University of Sussex

File(s) not publicly available

NEOCENT: a randomised feasibility and translational study comparing neoadjuvant endocrine therapy with chemotherapy in ER-rich postmenopausal primary breast cancer

journal contribution
posted on 2023-06-08, 19:14 authored by C Palmieri, S Cleator, L S Kilburn, S B Kim, S H Ahn, M Beresford, G Gong, J Mansi, E Mallon, S Reed, K Mousa, Lesley FallowfieldLesley Fallowfield, M Cheang, J Morden, K Page, D S Guttery, B Rghebi, L Primrose, J A Shaw, A M Thompson, J M Bliss, R C Coombes
Neoadjuvant endocrine therapy is an alternative to chemotherapy for women with oestrogen receptor (ER)-positive early breast cancer (BC). We aimed to assess feasibility of recruiting patients to a study comparing chemotherapy versus endocrine therapy in postmenopausal women with ER-rich primary BC, and response as well as translational endpoints were assessed. Patients requiring neoadjuvant therapy were randomised to chemotherapy: 6 x 3-weekly cycles FE100C or endocrine therapy: letrozole 2.5 mg, daily for 18-23 weeks. Primary endpoints were recruitment feasibility and tissue collection. Secondary endpoints included clinical, radiological and pathological response rates, quality of life and translational endpoints. 63/80 patients approached were eligible, of those 44 (70, 95 % CI 57-81) were randomised. 12 (54.5, 95 % CI 32.2-75.6) chemotherapy patients showed radiological objective response compared with 13 (59.1, 95 % CI 36.4-79.3) letrozole patients. Compared with baseline, mean Ki-67 levels fell in both groups at days 2-4 and at surgery [fold change: 0.24 (95 % CI 0.12-0.51) and 0.24; (95 % CI 0.15-0.37), respectively]. Plasma total cfDNA levels rose from baseline to week 8 [fold change: chemotherapy 2.10 (95 % CI 1.47-3.00), letrozole 1.47(95 % CI 0.98-2.20)], and were maintained at surgery in the chemotherapy group [chemotherapy 2.63; 95 % CI 1.56-4.41), letrozole 0.95 (95 % CI 0.71-1.26)]. An increase in plasma let-7a miRNA was seen at surgery for patients with objective radiological response to chemotherapy. Recruitment and tissue collection endpoints were met; however, a larger trial was deemed unfeasible due to slow accrual. Both regimens were equally efficacious. Dynamic changes were seen in Ki-67 and circulating biomarkers in both groups with increases in cfDNA and let-7a miRNA persisting until surgery for chemotherapy patients.


Cancer Research UK; C37/A9356


Cancer Research UK; C14315/A13462


Publication status

  • Published


Breast Cancer Research and Treatment









Page range


Department affiliated with

  • Sussex Health Outcomes Research & Education in Cancer (SHORE-C) Publications

Full text available

  • No

Peer reviewed?

  • Yes

Legacy Posted Date


Usage metrics

    University of Sussex (Publications)


    No categories selected