Clinical Trials /

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

NCT02910050

Description:

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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Unknown status

Phase:

Phase 2

URL:

https://clinicaltrials.gov/show/NCT02910050

Trial Eligibility

Document

Title

  • Brief Title: Bicalutamide Plus Aromatase Inhibitors in ER(+)/AR(+)/HER2(-) Metastatic Breast Cancer
  • 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

Clinical Trial IDs

  • ORG STUDY ID: SYSU5010-2016
  • NCT ID: NCT02910050

Conditions

  • Breast Cancer

Interventions

DrugSynonymsArms
BicalutamideCasodexbicalutamide+ Aromatase Inhibitor
Aromatase Inhibitorletrozole, anastrozole, exemestanebicalutamide+ Aromatase Inhibitor

Purpose

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.

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.

Trial Arms

NameTypeDescriptionInterventions
bicalutamide+ Aromatase InhibitorExperimentalER(+)/AR(+)/HER2(+) metastatic breast cancer patients that previously treated by an aromatase inhibitor
  • Bicalutamide
  • Aromatase Inhibitor

Eligibility 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
Maximum Eligible Age:80 Years
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:clinical benefit rate（CBR）
Time Frame:24 weeks
Safety Issue:
Description: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

Measure:progression free survival
Time Frame:baseline up to approximately 6 months
Safety Issue:
Description:Time from to the first documentation of objective tumor progression or to death due to any cause.
Measure:objective response rate of bicalutamide plus another AI in participants with measurable disease
Time Frame:24 weeks
Safety Issue:
Description:objective response rate includes complete response, partial response.
Measure:tolerability of bicalutamide plus an Aromatase inhibitor
Time Frame:2 years
Safety Issue:
Description:evaluate and quality of life of the participants using Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) .

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Unknown status
Lead Sponsor:Xu fei

Trial Keywords

  • androgen receptor
  • bicalutamide
  • aromatase inhibitors
  • advanced breast cancer
  • letrozole
  • anastrozole
  • exemestane

Last Updated

December 22, 2017