Journal Article
. 2014 Dec;372(5).
doi: 10.1056/NEJMoa1412379.

Adjuvant ovarian suppression in premenopausal breast cancer

Prudence A Francis 1 Meredith M Regan  Gini F Fleming  István Láng  Eva Ciruelos  Meritxell Bellet  Hervé R Bonnefoi  Miguel A Climent  Gian Antonio Da Prada  Harold J Burstein  Silvana Martino  Nancy E Davidson  Charles E Geyer  Barbara A Walley  Robert Coleman  Pierre Kerbrat  Stefan Buchholz  James N Ingle  Eric P Winer  Manuela Rabaglio-Poretti  Rudolf Maibach  Barbara Ruepp  Anita Giobbie-Hurder  Karen N Price  Marco Colleoni  Giuseppe Viale  Alan S Coates  Aron Goldhirsch  Richard D Gelber  SOFT Investigators  International Breast Cancer Study Group  
  • PMID: 25495490
  •     17 References
  •     155 citations


Background: Suppression of ovarian estrogen production reduces the recurrence of hormone-receptor-positive early breast cancer in premenopausal women, but its value when added to tamoxifen is uncertain.

Methods: We randomly assigned 3066 premenopausal women, stratified according to prior receipt or nonreceipt of chemotherapy, to receive 5 years of tamoxifen, tamoxifen plus ovarian suppression, or exemestane plus ovarian suppression. The primary analysis tested the hypothesis that tamoxifen plus ovarian suppression would improve disease-free survival, as compared with tamoxifen alone. In the primary analysis, 46.7% of the patients had not received chemotherapy previously, and 53.3% had received chemotherapy and remained premenopausal.

Results: After a median follow-up of 67 months, the estimated disease-free survival rate at 5 years was 86.6% in the tamoxifen-ovarian suppression group and 84.7% in the tamoxifen group (hazard ratio for disease recurrence, second invasive cancer, or death, 0.83; 95% confidence interval [CI], 0.66 to 1.04; P=0.10). Multivariable allowance for prognostic factors suggested a greater treatment effect with tamoxifen plus ovarian suppression than with tamoxifen alone (hazard ratio, 0.78; 95% CI, 0.62 to 0.98). Most recurrences occurred in patients who had received prior chemotherapy, among whom the rate of freedom from breast cancer at 5 years was 82.5% in the tamoxifen-ovarian suppression group and 78.0% in the tamoxifen group (hazard ratio for recurrence, 0.78; 95% CI, 0.60 to 1.02). At 5 years, the rate of freedom from breast cancer was 85.7% in the exemestane-ovarian suppression group (hazard ratio for recurrence vs. tamoxifen, 0.65; 95% CI, 0.49 to 0.87).

Conclusions: Adding ovarian suppression to tamoxifen did not provide a significant benefit in the overall study population. However, for women who were at sufficient risk for recurrence to warrant adjuvant chemotherapy and who remained premenopausal, the addition of ovarian suppression improved disease outcomes. Further improvement was seen with the use of exemestane plus ovarian suppression. (Funded by Pfizer and others; SOFT number, NCT00066690.).

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Support Care Cancer, 2017 Oct 25; 26(3). PMID: 29063390    Free PMC article.
Talking about women's sexual health after cancer: Why is it so hard to move the needle?
Jennifer Barsky Reese, Sharon L Bober, Mary B Daly.
Cancer, 2017 Nov 09; 123(24). PMID: 29116655    Free PMC article.
The utility of anti-Müllerian hormone in the diagnosis and prediction of loss of ovarian function following chemotherapy for early breast cancer.
R A Anderson, J Mansi, +2 authors, R C F Leonard.
Eur J Cancer, 2017 Nov 09; 87. PMID: 29117576    Free PMC article.
Triptorelin: A Review of its Use as an Adjuvant Anticancer Therapy in Early Breast Cancer.
James E Frampton.
Drugs, 2017 Nov 28; 77(18). PMID: 29177573
Letrozole-induced hepatitis with autoimmune features: a rare adverse drug reaction with review of the relevant literature.
Bharatsinh Gharia, Karan Seegobin, +3 authors, Lara Zuberi.
