NCCN VERSION 2 2015

NCCN Guidelines Version 2.2015 Invasive Breast Cancer

NCCN Guidelines Index Breast Cancer Table of Contents Discussion

SYSTEMIC TREATMENT OF RECURRENT OR STAGE IV DISEASE ER and/or PR POSITIVE; HER2 NEGATIVE OR POSITIVE

Ovarian ablation or suppression, plus endocrine therapy as for postmenopausal women zz,aaa

Premenopausal kk

Prior endocrine therapy within 1 y

Postmenopausal kk,yy

Consider initial chemotherapy bbb ( See BINV-20 and BINV-21 )

Visceral crisis

ER and/or PR positive; HER2 negative b

See Follow-up Therapy For Endocrine Treatment of

Ovarian ablation or suppression, plus endocrine therapy as for postmenopausal women zz,aaa or Selective ER modulators zz,aaa Aromatase inhibitor zz,aaa,ccc or Selective ER modulators or selective ER down-regulator zz

ER and/or PR positive; HER2 positive b, yy

Premenopausal kk

Recurrent/Stage IV Disease (BINV-22)

No prior endocrine therapy within 1 y

Postmenopausal kk,yy

Consider initial chemotherapy bbb ( See BINV-20 and BINV-21 )

Visceral crisis

b See Principles of HER2 Testing (BINV-A) . kk See Definition of Menopause (BINV-L) .

yy Limited studies document a progression-free survival advantage of adding trastuzumab or lapatinib to aromatase inhibition in postmenopausal patients with ER-positive, HER2-positive disease. However, no overall survival advantage has been demonstrated. zz See Endocrine Therapy for Recurrent or Stage IV Disease (BINV-M) . aaa It is unclear that women presenting at time of initial diagnosis with metastatic disease will benefit from the performance of palliative local breast surgery and/or radiation therapy. Generally this palliative local therapy should be considered only after response to initial systemic therapy. bbb See Chemotherapy Regimens for Recurrent or Metastatic Breast Cancer (BINV-N) .

ccc A single study (S0226) in women with hormone receptor-positive breast cancer and no prior chemotherapy, biological therapy, or endocrine therapy for metastatic disease demonstrated that the addition of fulvestrant to anastrozole resulted in prolongation of time to progression. Subset analysis suggested that patients without prior adjuvant tamoxifen and more than 10 years since diagnosis experienced the greatest benefit. Two studies with similar design (FACT and SOFEA) demonstrated no advantage in time to progression with the addition of fulvestrant to anastrozole.

Note: All recommendations are category 2A unless otherwise indicated. Clinical Trials: NCCN believes that the best management of any cancer patient is in a clinical trial. Participation in clinical trials is especially encouraged.

BINV-19

Version2.2015, 03/11/2015© National Comprehensive Cancer Network, Inc. 2015,All rights reserved.The NCCN Guidelines ® and this illustration may not be reproduced in any form without the express written permission of NCCN ® .