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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03055312
Recruitment Status : Terminated
First Posted : February 16, 2017
Last Update Posted : January 28, 2021
Sponsor:
Information provided by (Responsible Party):
Zhong-yu Yuan, Sun Yat-sen University

Study Description
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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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 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
Actual Study Start Date : December 20, 2016
Actual Primary Completion Date : November 15, 2020
Actual Study Completion Date : November 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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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


Outcome Measures
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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 ]

Eligibility Criteria
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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
Contacts and Locations
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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


Locations
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China, Guangdong
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Sun Yat-sen University, Cancer Center
Guangzhou, Guangdong, China, 510060
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Principal Investigator: Zhong-Yu Yuan, M.D Sun Yat-sen University
More Information
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Responsible Party: Zhong-yu Yuan, Sun Yat-sen University Cancer Center, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03055312    
Other Study ID Numbers: SYSUCC-007
First Posted: February 16, 2017    Key Record Dates
Last Update Posted: January 28, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
 Bicalutamide
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents