A Pilot Phase II Study of Neoadjuvant Fulvestrant Plus Abemaciclib in Women With Advanced Low Grade Serous Carcinoma

Trial ID # NCT03531645
Phase II
Drug Class Hormonal Therapy: ER Antagonists
Drug Name Fulvestrant
Alternate Drug Names ZD9238, ICI 182,780, Faslodex
Drugs in Trial Abemaciclib, Fulvestrant
Eligible Participant

Newly diagnosed stage III/IV unresectable low grade serous ovarian cancer

Patients Enrolled


Therapy Setting


Study Design

Open-Label, Non-randomized


ORR, DCR, evaluated per RECIST


ORR: 60% (1CR, 7PR)
DCR: 100% (1CR, 7PR, 7SD)

7 patients w/ IDS:
100% achieved optimal cytoreduction at IDS
(71% R0, 29% R1)

Clinically Significant Adverse Events

Serious AE: none
Grade 3-4 AE: overall (13.3%)


Neoadjuvant treatment with fulvestrant and abemaciclib is tolerable and demonstrates unprecedented response and complete gross resection rates in Low Grade Serous ovarian cancer


Cobb LP et al. A pilot phase II study of neoadjuvant fulvestrant plus abemaciclib in women with advanced low-grade serous carcinoma. J Clin Oncol 40, 2022 (suppl 16; abstr 5522)

Cobb LP et al. Poster

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