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Ann Oncol. 2013 Oct;24(10):2543-8. doi: 10.1093/annonc/mdt216. Epub 2013 Jun 20.

Randomized phase II study of lonaprisan as second-line therapy for progesterone receptor-positive breast cancer.

Author information

1
Department of Gynaecology and Obstetrics, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany.

Abstract

BACKGROUND:

The progesterone-receptor (PR) antagonists onapristone (type I) and mifepristone (type II) showed modest activity in hormone-receptor-positive breast cancer; however, onapristone in particular was associated with hepatotoxicity. Lonaprisan is a novel, type III PR antagonist that was well tolerated in phase I studies.

PATIENTS AND METHODS:

This randomized, open-label, phase II study evaluated the efficacy and tolerability of lonaprisan as second-line endocrine therapy in postmenopausal women with stage IV, PR-positive, HER2-negative, metastatic breast cancer.

RESULTS:

Patients received once-daily lonaprisan 25 mg (n = 34) or 100 mg (n = 34). The primary objective was not met (≥ 35% clinical benefit rate: complete/partial responses at any time until month 6 or stable disease [SD] for ≥ 6 months from start of treatment). There were no complete/partial responses. In the 25 mg and 100 mg groups, 6 of 29 patients (21%) and 2 of 29 patients (7%), respectively, had SD ≥ 6 months. Overall, 61 of 68 patients (90%) had ≥ 1 adverse event (AE), the most frequent (≥ 10% overall) being fatigue, hot flush, dyspnoea, nausea, asthenia, headache, constipation, vomiting, and decreased appetite; 33 patients had serious AEs.

CONCLUSION:

Lonaprisan showed limited efficacy as second-line endocrine therapy in postmenopausal women with PR-positive metastatic breast cancer.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00555919.

KEYWORDS:

antiprogestin; breast cancer; lonaprisan; progesterone-receptor antagonist; progesterone-receptor positive

PMID:
23788750
DOI:
10.1093/annonc/mdt216
[Indexed for MEDLINE]
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