Clinical trial NCT02910050: Bicalutamide Plus Aromatase Inhibitors in ER(+)/AR(+)/HER2(-) Metastatic Breast Cancer
Official title: A Phase II Study of the Efficacy and Tolerability of Bicalutamide Plus Aromatase Inhibitors in Estrogen Receptor(+)/Androgen Receptor(+)/HER2(-) Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Breast Cancer
Keywords: androgen receptor
bicalutamide
aromatase inhibitors
advanced breast cancer
letrozole
anastrozole
exemestane
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Sun Yat-sen University
First posted: 2016-09-21
Enrollment: 58
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is aim to evaluate the efficacy and safety of bicalutamide and aromatase inhibitor in ER(+)/AR(+)/HER2(-) metastatic breast cancer patients who have disease progression after treatment of an aromatase inhibitor.

Detailed description: Androgen receptor(AR) is closely related to molecular type, treatment and prognosis in breast cancer. Over 70% of breast cancer expressed androgen receptor. And in some estrogen receptor positive breast cancer cells which are resistant to Aromatase inhibitors can change androgen receptor dependent. So AR may be a new target in the treatment of breast cancer. Bicalutamide is a selective androgen receptor inhibitor with a clinical benefit rate of 19% and median progression free survival of 12 weeks in the ER-/AR+ metastatic breast cancer. This study is aim to evaluate the efficacy and safety of bicalutamide and aromatase inhibitor in ER+/AR+/HER- metastatic breast cancer patients who have disease progression after treatment of an AI.

Eligibility criteria: Inclusion Criteria:

* Patients with histologically confirmed estrogen receptor positive, androgen positive and HER2 negative breast cancer
* Metastatic or unresectable locally advanced disease
* Age over 18 years
* Postmenopausal status （continuous using luteinizing hormone releasing hormone(LHRH) analogue is available）
* Patient must have disease progression after treatment of an Aromatase inhibitor.
* Eastern Cooperative Oncology Group (ECOG) performance status (PS)0-2
* Life expectancy over 3 months.
* Measurable disease according to RECIST version 1.1 or only bone metastasis
* Adequate hematological, hepatic function.
* Voluntarily signed and dated written informed consent prior to any study specific procedure.

Exclusion Criteria:

* Patient with life-threatening visceral metastasis, such as extensive liver metastasis, brain or meningeal metastasis
* Concomitant diseases/conditions that is not controllable, and Any other major illness that, in the Investigator's judgment, will substantially increase the risk associated with the patient's participation in this study.
* History of other primary malignancy
* Resistant to steroidal or nonsteroidal aromatase Inhibitor

Primary outcomes:
measure: clinical benefit rate（CBR）
timeFrame: 24 weeks
Secondary outcomes:
measure: progression free survival
timeFrame: baseline up to approximately 6 months
measure: objective response rate of bicalutamide plus another AI in participants with measurable disease
timeFrame: 24 weeks
measure: tolerability of bicalutamide plus an Aromatase inhibitor
timeFrame: 2 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: State Key Laboratory of Oncology in South China,Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Fei Xu, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Lu Q, Xia W, Lee K, Zhang J, Yuan H, Yuan Z, Shi Y, Wang S, Xu F. Bicalutamide plus Aromatase Inhibitor in Patients with Estrogen Receptor-Positive/Androgen Receptor-Positive Advanced Breast Cancer. Oncologist. 2020 Jan;25(1):21-e15. doi: 10.1634/theoncologist.2019-0564. Epub 2019 Aug 21.