Bicalutamide as A Treatment in AR-positive Metastatic Triple-Negative Breast Cancer (mTNBC) Patients

Sponsor

Fudan University (Other)

Overall Status

Terminated

CT.gov ID

NCT02348281

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This prospective, single center, phase II study is to evaluate the efficacy and safety of bicalutamide as a treatment in androgen receptor (AR)-positive metastatic triple-negative breast cancer (mTNBC) patients.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Drug: Bicalutamide	Phase 2

Detailed Description

Triple-negative breast cancer (TNBC) is defined as the absence of estrogen and progesterone receptor expression as well as ERBB2 amplification. It has no response to endocrine or anti-ERBB2 therapies. Recent studies have found some potential therapeutic targets for TNBC. However, it still has a poor outcome. It was reported that TNBC has six subtypes, including 2 basal-like (BL1 and BL2), an immunomodulatory (IM), a mesenchymal (M), a mesenchymal stem-like (MSL), and a luminal androgen receptor (LAR) subtype. Different subtype may be sensitive to different treatment. Bicalutamide is an oral, non-steroidal, androgen receptor (AR) antagonist. It is approved by the Food and Drug Administration (FDA) for the treatment of metastatic prostate cancer. Recently, a study explored the efficacy of bicalutamide in AR positive, estrogen receptor negative metastatic breast cancer (MBC), which showed a high clinical benefit rate (CBR) and a good safety profile. Based on the above reasons, we initiate this phase II study to evaluate the efficacy and safety of bicalutamide in AR positive metastatic triple-negative breast cancer patients.

Study Design

Study Type:

Interventional

Actual Enrollment :

1 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Prospective, Single Center, Phase II Study of Bicalutamide as A Treatment in Androgen Receptor (AR)-Positive Metastatic Triple-Negative Breast Cancer (mTNBC) Patients

Study Start Date :

Jan 1, 2015

Actual Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: bicalutamide 150mg, po, qd, d1-28	Drug: Bicalutamide 150mg, po, qd, d1-28 Other Names: Casodex

Arm

Intervention/Treatment

Experimental: bicalutamide

150mg, po, qd, d1-28

Drug: Bicalutamide

150mg, po, qd, d1-28

Other Names:

Casodex

Outcome Measures

Primary Outcome Measures

Clinical benefit rate (CBR) [every 8 weeks, up to 48 weeks]
Clinical benefit rate is defined as the percentage of patients who achieve complete response (CR), partial response (PR) and stable disease (SD) ≥24 weeks by RECIST version 1.1 criteria.

Secondary Outcome Measures

Objective response rate (ORR) [every 8 weeks, up to 24 weeks]
Objective response rate is defined as the percentage of patients who achieve complete response (CR) and partial response (PR) by RECIST version 1.1 criteria.
Progression free survival (PFS) [every 8 weeks, up to 48 months]
Progression free survival is defined as the time from enrollment to the first documented disease progression or death from any cause.
Number of Participants with Adverse Events as a Measure of Safety and Tolerability [every 4 weeks, up to 24 weeks]
Evaluate incidence of adverse events and severity grade of these events
Overall Survival (OS) [every 3 months, up to 100 months]
Overall Survival is defined as the time from enrollment to death from any cause.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Females elder than 18
Histological proven unresectable or metastatic breast cancer patients who underwent at least one chemotherapy regimen for metastatic disease
Patients with androgen Receptor (AR) positive (IHC >10% nuclear staining) either for primary tumor or metastatic lesion
Triple-negative for estrogen receptor (ER), progestogen receptor (PR), and human epithelial receptor-2 (HER2) by IHC (ER <1%, PR <1% and Her2 negative). A negative Her2 gene amplification should be verified by FISH test for those patients with Her2 (2+). For those with Her2 (1+), FISH test might be considered by the investigator.
At least one measurable disease according to the response evaluation criteria in solid tumor (RECIST 1.1)
Performance status no more than 2
All patients enrolled are required to have adequate hematologic, hepatic, and renal function
Life expectancy longer than 12 weeks
No serious medical history of heart, lung, liver and kidney
Be able to understand the study procedures and sign informed consent.
Patients with good compliance

Exclusion Criteria:

Pregnant or lactating women
Women of child-bearing potential, unwilling to use adequate contraceptive protection during the process of the study
Patients treated with an investigational product within 4 weeks before the enrollment
Patients who received chemotherapy within 4 weeks before the enrollment
Patients with symptomatic central nervous system metastases are not permitted, except for those with stable and asymptomatic brain metastases who have completed cranial irradiation, and have at least one measurable lesion outside the brain. Radiotherapy should be completed within 4 weeks prior to the registration
Other active malignancies (including other hematologic malignancies) or other malignancies within the last 5 years, except for cured nonmelanoma skin cancer or cervical intraepithelial neoplasia.
Patients having a history of clinically significant cardiovascular, hepatic, respiratory or renal diseases, clinically significant hematological and endocrinal abnormalities, clinically significant neurological or psychiatric conditions
Uncontrolled serious infection