Randomized Phase III Study of Adjuvant Endocrine-Therapy with or without Chemotherapy for Postmenopausal Breast Cancer Patients who Responded to Neoadjuvant Letrozole

Conditions

postmenopausal primary breast cancer

Hiroji Iwata, Yutaka Yamamoto, Takehiko Sakai, Yoshie Hasegawa, Rikiya Nakamura et al. (15 authors)

Breast Cancer Research and Treatment2023-03-224 citations

Abstract PD13-09: Primary analysis from NEOS trial: A randomized phase III study that assessed the long-term prognosis of estrogen receptor positive (ER+) primary breast cancer (PBC) pts who received neoadjuvant endocrine therapy (NET) with/without adjuvant chemotherapy (CT)

Hiroji Iwata, Tatsuya Toyama, Naruto Taira, Norikazu Masuda, Yutaka Yamamoto et al. (15 authors)

Cancer Research2022-02-15

10.1158/1538-7445.sabcs21-pd13-09

Distant disease-free survival (DDFS) according to response category in neoadjuvant endocrine therapy (NET): 6-year analysis in phase III NEOS trial

Hiroji Iwata, Norikazu Masuda, Yutaka Yamamoto, Tomomi Fujisawa, Tatsuya Toyama et al. (16 authors)

Annals of Oncology2018-10-01

10.1093/annonc/mdy270.182

Abstract P3-13-03: NEOS: A randomized, open label, phase 3 trial of adjuvant chemotherapy for postmenopausal breast cancer patients who responded to neoadjuvant letrozole: First report of long-term outcome and prognostic value of response to neoadjuvant endocrine therapy

Hiroji Iwata, N Masuda, Tomochika Fujisawa, Tatsuya Toyama, Shoichiro Ohtani et al. (16 authors)

Cancer Research2018-02-15

10.1158/1538-7445.sabcs17-p3-13-03

Taira N, Iwata H, Hasegawa Y, Sakai T, Higaki K, Kihara K, Yamaguchi T, Ohsumi S, Shimozuma K, Ohashi Y.

2014-04-0220 citations

10.1007/s10549-014-2935-5

Interventions

CL(chemotherapy*-letrozole) : letrozole for 4.5-5.0 years (2.5mg/day po QD) after chemotherapy* . *one of the following regimens: CMF, AC, EC, TC, FAC, FEC, AC-T/EC-T, FEC-T, TAC L (letrozole) : let

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Postmenopausal women with histological confirmed invasive breast cancer at diagnosis. The criteria for determining menopause include any of the following: a)Age 60 y b)Age < 60 y and amenorrheic for 12 or more months c)Prior bilateral oophorectomy 2. TNM: T1c-T2, N0, M0. 3. ER-positive by core needle biopsy before treatment. 4. HER2 <=2+ by core needle biopsy before treatment and/or FISH (-) before the registration. 5. Age<=75 years old at the registration. 6. PS(ECOG): 0, 1. 7. No prior treatment for breast cancer before the registration. 8. Adequate main organ functions. WBC >=3,000/mm3, PLT >=100,000/mm3, GOT, GPT <=ULN*2.5, Cre<1.5mg/dL, No concurrent treatment for cerebral infarction at the registration. No history of myocardial infarction and congestive heart failure. No need for treatment of ischemic heart disease and valvular disorder. 9. Written informed consent.

Exclusion criteria

Exclusion criteria: 1. Positive sentinel lymph nodes before the registration. 2. Synchronous or asynchronous bilateral breast cancer. 3. Multifocal breast cancer of plural region 4. Double invasive carcinoma (in less than 5 years after the last treatment). 5. History of breast cancer. 6. Under treatment with continuous systemic steroid, estrogen or SERM. 7. Active participant in any other clinical trial for breast cancer. 8. Patient judged inappropriate for this study by the physicians.

Design outcomes

Primary

Measure	Time frame
Disease-Free Survival(DFS)	—

Secondary

Measure	Time frame
Overall Survival(OS), Clinical response rate for neoadjuvant letrozole, Pathological response, Breast-conserving surgery rate, DFS and OS by the clinical response (CR / PR / SD / PD) of neoadjuvant letrozol, Safety, HRQOL, Cost-Effectiveness(QALY)	—

Countries

Japan

Contacts

Public ContactAkira Yamao

Public Health Research Foundation Comprehensive Support Project for Clinical Research

support@csp.or.jp03-5287-2633

Outcome results

None listed