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

NCT03055312 | Terminated Phase 3 DMC

• 1 other identifier: SYSUCC-007
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

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

Conditions

Metastatic Triple Negative Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Clinical benefit rate for 16 weeks

  The proportion of patients with complete response, partial response and stable disease

  16 weeks

Secondary Outcomes (1)

• progression-free survival

  24 months

Study Arms (2)

TPC chemotherapy

ACTIVE COMPARATOR

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

Drug: TPC

Bicalutamide

EXPERIMENTAL

Bicalutamide 150mg/day every 28 days

Drug: Bicalutamide 150 mg

Interventions

TPC DRUG

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

Also known as: Chemotherapy

TPC chemotherapy

Bicalutamide 150 mg DRUG

Bicalutamide 150mg/day,every 28 days

Also known as: Bicalutamide

Bicalutamide

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (2)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Sun Yat-sen University, Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

Drug Therapy; bicalutamide

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Zhong-Yu Yuan, M.D

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sun Yat-sen University Cancer Center

Study Record Dates

• First Submitted: January 9, 2017
• First Posted: February 16, 2017
• Study Start: December 20, 2016
• Primary Completion: November 15, 2020
• Study Completion: November 15, 2020
• Last Updated: January 28, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)