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

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ClinicalTrials.gov Identifier: NCT03055312
Recruitment Status : Recruiting
First Posted : February 16, 2017
Last Update Posted : September 11, 2017
Sponsor:
Information provided by (Responsible Party):
Zhong-yu Yuan, Sun Yat-sen University

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

Condition or disease Intervention/treatment Phase
Metastatic Triple Negative Breast Cancer Drug: TPC Drug: Bicalutamide 150 mg Phase 3

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).

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 262 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Randomized, Multicenter,Phase III Study of Bicalutamide Versus Chemotherapy in First Line Treatment of AR Positive Metastatic Triple Negative Breast Cancer
Study Start Date : December 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Active Comparator: TPC chemotherapy

Conventional chemotherapy(choose a):

TX (Taxotere and Xeloda),GT (Gemcitabine and Paclitaxel),GC (Gemcitabine and Carboplatin)

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

Other Name: Chemotherapy

Experimental: Bicalutamide
Bicalutamide 150mg/day every 28 days
Drug: Bicalutamide 150 mg
Bicalutamide 150mg/day,every 28 days
Other Name: Bicalutamide




Primary Outcome Measures :
  1. Clinical benefit rate for 16 weeks [ Time Frame: 16 weeks ]
    The proportion of patients with complete response, partial response and stable disease


Secondary Outcome Measures :
  1. progression-free survival [ Time Frame: 24 months ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03055312


Contacts
Contact: Zhong-Yu Yuan, M.D 86-20-87342496 yuanzhy@sysucc.org.cn
Contact: Jia-Jia Huang, M.D 86-20-87343794 huangjiaj@sysucc.org.cn

Locations
China, Guangdong
Sun Yat-sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Zhong-yu Yuan, MD    86-20-87342496    yuanzhy@sysucc.org.cn   
Contact: Yong-yi Zhong, BD    86-20-87342635    zhongyy@sysucc.org.cn   
Sun Yat-sen University, Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Yuan Zhong-yu, MD    86-20-87342496    yuanzhy@sysucc.org.cn   
Contact: Huang Jia-Jia, MD    86-20-87343794    huangjiaj@sysucc.org.cn   
Principal Investigator: Yuan Zhong-yu, MD         
Sub-Investigator: Huang Jia-Jia, MD         
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Principal Investigator: Zhong-Yu Yuan, M.D Sun Yat-sen University

Responsible Party: Zhong-yu Yuan, Sun Yat-sen University Cancer Center, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03055312     History of Changes
Other Study ID Numbers: SYSUCC-007
First Posted: February 16, 2017    Key Record Dates
Last Update Posted: September 11, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Gemcitabine
Bicalutamide
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists