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

Primary Purpose

Breast Cancer

Status

Terminated

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Bicalutamide

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring triple negative breast cancer, androgen receptor, bicalutamide

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

Fudan University Shanghai Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

bicalutamide

Arm Description

150mg, po, qd, d1-28

Outcomes

Primary Outcome Measures

Clinical benefit rate (CBR)

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)

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)

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

Evaluate incidence of adverse events and severity grade of these events

Overall Survival (OS)

Overall Survival is defined as the time from enrollment to death from any cause.

Full Information

NCT ID

NCT02348281

First Posted

January 18, 2015

Last Updated

January 21, 2018

Sponsor

Fudan University

1. Study Identification

Unique Protocol Identification Number

NCT02348281

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Terminated

Why Stopped

it's too slow to enroll suitable patients into this study

Study Start Date

January 2015 (undefined)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fudan University

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

triple negative breast cancer, androgen receptor, bicalutamide

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

bicalutamide

Arm Type

Experimental

Arm Description

150mg, po, qd, d1-28

Intervention Type

Drug

Intervention Name(s)

Bicalutamide

Other Intervention Name(s)

Casodex

Intervention Description

150mg, po, qd, d1-28

Primary Outcome Measure Information:

Title

Clinical benefit rate (CBR)

Description

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.

Time Frame

every 8 weeks, up to 48 weeks

Secondary Outcome Measure Information:

Title

Objective response rate (ORR)

Description

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.

Time Frame

every 8 weeks, up to 24 weeks

Title

Progression free survival (PFS)

Description

Progression free survival is defined as the time from enrollment to the first documented disease progression or death from any cause.

Time Frame

every 8 weeks, up to 48 months

Title

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Description

Evaluate incidence of adverse events and severity grade of these events

Time Frame

every 4 weeks, up to 24 weeks

Title

Overall Survival (OS)

Description

Overall Survival is defined as the time from enrollment to death from any cause.

Time Frame

every 3 months, up to 100 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xichun Hu, M.D., Ph.D.

Organizational Affiliation

Fudan University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fudan University Shanghai Cancer Center

City

Shanghai

ZIP/Postal Code

200032

Country

China

12. IPD Sharing Statement

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

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