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Bicalutamide as A Treatment in AR-positive Metastatic Triple-Negative Breast Cancer (mTNBC) Patients

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ClinicalTrials.gov Identifier: NCT02348281
Recruitment Status : Terminated (it's too slow to enroll suitable patients into this study)
First Posted : January 28, 2015
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
Xichun Hu, Fudan University

Tracking Information
First Submitted Date  ICMJE January 18, 2015
First Posted Date  ICMJE January 28, 2015
Last Update Posted Date January 23, 2018
Study Start Date  ICMJE January 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 22, 2015)
Clinical benefit rate (CBR) [ Time Frame: every 8 weeks, up to 48 weeks ]
Clinical benefit rate is defined as the percentage of patients who achieve complete response (CR), partial response (PR) and stable disease (SD) ≥24 weeks by RECIST version 1.1 criteria.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02348281 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 22, 2015)
  • Objective response rate (ORR) [ Time Frame: every 8 weeks, up to 24 weeks ]
    Objective response rate is defined as the percentage of patients who achieve complete response (CR) and partial response (PR) by RECIST version 1.1 criteria.
  • Progression free survival (PFS) [ Time Frame: every 8 weeks, up to 48 months ]
    Progression free survival is defined as the time from enrollment to the first documented disease progression or death from any cause.
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: every 4 weeks, up to 24 weeks ]
    Evaluate incidence of adverse events and severity grade of these events
  • Overall Survival (OS) [ Time Frame: every 3 months, up to 100 months ]
    Overall Survival is defined as the time from enrollment to death from any cause.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bicalutamide as A Treatment in AR-positive Metastatic Triple-Negative Breast Cancer (mTNBC) Patients
Official Title  ICMJE A Prospective, Single Center, Phase II Study of Bicalutamide as A Treatment in Androgen Receptor (AR)-Positive Metastatic Triple-Negative Breast Cancer (mTNBC) Patients
Brief Summary This prospective, single center, phase II study is to evaluate the efficacy and safety of bicalutamide as a treatment in androgen receptor (AR)-positive metastatic triple-negative breast cancer (mTNBC) patients.
Detailed Description Triple-negative breast cancer (TNBC) is defined as the absence of estrogen and progesterone receptor expression as well as ERBB2 amplification. It has no response to endocrine or anti-ERBB2 therapies. Recent studies have found some potential therapeutic targets for TNBC. However, it still has a poor outcome. It was reported that TNBC has six subtypes, including 2 basal-like (BL1 and BL2), an immunomodulatory (IM), a mesenchymal (M), a mesenchymal stem-like (MSL), and a luminal androgen receptor (LAR) subtype. Different subtype may be sensitive to different treatment. Bicalutamide is an oral, non-steroidal, androgen receptor (AR) antagonist. It is approved by the Food and Drug Administration (FDA) for the treatment of metastatic prostate cancer. Recently, a study explored the efficacy of bicalutamide in AR positive, estrogen receptor negative metastatic breast cancer (MBC), which showed a high clinical benefit rate (CBR) and a good safety profile. Based on the above reasons, we initiate this phase II study to evaluate the efficacy and safety of bicalutamide in AR positive metastatic triple-negative breast cancer patients.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE Drug: Bicalutamide
150mg, po, qd, d1-28
Other Name: Casodex
Study Arms  ICMJE Experimental: bicalutamide
150mg, po, qd, d1-28
Intervention: Drug: Bicalutamide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 3, 2017)
1
Original Estimated Enrollment  ICMJE
 (submitted: January 22, 2015)
44
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Females elder than 18
  2. Histological proven unresectable or metastatic breast cancer patients who underwent at least one chemotherapy regimen for metastatic disease
  3. Patients with androgen Receptor (AR) positive (IHC >10% nuclear staining) either for primary tumor or metastatic lesion
  4. Triple-negative for estrogen receptor (ER), progestogen receptor (PR), and human epithelial receptor-2 (HER2) by IHC (ER <1%, PR <1% and Her2 negative). A negative Her2 gene amplification should be verified by FISH test for those patients with Her2 (2+). For those with Her2 (1+), FISH test might be considered by the investigator.
  5. At least one measurable disease according to the response evaluation criteria in solid tumor (RECIST 1.1)
  6. Performance status no more than 2
  7. All patients enrolled are required to have adequate hematologic, hepatic, and renal function
  8. Life expectancy longer than 12 weeks
  9. No serious medical history of heart, lung, liver and kidney
  10. Be able to understand the study procedures and sign informed consent.
  11. Patients with good compliance

Exclusion Criteria:

  1. Pregnant or lactating women
  2. Women of child-bearing potential, unwilling to use adequate contraceptive protection during the process of the study
  3. Patients treated with an investigational product within 4 weeks before the enrollment
  4. Patients who received chemotherapy within 4 weeks before the enrollment
  5. Patients with symptomatic central nervous system metastases are not permitted, except for those with stable and asymptomatic brain metastases who have completed cranial irradiation, and have at least one measurable lesion outside the brain. Radiotherapy should be completed within 4 weeks prior to the registration
  6. Other active malignancies (including other hematologic malignancies) or other malignancies within the last 5 years, except for cured nonmelanoma skin cancer or cervical intraepithelial neoplasia.
  7. Patients having a history of clinically significant cardiovascular, hepatic, respiratory or renal diseases, clinically significant hematological and endocrinal abnormalities, clinically significant neurological or psychiatric conditions
  8. Uncontrolled serious infection
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02348281
Other Study ID Numbers  ICMJE Fudan BR2015-17
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Xichun Hu, Fudan University
Study Sponsor  ICMJE Fudan University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Xichun Hu, M.D., Ph.D. Fudan University
PRS Account Fudan University
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP