A phase II, randomized, open-label 3-arm clinical trial of fulvestrant (F) plus goserelin (G) versus anastrozole (A) plus goserelin (G) versus goserelin (G) alone for hormone receptor (HR) positive, tamoxifen (T) pretreated premenopausal women with recurrent or metastatic breast cance r(MBC) (KCSG BR10-04).

Authors

null

Ji-Yeon Kim

Samsung Medical Center, Seoul, Republic of Korea

Ji-Yeon Kim , Seock-Ah Im , Kyung Hae Jung , Jungsil Ro , Joohyuk Sohn , Jee Hyun Kim , Yeon Hee Park , Tae Yong Kim , Sung-Bae Kim , Keun-Seok Lee , Gun Min Kim , Se Hyun Kim , Jin Seok Ahn , Kyung-Hun Lee , Jin-Hee Ahn , In Hae Park , Young-Hyuck Im

Organizations

Samsung Medical Center, Seoul, Republic of Korea, Seoul National University, Seoul, Republic of Korea, Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea, National Cancer Center, Goyang-Si, South Korea, Yonsei Cancer Center, Seoul, Republic of Korea, Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea, Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul, Republic of Korea, National Cancer Center, Gyeonggi-do, South Korea, Yonsei University, Seoul, South Korea, Division of Hematology and Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea, Seoul National University Hospital, Seoul, Republic of Korea, Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea, Center for Breast Cancer, National Cancer Center, Goyangsi, South Korea, Samsung Medical Center, Seoul, South Korea

Research Funding

Pharmaceutical/Biotech Company

Background: Endocrine therapy(ET) is the preferred treatment for HR(+) MBC. For premenopausal patients who were pretreated with T, ovarian function suppression with G ± aromatase inhibitor(A.I.) is a reasonable option. Fulvestrant yields favorable outcomes in postmenopausal women with MBC. We investigated the efficacy and safety of F+G and A+G in comparison with G alone in premenopausal women with HR(+), T-pretreated MBC. Methods: In this multicenter, open-label, randomized phase 2 study, women > 18 years with HR(+), T-pretreated MBC were stratified by presence of visceral metastasis and recurrence within or after 1 year of completion of adjuvant T. Premenopausal women with T-pretreated MBC eligible for ET were randomly assigned (1:1:1) to F+G (F 500 mg IM + G 3.6 mg SC Q 4 wks), or A +G (A 1 mg P.O. qd + G 3.6 mg SC Q 4 wks) or G (G 3.6 mg SC Q 4 wks). The primary endpoint was time to progression(TTP), analyzed by intention to treat with log-rank test. Secondary endpoints included overall survival, overall response rate, clinical benefit rate and toxicities according to NCI CTCAE v3.0 (ClinicalTrials.gov, No. NCT01266213). Results: Of 138 eligible pts, 44 were randomly assigned to F+G, 47 to A+G, 47 to G. The median duration of follow-up was 28.8 months(mo) and median age was 43 (range; 23.0-55.0). The median TTP was 16.3 mo(95% C.I. 7.5-25.1) for F+G, 14.5 mo(95% C.I. 11.0-18.0) for A+G, and 13.5 mo(95% C.I. 10.3-16.8) for G alone, respectively. For the comparison of each experimental arm to control arm, 24-mo TTP were analyzed: F+G vs G(%±SE): 40.5±7.5 vs. 25.3±7.0, one-sided P = 0.048, A+G vs G(%±SE): 23.9±7.2 vs. 25.3±7.0, one-sided P = 0.304. Grade 3/4 toxicities were rarely observed. Most common adverse events were grade 1 joint stiffness and arthralgia which were more frequently observed in F+G compared to A+G and G (P = 0.018 and 0.015, respectively). Conclusions: The combination of F+G as well as G ±A.I. might be a valid option for HR(+) premenopausal women with T-pretreated MBC and further investigation is warranted. Clinical trial information: NCT01266213

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Abstract Details

Meeting

2017 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Breast Cancer—Metastatic

Track

Breast Cancer

Sub Track

Hormone Receptor-Positive

Clinical Trial Registration Number

NCT01266213

Citation

J Clin Oncol 35, 2017 (suppl; abstr 1041)

DOI

10.1200/JCO.2017.35.15_suppl.1041

Abstract #

1041

Poster Bd #

33

Abstract Disclosures