Oxf Med Case Reports, 2017 Dec 13; 2017(11). PMID: 29230302    Free PMC article.
Impact on disease-free survival of the duration of ovarian function suppression, as postoperative adjuvant therapy, in premenopausal women with hormone receptor-positive breast cancer: a retrospective single-institution study.
Yukinori Ozaki, Yuko Tanabe, +6 authors, Toshimi Takano.
Breast Cancer, 2018 Jan 23; 25(3). PMID: 29357022    Free PMC article.
Spotlight on triptorelin in the treatment of premenopausal women with early-stage breast cancer.
Marta Venturelli, Giorgia Guaitoli, Claudia Omarini, Luca Moscetti.
Breast Cancer (Dove Med Press), 2018 Mar 20; 10. PMID: 29551913    Free PMC article.
Controversies in oncology: which adjuvant endocrine therapy is to be given to premenopausal patients with hormone receptor-positive breast cancer?
Matteo Lambertini, Giulia Viglietti, Evandro de Azambuja.
ESMO Open, 2018 Apr 11; 3(3). PMID: 29636992    Free PMC article.
Current Status of Neoadjuvant Endocrine Therapy in Early Stage Breast Cancer.
Tomás Reinert, Rodrigo Gonçalves, Matthew J Ellis.
Curr Treat Options Oncol, 2018 Apr 18; 19(5). PMID: 29663173
Current Status of Extended Adjuvant Endocrine Therapy in Early Stage Breast Cancer.
Irene E G van Hellemond, Sandra M E Geurts, Vivianne C G Tjan-Heijnen.
Curr Treat Options Oncol, 2018 Apr 29; 19(5). PMID: 29704066    Free PMC article.
Aromatase inhibitors in premenopausal women with breast cancer: the state of the art and future prospects.
M Pistelli, A Della Mora, Z Ballatore, R Berardi.
Curr Oncol, 2018 May 03; 25(2). PMID: 29719441    Free PMC article.
Systematic Review.
International Consensus on the Clinical Management of Inflammatory Breast Cancer from the Morgan Welch Inflammatory Breast Cancer Research Program 10th Anniversary Conference.
Naoto T Ueno, Jose Rodrigo Espinosa Fernandez, +19 authors, Wendy A Woodward.
J Cancer, 2018 May 04; 9(8). PMID: 29721054    Free PMC article.
Practical consensus recommendations on ovarian suppression in early breast cancer (adjuvant).
M Singhal, T P Sahoo, +8 authors, Purvish M Parikh.
South Asian J Cancer, 2018 May 04; 7(2). PMID: 29721484    Free PMC article.
Efficacy and Safety of Neoadjuvant Treatment with Bevacizumab, Liposomal Doxorubicin, Cyclophosphamide and Paclitaxel Combination in Locally/Regionally Advanced, HER2-Negative, Grade III at Premenopausal Status Breast Cancer: A Phase II Study.
Ekaterini C Tampaki, Athanasios Tampakis, +4 authors, Dimitrios T Trafalis.
Clin Drug Investig, 2018 May 11; 38(7). PMID: 29744672
Adjuvant Chemotherapy Guided by a 21-Gene Expression Assay in Breast Cancer.
Joseph A Sparano, Robert J Gray, +27 authors, George W Sledge.
N Engl J Med, 2018 Jun 05; 379(2). PMID: 29860917    Free PMC article.
Highly Cited.
Tailoring Adjuvant Endocrine Therapy for Premenopausal Breast Cancer.
Prudence A Francis, Olivia Pagani, +34 authors, SOFT and TEXT Investigators and the International Breast Cancer Study Group.
N Engl J Med, 2018 Jun 05; 379(2). PMID: 29863451    Free PMC article.
Highly Cited.
Clinical practice guidelines in breast cancer.
N Kumar Tyagi, S Dhesy-Thind.
Curr Oncol, 2018 Jun 19; 25(Suppl 1). PMID: 29910658    Free PMC article.
Endocrine Therapy in Premenopausal Hormone Receptor Positive/Human Epidermal Growth Receptor 2 Negative Metastatic Breast Cancer: Between Guidelines and Literature.
Richard Tancredi, Jenny Furlanetto, Sibylle Loibl.
Oncologist, 2018 Jun 24; 23(8). PMID: 29934412    Free PMC article.
Cancer Treatment-Induced Bone Loss in Women With Breast Cancer and Men With Prostate Cancer.
Pamela Taxel, Erika Faircloth, Sana Idrees, Catherine Van Poznak.
J Endocr Soc, 2018 Jun 27; 2(7). PMID: 29942922    Free PMC article.
Improving medication adherence with adjuvant aromatase inhibitor in women with breast cancer: study protocol of a randomised controlled trial to evaluate the effect of short message service (SMS) reminder.
Yunxin He, Eng Hooi Tan, +4 authors, Bee Choo Tai.
BMC Cancer, 2018 Jul 11; 18(1). PMID: 29986672    Free PMC article.
Cost-effectiveness of monitoring endoxifen levels in breast cancer patients adjuvantly treated with tamoxifen.
M van Nuland, R A Vreman, +5 authors, A M Hövels.
Breast Cancer Res Treat, 2018 Jul 15; 172(1). PMID: 30006796    Free PMC article.
Endocrine therapy for breast cancer in the primary care setting.
A Awan, K Esfahani.
Curr Oncol, 2018 Aug 17; 25(4). PMID: 30111969    Free PMC article.
Breast cancer in adolescents and young adults.
Rebecca H Johnson, Carey K Anders, +2 authors, Archie Bleyer.
Pediatr Blood Cancer, 2018 Aug 30; 65(12). PMID: 30156052    Free PMC article.
An Italian Delphi study to evaluate consensus on adjuvant endocrine therapy in premenopausal patients with breast cancer: the ERA project.
Giacomo Pelizzari, Grazia Arpino, +8 authors, Fabio Puglisi.
BMC Cancer, 2018 Sep 29; 18(1). PMID: 30261866    Free PMC article.
The predictive ability of plasma ESR1 mutations for the efficacy of endocrine therapy in hormone-receptor-positive advanced breast cancer.
Yangfan Du, Na Li, +2 authors, Shunchao Yan.
Onco Targets Ther, 2018 Oct 03; 11. PMID: 30275706    Free PMC article.
Update Breast Cancer 2018 (Part 3) - Genomics, Individualized Medicine and Immune Therapies - in the Middle of a New Era: Prevention and Treatment Strategies for Early Breast Cancer.
Achim Wöckel, Michael P Lux, +17 authors, Hans-Christian Kolberg.
Geburtshilfe Frauenheilkd, 2018 Dec 01; 78(11). PMID: 30498278    Free PMC article.
Adjuvant Systemic Treatment of Premenopausal Women With Hormone Receptor-Positive Early Breast Cancer: Lights and Shadows.
Meredith M Regan, Gini F Fleming, +2 authors, Olivia Pagani.
J Clin Oncol, 2019 Feb 28; 37(11). PMID: 30811287    Free PMC article.
Clinical Features and Outcomes of Invasive Breast Cancer: Age-Specific Analysis of a Modern Hospital-Based Registry.
Ji-Yeon Kim, Danbee Kang, +9 authors, Yeon Hee Park.
J Glob Oncol, 2019 Jul 02; 5. PMID: 31260394    Free PMC article.
Survival outcome of combined GnRH agonist and tamoxifen is comparable to that of sequential adriamycin and cyclophosphamide chemotherapy plus tamoxifen in premenopausal patients with early breast cancer.
Doonyapat Sa-Nguanraksa, Thitikon Krisorakun, Wanee Pongthong, Pornchai O-Charoenrat.
Mol Clin Oncol, 2019 Oct 18; 11(5). PMID: 31620283    Free PMC article.
St. Gallen/Vienna 2019: A Brief Summary of the Consensus Discussion on the Optimal Primary Breast Cancer Treatment.
Marija Balic, Christoph Thomssen, +2 authors, Nadia Harbeck.
Breast Care (Basel), 2019 Dec 05; 14(2). PMID: 31798382    Free PMC article.
Clinical Studies Investigating the Use of Leuprorelin in Breast Cancer Patients from Asia
Wonshik Han, Hyun Jo Youn.
Asian Pac J Cancer Prev, 2019 May 28; 20(5). PMID: 31127911    Free PMC article.
Breast Cancer Index and prediction of benefit from extended endocrine therapy in breast cancer patients treated in the Adjuvant Tamoxifen-To Offer More? (aTTom) trial.
J M S Bartlett, D C Sgroi, +8 authors, D W Rea.
Ann Oncol, 2019 Sep 11; 30(11). PMID: 31504126    Free PMC article.
ClinOmicsTrailbc: a visual analytics tool for breast cancer treatment stratification.
Lara Schneider, Tim Kehl, +13 authors, Hans-Peter Lenhof.
Bioinformatics, 2019 May 01; 35(24). PMID: 31038669    Free PMC article.
Evaluation of Prognosis in Hormone Receptor-Positive/HER2-Negative and Lymph Node-Negative Breast Cancer With Low Oncotype DX Recurrence Score.
Jane Meisel, Chao Zhang, +7 authors, Xiaoxian Li.
Clin Breast Cancer, 2018 Jan 07; 18(5). PMID: 29305309    Free PMC article.
Exercise therapies for preventing or treating aromatase inhibitor-induced musculoskeletal symptoms in early breast cancer.
Kate E Roberts, Kirsty Rickett, +2 authors, Natasha E Woodward.
Cochrane Database Syst Rev, 2020 Jan 30; 1. PMID: 31994181    Free PMC article.
Systematic Review.
Comparison of 21-gene assay and St.Gallen International Expert Consensus in the treatment decision for patients with early invasive breast cancers.
Ming Luo, Fu Li, +2 authors, Jian Zeng.
Cancer Biol Ther, 2019 Oct 31; 21(2). PMID: 31663437    Free PMC article.
Clinical and Genomic Risk to Guide the Use of Adjuvant Therapy for Breast Cancer.
Joseph A Sparano, Robert J Gray, +27 authors, George W Sledge.
N Engl J Med, 2019 Jun 04; 380(25). PMID: 31157962    Free PMC article.
Highly Cited.
Adjuvant Anti-HER2 Therapy, Treatment-Related Amenorrhea, and Survival in Premenopausal HER2-Positive Early Breast Cancer Patients.
Matteo Lambertini, Christine Campbell, +19 authors, Evandro de Azambuja.
J Natl Cancer Inst, 2018 Jun 08; 111(1). PMID: 29878225    Free PMC article.
Prognostic Impact of the 21-Gene Recurrence Score Assay Among Young Women With Node-Negative and Node-Positive ER-Positive/HER2-Negative Breast Cancer.
Philip D Poorvu, Shari I Gelber, +12 authors, Ann H Partridge.
J Clin Oncol, 2019 Dec 07; 38(7). PMID: 31809240    Free PMC article.
Incidence and Survival Among Young Women With Stage I-III Breast Cancer: SEER 2000-2015.
Alexandra Thomas, Anthony Rhoads, +7 authors, Paul A Romitti.
JNCI Cancer Spectr, 2019 Aug 09; 3(3). PMID: 31392297    Free PMC article.
Acupuncture for Hot Flashes in Cancer Patients: Clinical Characteristics and Traditional Chinese Medicine Diagnosis as Predictors of Treatment Response.
Wenli Liu, Aiham Qdaisat, +10 authors, Lorenzo Cohen.
Integr Cancer Ther, 2019 May 03; 18. PMID: 31046489    Free PMC article.
Ovarian suppression for adjuvant treatment of hormone receptor-positive early breast cancer.
Kim Tam Bui, Melina L Willson, +2 authors, Annabel Goodwin.
Cochrane Database Syst Rev, 2020 Mar 07; 3. PMID: 32141074    Free PMC article.
Systematic Review.
Agranulocytosis Induced by Tamoxifen in a Breast Cancer Patient.
Hugo Herrscher, Julie Leblanc, Thierry Petit.
Breast Care (Basel), 2020 Apr 02; 15(1). PMID: 32231501    Free PMC article.
Effect of Tamoxifen on the Risk of Osteoporosis and Osteoporotic Fracture in Younger Breast Cancer Survivors: A Nationwide Study.
Jihyoun Lee, Heba M Alqudaihi, +11 authors, Il Yong Chung.
Front Oncol, 2020 Apr 09; 10. PMID: 32266146    Free PMC article.
Absolute Improvements in Freedom From Distant Recurrence to Tailor Adjuvant Endocrine Therapies for Premenopausal Women: Results From TEXT and SOFT.
Olivia Pagani, Prudence A Francis, +13 authors, SOFT and TEXT Investigators and International Breast Cancer Study Group.
J Clin Oncol, 2019 Oct 17; 38(12). PMID: 31618131    Free PMC article.
Issues with Fertility in Young Women with Breast Cancer.
Nicole Christian, Mary L Gemignani.
Curr Oncol Rep, 2019 May 18; 21(7). PMID: 31098718
Current State of the Art in the Adjuvant Systemic Treatment of Premenopausal Patients With Early Breast Cancer.
Francesca Parisi, Maria Grazia Razeti, +7 authors, Matteo Lambertini.
Clin Med Insights Oncol, 2020 Jul 11; 14. PMID: 32647477    Free PMC article.
Management of hormone receptor-positive, HER2-negative early breast cancer.
Elaine M Walsh, Karen L Smith, Vered Stearns.
Semin Oncol, 2020 Jun 18; 47(4). PMID: 32546323    Free PMC article.
Chemotherapy-Induced Cognitive Impairment Is Associated with Increased Inflammation and Oxidative Damage in the Hippocampus.
Ciara Bagnall-Moreau, Sovira Chaudhry, +2 authors, Karen Hubbard.
Mol Neurobiol, 2019 Apr 17; 56(10). PMID: 30989632    Free PMC article.
Estimation of historical control rate for a single arm de-escalation study - Application to the POSITIVE trial.
Zhuoxin Sun, Samuel M Niman, +9 authors, POSITIVE Steering Committee.
Breast, 2020 Jun 15; 53. PMID: 32535486    Free PMC article.
The healthcare value of the Magee Decision Algorithm™: use of Magee Equations™ and mitosis score to safely forgo molecular testing in breast cancer.
Rohit Bhargava, Beth Z Clark, +2 authors, David J Dabbs.
Mod Pathol, 2020 Mar 24; 33(8). PMID: 32203092    Free PMC article.
Oophorectomy as a Hormonal Ablation Therapy in Metastatic and Recurrent Breast Cancer: Current Indications and Results.
Islam H Metwally, Omar Hamdy, +2 authors, Dina M Elsaid.
Indian J Surg Oncol, 2019 Sep 10; 10(3). PMID: 31496608    Free PMC article.
Application of the ESMO-Magnitude of Clinical Benefit Scale (V.1.1) to the field of early breast cancer therapies.
Shani Paluch-Shimon, Nathan I Cherny, +4 authors, Fatima Cardoso.
ESMO Open, 2020 Sep 08; 5(5). PMID: 32893189    Free PMC article.
Advances in Targeted Therapy for Breast Cancer.
Andrew S Mener, Anita Aggarwal.
Fed Pract, 2015 May 01; 32(Suppl 4). PMID: 30766121    Free PMC article.
Cardiometabolic Effects of Endocrine Treatment of Estrogen Receptor-Positive Early Breast Cancer.
Yee-Ming Cheung, Sabashini K Ramchand, Belinda Yeo, Mathis Grossmann.
J Endocr Soc, 2019 Jul 02; 3(7). PMID: 31259291    Free PMC article.
Cancer Treatment-Related Infertility: A Critical Review of the Evidence.
Philip D Poorvu, A Lindsay Frazier, +6 authors, Ann H Partridge.
JNCI Cancer Spectr, 2019 Jul 31; 3(1). PMID: 31360893    Free PMC article.
GnRHa for Ovarian Protection and the Association between AMH and Ovarian Function during Adjuvant Chemotherapy for Breast Cancer.
Ying Zhong, Yan Lin, +11 authors, Qiang Sun.
J Cancer, 2019 Aug 16; 10(18). PMID: 31413747    Free PMC article.
Fertility Preservation Using GnRH Agonists: Rationale, Possible Mechanisms, and Explanation of Controversy.
Zeev Blumenfeld.
Clin Med Insights Reprod Health, 2019 Sep 07; 13. PMID: 31488958    Free PMC article.
Endocrine Therapy in Early Breast Cancer.
