Bicalutamide in Treatment of Androgen Receptor (AR) Positive Metastatic Triple Negative Breast Cancer (SYSUCC-007)

Sun Yat-sen University

Status and phase: Terminated; Phase 3

Conditions: Metastatic Triple Negative Breast Cancer

Treatments: Drug: Bicalutamide 150 mg; Drug: TPC

Study type: Interventional

Funder types: Other

Identifiers

NCT03055312

SYSUCC-007

Details and patient eligibility

About

Compare the efficacy of bicalutamide with conventional chemotherapy (Treatment of Physician's Choice,TPC) in first-line treatment of AR positive metastatic triple negative breast

Full description

This is a phase III,Multi-center,prospective,randomized clinical trials. The objective compare the efficacy of bicalutamide with conventional chemotherapy (Treatment of Physician's Choice,TPC) in first-line treatment of AR positive metastatic triple negative breast cancer.Primary endpoint is 16-week clinical benefit rate (CBR).By centre randomized grouping bicalutamide (experimental Group) or TPC (Control Group).

Enrollment: 36 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age: 18-70 years old, female
• Eastern Cooperative Oncology Group (ECOG) 0 or 1
• Confirmed by pathology or organizing cytology AR positive(IHC：≧10%)triple negative breast cancer
• For the first time recurrence or newly diagnosed advanced breast cancer,Disease-free survival time 12 months above
• Measurable disease per RECIST version 1.1,or immeasurably lesions bone metastasis
• After Recurrence has not received cancer treatment
• Life expectancy of at least 6 months
• Signed and dated an informed consent form

Exclusion criteria

• ECOG score ≧2
• Only brain metastasis or meningeal metastasis
• Receiving other anti-tumor treatment
• Heart,lung,liver,kidney,bone marrow,and other functions badness

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

TPC chemotherapy

Active Comparator group

Description:

Conventional chemotherapy(choose a): TX (Taxotere and Xeloda),GT (Gemcitabine and Paclitaxel),GC (Gemcitabine and Carboplatin)

Treatment:

Drug: TPC

Bicalutamide

Experimental group

Description:

Bicalutamide 150mg/day every 28 days

Treatment:

Drug: Bicalutamide 150 mg