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

A Randomized, Multicenter,Phase III Study of Bicalutamide Versus Chemotherapy in First Line Treatment of AR Positive Metastatic Triple Negative Breast Cancer

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03055312

Acronym

SYSUCC-007

Enrollment

Registered

2017-02-16

Start date

2016-12-20

Completion date

2020-11-15

Last updated

2021-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Triple Negative Breast Cancer

Brief summary

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

Detailed 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).

Interventions

DRUGTPC

Conventional chemotherapy(choose a): TX:(Docetaxel 75mg/m2 iv day1 and Capecitabine 950mg/m2 po twice daily days 1-14)every 3 weeks. GT:(Paclitaxel 175mg/m2 iv day1 and Gemcitabine 1250mg/m2 iv days 1 & days 8)every 3 weeks. GC:(Gemcitabine 1000mg/m2 on days 1 & days 8 and Carboplatin by Area Under Curve (AUC) 2 iv on days 1 & days 8) every 3 weeks

DRUGBicalutamide 150 mg

Bicalutamide 150mg/day,every 28 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Clinical benefit rate for 16 weeks	16 weeks	The proportion of patients with complete response, partial response and stable disease

Secondary

Measure	Time frame
progression-free survival	24 months

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026