O, Walley BA, Fleming GF, Adjuvant exemestane with ovarian suppression in premenopausal breast cancer: long-term follow-up of the combined TEXT and SOFT trials. J Clin Oncol 2023;41:1376\u20131382."},{"key":"B6","series-title":"J Clin Oncol","first-page":"434","article-title":"Adding ovarian suppression to tamoxifen for premenopausal breast cancer: a randomized phase III trial","volume":"38","author":"Kim HA","year":"2020","unstructured":"Kim HA, Lee JW, Nam SJ, Adding ovarian suppression to tamoxifen for premenopausal breast cancer: a randomized phase III trial. J Clin Oncol 2020;38:434\u2013443."},{"key":"B7","series-title":"J Clin Oncol","first-page":"4864","article-title":"Adding ovarian suppression to tamoxifen for premenopausal women with hormone receptor-positive breast cancer after chemotherapy: an 8-year follow-up of the ASTRRA trial","volume":"41","author":"Baek SY","year":"2023","unstructured":"Baek SY, Noh WC, Ahn SH, Adding ovarian suppression to tamoxifen for premenopausal women with hormone receptor-positive breast cancer after chemotherapy: an 8-year follow-up of the ASTRRA trial. J Clin Oncol 2023;41:4864\u20134871."},{"key":"B8","series-title":"CA Cancer J Clin","first-page":"438","article-title":"Breast cancer statistics, 2019","volume":"69","author":"DeSantis CE","year":"2019","unstructured":"DeSantis CE, Ma J, Gaudet MM, Breast cancer statistics, 2019. CA Cancer J Clin 2019;69:438\u2013451."},{"key":"B9","series-title":"Lancet","first-page":"1195","article-title":"11 years\u2019 follow-up of trastuzumab after adjuvant chemotherapy in HER2-positive early breast cancer: final analysis of the HERceptin Adjuvant (HERA) trial","volume":"389","author":"Cameron D","year":"2017","unstructured":"Cameron D, Piccart-Gebhart MJ, Gelber RD, 11 years\u2019 follow-up of trastuzumab after adjuvant chemotherapy in HER2-positive early breast cancer: final analysis of the HERceptin Adjuvant (HERA) trial. 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Estrogen\/HER2 receptor crosstalk in breast cancer: combination therapies to improve outcomes for patients with hormone receptor-positive\/HER2-positive breast cancer. NPJ Breast Cancer 2023;9:45."},{"key":"B12","series-title":"Eur J Cancer","first-page":"178","article-title":"Adjuvant zoledronic acid and letrozole plus ovarian function suppression in premenopausal breast cancer: HOBOE phase 3 randomised trial","volume":"118","author":"Perrone F","year":"2019","unstructured":"Perrone F, De Laurentiis M, De Placido S, Adjuvant zoledronic acid and letrozole plus ovarian function suppression in premenopausal breast cancer: HOBOE phase 3 randomised trial. 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ESMO Open 2025;10:104085."},{"key":"B14","series-title":"NPJ Breast Cancer","first-page":"6.","article-title":"Type of adjuvant endocrine therapy and disease-free survival in patients with early HR-positive\/HER2-positive BC: analysis from the phase III randomized ShortHER trial","volume":"9","author":"Dieci MV","year":"2023","unstructured":"Dieci MV, Bisagni G, Bartolini S, Type of adjuvant endocrine therapy and disease-free survival in patients with early HR-positive\/HER2-positive BC: analysis from the phase III randomized ShortHER trial. NPJ Breast Cancer 2023;9:6."},{"key":"B15","series-title":"J Natl Cancer Inst","first-page":"86","article-title":"Adjuvant anti-HER2 therapy, treatment-related amenorrhea, and survival in premenopausal HER2- positive early breast cancer patients","volume":"111","author":"Lambertini M","year":"2019","unstructured":"Lambertini M, Campbell C, Bines J, Adjuvant anti-HER2 therapy, treatment-related amenorrhea, and survival in premenopausal HER2- positive early breast cancer patients. J Natl Cancer Inst 2019;111:86\u201394."},{"key":"B16","series-title":"J Clin Oncol","first-page":"1293","article-title":"Absolute improvements in freedom from distant recurrence to tailor adjuvant endocrine therapies for premenopausal women: results from TEXT and SOFT","volume":"38","author":"Pagani O","year":"2020","unstructured":"Pagani O, Francis PA, Fleming GF, Absolute improvements in freedom from distant recurrence to tailor adjuvant endocrine therapies for premenopausal women: results from TEXT and SOFT. J Clin Oncol 2020;38:1293\u20131303."},{"key":"B17","series-title":"ESMO Open","first-page":"100088.","article-title":"Adjuvant endocrine therapy in HER2-positive breast cancer patients: systematic review and meta- analysis","volume":"6","author":"Peleg Hasson S","year":"2021","unstructured":"Peleg Hasson S, Brezis MR, Shachar E, Adjuvant endocrine therapy in HER2-positive breast cancer patients: systematic review and meta- analysis. 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Breast Cancer Res Treat 2021;190:183\u2013188."},{"key":"B23","series-title":"J Clin Oncol","first-page":"1584","article-title":"Twelve-month estrogen levels in premenopausal women with hormone receptor-positive breast cancer receiving adjuvant triptorelin plus exemestane or tamoxifen in the Suppression of Ovarian Function Trial (SOFT): the SOFT-EST substudy","volume":"34","author":"Bellet M","year":"2016","unstructured":"Bellet M, Gray KP, Francis PA, Twelve-month estrogen levels in premenopausal women with hormone receptor-positive breast cancer receiving adjuvant triptorelin plus exemestane or tamoxifen in the Suppression of Ovarian Function Trial (SOFT): the SOFT-EST substudy. J Clin Oncol 2016;34:1584\u20131593."},{"key":"B24","series-title":"Ann Oncol","first-page":"159","article-title":"Early breast cancer: ESMO clinical practice guideline for diagnosis, treatment and follow-up","volume":"35","author":"Loibl S","year":"2024","unstructured":"Loibl S, Andr\u00e9 F, Bachelot T, Early breast cancer: ESMO clinical practice guideline for diagnosis, treatment and follow-up. 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