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Ann Oncol. 2016 May;27(5):812-8. doi: 10.1093/annonc/mdw067. Epub 2016 Feb 18.

A phase II trial of abiraterone acetate plus prednisone in patients with triple-negative androgen receptor positive locally advanced or metastatic breast cancer (UCBG 12-1).

Author information

1
Department of Medical Oncology, Institut Bergonié Unicancer, Univ. Bordeaux, INSERM U916, INSERM CIC1401, Bordeaux h.bonnefoi@bordeaux.unicancer.fr.
2
Department of Medical Oncology, Institut Bergonié Unicancer, Univ. Bordeaux, INSERM U916, INSERM CIC1401, Bordeaux.
3
Department of Medical Oncology, Centre Léon Bérard, Lyon.
4
Department of Medical Oncology, Breast Cancer Unit, Gustave Roussy, Villejuif.
5
Department of Medical Oncology, Institut Claudius Regaud, IUCT-Oncopole, Toulouse.
6
Department of Breast Cancer, Centre Oscar Lambret, Lille.
7
Department of Medical Oncology, Centre Hospitalier Départemental Vendée, La Roche sur Yon.
8
Department of Medical Oncology, Institut Curie, PSL Research University, Paris.
9
Department of Medical Oncology, Centre Paul Papin, Angers.
10
Department of Medical Oncology, Teaching Hospital, Lyon-Sud University, Lyon.
11
Department of Medical Oncology, CHU Grenoble, Grenoble.
12
Department of Medical Oncology, Centre Hospitalier Layné, Mont-de-Marsan.
13
Department of Gynecologic Surgery, Hôpital du Leman, Thonon-Les-Bains.
14
Department of Medical Oncology, Centre GF Leclerc, Dijon.
15
Department of Medical Oncology, Institut Curie, St Cloud.
16
Department of Medical Oncology, Institut Sainte-Catherine, Avignon.
17
Department of Pathology, Institut Bergonié, INSERM U916, Bordeaux.
18
UNICANCER R&D, Paris.
19
Clinical and Epidemiological Research Unit, Institut Bergonié, INSERM CIC1401, Bordeaux.
20
Department of Medical Oncology, Institut Paoli-Calmettes, Cancer Research Center of Marseille, INSERM U7258, CNRS U1068, Aix-Marseille Université, Marseille, France.

Abstract

BACKGROUND:

Several expression array studies identified molecular apocrine breast cancer (BC) as a subtype that expresses androgen receptor (AR) but not estrogen receptor α. We carried out a multicentre single-arm phase II trial in women with AR-positive, estrogen, progesterone receptor and HER2-negative (triple-negative) metastatic or inoperable locally advanced BC to assess the efficacy and safety of abiraterone acetate (AA) plus prednisone.

PATIENTS AND METHODS:

Patients with a metastatic or locally advanced, centrally reviewed, triple-negative and AR-positive (≥10% by immunohistochemistry, IHC) BC were eligible. Any number of previous lines of chemotherapy was allowed. AA (1000 mg) was administered once a day with prednisone (5 mg) twice a day until disease progression or intolerance. The primary end point was clinical benefit rate (CBR) at 6 months defined as the proportion of patients presenting a complete response (CR), partial response (PR) or stable disease (SD) ≥6 months. Secondary end points were objective response rate (ORR), progression-free survival (PFS) and safety.

RESULTS:

One hundred and forty-six patients from 27 centres consented for IHC central review. Of the 138 patients with sufficient tissue available, 53 (37.6%) were AR-positive and triple-negative, and 34 of them were included from July 2013 to December 2014. Thirty patients were eligible and evaluable for the primary end point. The 6-month CBR was 20.0% [95% confidence interval (CI) 7.7%-38.6%], including 1 CR and 5 SD ≥6 months, 5 of them still being under treatment at the time of analysis (6.4+, 9.2+, 14.5+, 17.6+, 23.4+ months). The ORR was 6.7% (95% CI 0.8%-22.1%). The median PFS was 2.8 months (95% CI 1.7%-5.4%). Fatigue, hypertension, hypokalaemia and nausea were the most common drug-related adverse events; the majority of them being grade 1 or 2.

CONCLUSIONS:

AA plus prednisone treatment is beneficial for some patients with molecular apocrine tumours and five patients are still on treatment.

CLINICALTRIALSGOV:

NCT01842321.

KEYWORDS:

abiraterone acetate; androgen receptor; breast cancer; molecular apocrine; triple-negative

PMID:
27052658
DOI:
10.1093/annonc/mdw067
[Indexed for MEDLINE]
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