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

Metastatic Triple Negative Breast Cancer Clinical Trial

— SYSUCC-007  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03055312
• Other study ID #: SYSUCC-007
• Status: Terminated
• Phase: Phase 3
• Start date: December 20, 2016
• Est. completion date: November 15, 2020

Study information

• Verified date: January 2021
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 36
• Est. completion date: November 15, 2020
• Est. primary completion date: November 15, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Triple Negative Breast Cancer
• Triple Negative Breast Neoplasms

Intervention

Drug:
• TPC
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
• Bicalutamide 150 mg
Bicalutamide 150mg/day,every 28 days

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong
China	Sun Yat-sen University, Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical benefit rate for 16 weeks	The proportion of patients with complete response, partial response and stable disease	16 weeks
Secondary	progression-free survival		24 months