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Trial record 55 of 103 for:    "Kennedy disease"

Bicalutamide Plus Aromatase Inhibitors in ER(+)/AR(+)/HER2(-) Metastatic Breast Cancer (BETTER)

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ClinicalTrials.gov Identifier: NCT02910050
Recruitment Status : Recruiting
First Posted : September 21, 2016
Last Update Posted : December 22, 2017
Sponsor:
Collaborator:
Sun Yat-sen University
Information provided by (Responsible Party):
Xu fei, Sun Yat-sen University

Brief Summary:
This study is aim to evaluate the efficacy and safety of bicalutamide and aromatase inhibitor in ER(+)/AR(+)/HER2(-) metastatic breast cancer patients who have disease progression after treatment of an aromatase inhibitor.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Bicalutamide Drug: Aromatase Inhibitor Phase 2

Detailed Description:
Androgen receptor(AR) is closely related to molecular type, treatment and prognosis in breast cancer. Over 70% of breast cancer expressed androgen receptor. And in some estrogen receptor positive breast cancer cells which are resistant to Aromatase inhibitors can change androgen receptor dependent. So AR may be a new target in the treatment of breast cancer. Bicalutamide is a selective androgen receptor inhibitor with a clinical benefit rate of 19% and median progression free survival of 12 weeks in the ER-/AR+ metastatic breast cancer. This study is aim to evaluate the efficacy and safety of bicalutamide and aromatase inhibitor in ER+/AR+/HER- metastatic breast cancer patients who have disease progression after treatment of an AI.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of the Efficacy and Tolerability of Bicalutamide Plus Aromatase Inhibitors in Estrogen Receptor(+)/Androgen Receptor(+)/HER2(-) Metastatic Breast Cancer
Study Start Date : January 2016
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: bicalutamide+ Aromatase Inhibitor
ER(+)/AR(+)/HER2(+) metastatic breast cancer patients that previously treated by an aromatase inhibitor
Drug: Bicalutamide
50mg once a day orally
Other Name: Casodex

Drug: Aromatase Inhibitor
participants will receive any kind of aromatase inhibitor which has not been received before (steroidal AI change to nonsteroidal AI and vice versa), Letrozole 2.5mg once a day orally, Anastrozole 1mg once a day orally, Exemestane 25mg once a day orally
Other Names:
  • letrozole
  • anastrozole
  • exemestane




Primary Outcome Measures :
  1. clinical benefit rate(CBR) [ Time Frame: 24 weeks ]
    Response and progression will be evaluated using RECIST 1.1. Evaluation will occur every 2 months for the first 6 months and then every 3 months till progression or termination of the study.CBR is defined as ratio of participants who have stable disease for over 24 weeks.


Secondary Outcome Measures :
  1. progression free survival [ Time Frame: baseline up to approximately 6 months ]
    Time from to the first documentation of objective tumor progression or to death due to any cause.

  2. objective response rate of bicalutamide plus another AI in participants with measurable disease [ Time Frame: 24 weeks ]
    objective response rate includes complete response, partial response.

  3. tolerability of bicalutamide plus an Aromatase inhibitor [ Time Frame: 2 years ]
    evaluate and quality of life of the participants using Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) .



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with histologically confirmed estrogen receptor positive, androgen positive and HER2 negative breast cancer
  • Metastatic or unresectable locally advanced disease
  • Age over 18 years
  • Postmenopausal status (continuous using luteinizing hormone releasing hormone(LHRH) analogue is available)
  • Patient must have disease progression after treatment of an Aromatase inhibitor.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS)0-2
  • Life expectancy over 3 months.
  • Measurable disease according to RECIST version 1.1 or only bone metastasis
  • Adequate hematological, hepatic function.
  • Voluntarily signed and dated written informed consent prior to any study specific procedure.

Exclusion Criteria:

  • Patient with life-threatening visceral metastasis, such as extensive liver metastasis, brain or meningeal metastasis
  • Concomitant diseases/conditions that is not controllable, and Any other major illness that, in the Investigator's judgment, will substantially increase the risk associated with the patient's participation in this study.
  • History of other primary malignancy
  • Resistant to steroidal or nonsteroidal aromatase Inhibitor

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): NCT02910050


Contacts
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Contact: Fei Xu, MD +86-13711277870 xiawen@sysucc.org.cn

Locations
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China, Guangdong
State Key Laboratory of Oncology in South China,Sun Yat-sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Fei Xu, MD    +86-13711277870    xufei@sysucc.org.cn   
Sponsors and Collaborators
Xu fei
Sun Yat-sen University
Investigators
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Principal Investigator: Fei Xu, MD Sun Yat-sen University

Publications:

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Responsible Party: Xu fei, associate chief physician,associate professor,MD, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02910050     History of Changes
Other Study ID Numbers: SYSU5010-2016
First Posted: September 21, 2016    Key Record Dates
Last Update Posted: December 22, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Xu fei, Sun Yat-sen University:
androgen receptor
bicalutamide
aromatase inhibitors
advanced breast cancer
letrozole
anastrozole
exemestane

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Letrozole
Exemestane
Anastrozole
Bicalutamide
Aromatase Inhibitors
Androgens
Antineoplastic Agents
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Hormones
Antineoplastic Agents, Hormonal
Androgen Antagonists