Katja Krauss, Elmar Stickeler.
Breast Care (Basel), 2020 Sep 29; 15(4). PMID: 32982643    Free PMC article.
Guidance and Standards for Breast Cancer Care in Europe.
Rudy Leon De Wilde, Rajesh Devassy, +3 authors, Cristina Cezar.
J Obstet Gynaecol India, 2020 Oct 13; 70(5). PMID: 33041548    Free PMC article.
Clinical utility of genomic signatures in young breast cancer patients: a systematic review.
Cynthia Villarreal-Garza, Ana S Ferrigno, +3 authors, Hatem A Azim.
NPJ Breast Cancer, 2020 Oct 17; 6. PMID: 33062888    Free PMC article.
The Prognostic Impact of Age at Diagnosis Upon Breast Cancer of Different Immunohistochemical Subtypes: A Surveillance, Epidemiology, and End Results (SEER) Population-Based Analysis.
Shibin Cai, Wenjia Zuo, +5 authors, Shuzheng Chen.
Front Oncol, 2020 Oct 20; 10. PMID: 33072554    Free PMC article.
CYP27A1 expression is associated with risk of late lethal estrogen receptor-positive breast cancer in postmenopausal patients.
Siker Kimbung, Maria Inasu, +8 authors, Signe Borgquist.
Breast Cancer Res, 2020 Nov 13; 22(1). PMID: 33176848    Free PMC article.
Simplified phenotyping of CYP2D6 for tamoxifen treatment using the N-desmethyl-tamoxifen/ endoxifen ratio.
Clara Inkyung Lee, Siew Kee Low, +14 authors, Howard Gurney.
Breast, 2020 Nov 09; 54. PMID: 33161337    Free PMC article.
HER2 positivity is not associated with adverse prognosis in high-risk estrogen receptor-positive early breast cancer patients treated with chemotherapy and trastuzumab.
Shuai Li, Jiayi Wu, +6 authors, Kunwei Shen.
Breast, 2020 Nov 10; 54. PMID: 33166784    Free PMC article.
Overexpression of serum exosomal HOTAIR is correlated with poor survival and poor response to chemotherapy in breast cancer patients.
Shicong Tang, Kai Zheng, +3 authors, Dequan Liu.
J Biosci, 2019 Jun 11; 44(2). PMID: 31180050
Identification of predictors based on drug targets highlights accurate treatment of goserelin in breast and prostate cancer.
Yue Zhao, Huimin Sun, +2 authors, Dongwei Zhang.
Cell Biosci, 2021 Jan 08; 11(1). PMID: 33407865    Free PMC article.
Therapy Algorithms for the Diagnosis and Treatment of Patients with Early and Advanced Breast Cancer.
Andreas Schneeweiss, Ingo Bauerfeind, +5 authors, Volkmar Müller.
Breast Care (Basel), 2021 Jan 16; 15(6). PMID: 33447235    Free PMC article.
Breast cancer in very young women-a multicenter 10-year experience.
I F Eiriz, M Vaz Batista, +3 authors, S Braga.
ESMO Open, 2021 Jan 06; 6(1). PMID: 33399090    Free PMC article.
The development of endoxifen for breast cancer.
Matthew P Goetz.
Clin Adv Hematol Oncol, 2018 May 10; 16(2). PMID: 29741509    Free PMC article.
Effect of tamoxifen with or without gonadotropin-releasing hormone analog on DXA values in women with breast cancer.
Eun Heui Kim, Yun Kyung Jeon, +5 authors, Keunyoung Kim.
Sci Rep, 2021 Feb 11; 11(1). PMID: 33564017    Free PMC article.
The Breast Cancer Stem Cells Traits and Drug Resistance.
Qinghui Zheng, Mengdi Zhang, +2 authors, Xuli Meng.
Front Pharmacol, 2021 Feb 16; 11. PMID: 33584277    Free PMC article.
Efficacy of Endocrine Therapy for the Treatment of Breast Cancer in Men: Results from the MALE Phase 2 Randomized Clinical Trial.
Mattea Reinisch, Sabine Seiler, +18 authors, Sibylle Loibl.
JAMA Oncol, 2021 Feb 05;. PMID: 33538790    Free PMC article.