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Approximately 1 in 3 patients with stage II (N0, N1) ER+ early breast cancer (eBC) will experience distant recurrence—a fact that underscores the inability of today’s treatments to fully address the needs of these patients1,2  

 

UNSEEN RISK

In HR+/HER2- eBC

The number of patients with stage II (N0, N1) disease, and their level of risk, is substantial2,3

 

A sizable proportion of patients3

32% of patients with HR+/HER2- eBC have stage II disease

Estimate based on data from Surveillance, Epidemiology, and End Results (SEER) registries.

See stage II TNM classification

A chart showing the stage II classification of tumor size (T) v the number of lymph nodes involved (N)

Underestimated risk2

~One in three patients with stage II ER+ eBC will experience distant recurrence

 

Although a heterogeneous population, all patients with stage II (N0, N1) ER+ eBC are at risk of distant recurrence1,2,6 

A graph showing the risk of distant recurrence as a percentage for patients with stage II eBC

From a meta-analysis of 78 randomized trials in the Early Breast Cancer Trialists’ Collaborative Group (EBCTCG) database of 74,194 women with ER+ breast cancer who had 5 years of scheduled endocrine therapy. Patients with T0 and T3, and those with N3 disease, were not included in the analysis.1

 

 
Your patients with stage II (N0, N1) eBC need new options that more effectively reduce their risk of recurrence

 

 

TREATMENT GAP

In HR+/HER2- eBC

A gap in treatment innovation leaves most patients with stage II (N0, N1) disease without optimal therapy7,8 

Recently approved treatments are limited to the high-risk setting7-10

abemaciclib and olaparib only address a small portion of stage II HR+/HER2- eBC

Proportion of stage II HR+/HER2– disease estimated to be addressed by recent treatment advancements.

 

 
While abemaciclib and olaparib provide additional options, each is only indicated for use in <15% of patients with eBC3,8,11,12 

 

Percentages calculated based on approval of abemaciclib for stage II or III node-positive disease, and, for olaparib, prevalence of BRCA1 and BRCA2 germline mutations in ER+ breast cancer.

TOLERABILITY CHALLENGES

Tolerability and adherence remain a challenge in HR+/HER2- eBC13-18 

 

Symptomatic adverse reactions are associated with:

  • Inability to carry out activities of daily living
  • Nonadherence to therapy
  • Higher rates of treatment discontinuation
In clinical trials, newer treatment options for HR+/HER2– eBC had higher rates of symptomatic ARs compared with placebo—particularly diarrhea, nausea, and fatigue—that contributed to discontinuation in up to nearly 1 in 5 patients.7,19,20
 
Treatment discontinuation and nonadherence are associated with an increased risk of recurrence, underscoring the need for treatments with improved tolerability14,21,22 

 

 

MIND THE GAP

The substantial risk of distant recurrence for patients with stage II (N0, N1) eBC remains largely unaddressed with today’s treatments2,3,8,11,12,14,19-22

A large proportion of patients with HR+/HER2- eBC have stage II disease, and approximately 1 in 3 will experience distant recurrence

Unseen risk

Stage II (N0, N1) disease accounts for a sizable proportion of HR+/HER2– eBC diagnoses and approximately 1 in 3 patients are at risk of distant recurrence

Recent treatments are estimated to address <15% of patients with stage II HR+/HER2- eBC

Treatment gap

Recently approved treatments are limited in use to <15% of eBC cases, leaving most patients with stage II (N0, N1) disease without an optimized therapy

Up to nearly 1 in 5 patients discontinue these new therapies due to tolerability challenges, leaving them at increased risk of recurrence

Tolerability challenges

Up to nearly 1 in 5 patients discontinue these new therapies due to tolerability challenges—leaving them at increased risk of recurrence

 
Novartis is committed to closing this treatment gap for patients with stage II (N0, N1) HR+/HER2- eBC23,24

 

Definitions & References

ARs, adverse reactions; ER+, estrogen receptor-positive; gBRCAm, germline BRCA–mutated; HER2–, human epidermal growth factor receptor 2-negative; HR+, hormone receptor-positive.

References: 1. Pan H, Gray R, Braybrooke J, et al; EBCTCG. 20-year risks of breast-cancer recurrence after stopping endocrine therapy at 5 years. N Engl J Med. 2017;377(19):1836-1846. doi:10.1056/NEJMoa1701830 2. Pan H, Gray R, Braybrooke J, et al; EBCTCG. 20-year risks of breast-cancer recurrence after stopping endocrine therapy at 5 years. N Engl J Med. 2017;377(19):1836-1846;(suppl). doi:10.1056/NEJMoa1701830 3. Howlader N, Altekruse SF, Li CI, et al. US incidence of breast cancer subtypes defined by joint hormone receptor and HER2 status. J Natl Cancer Inst. 2014;106(5):dju055. doi:10.1093/jnci/dju055 4. Kalli S, Semine A, Cohen S, Naber SP, Makim SS, Bahl M. American Joint Committee on Cancer’s staging system for breast cancer, eighth edition: what the radiologist needs to know. Radiographics. 2018;38(7):1921-1933. doi:10.1148/rg.2018180056 5. Koh J, Kim MJ. Introduction of a new staging system of breast cancer for radiologists: an emphasis on the prognostic stage. Korean J Radiol. 2019;20(1):69-82. doi:10.3348/kjr.2018.0231 6. Lüönd F, Tiede S, Christofori G. Breast cancer as an example of tumour heterogeneity and tumour cell plasticity during malignant progression. Br J Cancer. 2021;125(2):164-175. doi:10.1038/s41416-021-01328-7 7. Johnston SRD, Harbeck N, Hegg R, et al. Abemaciclib combined with endocrine therapy for the adjuvant treatment of HR+, HER2–, node-positive, high-risk, early breast cancer (monarchE). J Clin Oncol. 2020;38(34):3987-3998. doi:10.1200/JCO.20.02514 8. Lynparza [Summary of Product Characteristics]. AstraZeneca AB; 2022. 9. European Medicines Agency. European public assessment reports: Verzenios. Updated April 21, 2022. Accessed October 31, 2022. https://www.ema.europa.eu/en/medicines/human/EPAR/verzenios 10. European Medicines Agency. European public assessment reports: Lynparza. Updated October 3, 2022. Accessed October 31, 2022. https://www.ema.europa.eu/en/medicines/human/EPAR/lynparza 11. Verzenios [Summary of Product Characteristics]. Eli Lilly Nederland B.V.; 2022. 12. Hu C, Hart SN, Gnanaolivu R, et al. A population-based study of genes previously implicated in breast cancer. N Engl J Med. 2021;384(5):440-451. doi:10.1056/NEJMoa2005936 13. Ahmed N, Vengalasetti Y, Haslam A, Prasad V. Association of adjuvant or metastatic setting with discontinuation of cancer drugs in clinical trials. JAMA Netw Open. 2022;5(5):e2212327. doi:10.1001/jamanetworkopen.2022.12327 14. Pistilli B, Lohrisch C, Sheade J, Fleming GF. Personalizing adjuvant endocrine therapy for early-stage hormone receptor-positive breast cancer. Am Soc Clin Oncol Educ Book. 2022;42:60-72. doi:10.1200/EDBK_350358 15. Smith KL, Verma N, Blackford AL, et al. Association of treatment-emergent symptoms identified by patient-reported outcomes with adjuvant endocrine therapy discontinuation. NPJ Breast Cancer. 2022;8(1):53. doi:10.1038/s41523-022-00414-0 16. Brett J, Fenlon D, Boulton M, et al. Factors associated with intentional and unintentional non-adherence to adjuvant endocrine therapy following breast cancer. Eur J Cancer Care (Engl). 2018;27(1). doi:10.1111/ecc.12601 17. Fontein DBY, Nortier JWR, Liefers GJ, et al. High non-compliance in the use of letrozole after 2.5 years of extended adjuvant endocrine therapy. Results from the IDEAL randomized trial. Eur J Surg Oncol. 2012;38(2):110-117. doi:10.1016/j.ejso.2011.11.010 18. Hershman DL, Kushi LH, Shao T, et al. Early discontinuation and nonadherence to adjuvant hormonal therapy in a cohort of 8,769 early-stage breast cancer patients. J Clin Oncol. 2010;28(27):4120-4128. doi:10.1200/JCO.2009.25.9655 19. Tutt ANJ, Garber JE, Kaufman B, et al; OlympiA Clinical Trial Steering Committee and Investigators. Adjuvant olaparib for patients with BRCA1- or BRCA2-mutated breast cancer. N Engl J Med. 2021;384(25):2394-2405. doi:10.1056/NEJMoa2105215 20. Rugo HS, O’Shaughnessy J, Boyle F, et al; monarchE Committee Members. Adjuvant abemaciclib combined with endocrine therapy for high-risk early breast cancer: safety and patient-reported outcomes from the monarchE study. Ann Oncol. 2022;33(6):616-627. doi:10.1016/j.annonc.2022.03.006 21. Collin LJ, Cronin-Fenton DP, Ahern TP, et al. Early discontinuation of endocrine therapy and recurrence of breast cancer among premenopausal women. Clin Cancer Res. 2021;27(5):1421-1428. doi:10.1158/1078-0432.CCR-20-3974 22. Ejlertsen B, Jensen M-B, Mouridsen HT; Danish Breast Cancer Cooperative Group. Excess mortality in postmenopausal high-risk women who only receive adjuvant endocrine therapy for estrogen receptor positive breast cancer. Acta Oncol. 2014;53(2):174-185. doi:10.3109/0284186X.2013.850738 23. A phase III, multicenter, randomized, open-label trial to evaluate efficacy and safety of ribociclib with endocrine therapy as an adjuvant treatment in patients with hormone receptor-positive, HER2-negative, early breast cancer (New Adjuvant TriAl with Ribociclib [LEE011]: NATALEE). EduraCT identifier: 2018-002998-21. Posted January 18, 2019. Accessed November 1, 2022. https://www.clinicaltrialsregister.eu/ctr-search/trial/2018-002998-21/ES 24. A trial to evaluate efficacy and safety of ribociclib with endocrine therapy as adjuvant treatment in patients with HR+/HER2- early breast cancer (NATALEE). ClinicalTrials.gov identifier: NCT03701334. Updated February 18, 2022. Accessed October 31, 2022. https://clinicaltrials.gov/ct2/show/NCT03701334?term=NCT03701334&draw=2&rank=1