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

This study has been terminated.
(it's too slow to enroll suitable patients into this study)
Sponsor:
ClinicalTrials.gov Identifier:
NCT02348281
First Posted: January 28, 2015
Last Update Posted: January 5, 2017
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.
Information provided by (Responsible Party):
Xichun Hu, Fudan University
  Purpose
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.

Condition Intervention Phase
Breast Cancer Drug: Bicalutamide Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Single Center, Phase II Study of Bicalutamide as A Treatment in Androgen Receptor (AR)-Positive Metastatic Triple-Negative Breast Cancer (mTNBC) Patients

Resource links provided by NLM:


Further study details as provided by Xichun Hu, Fudan University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 1
Study Start Date: January 2015
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: bicalutamide
150mg, po, qd, d1-28
Drug: Bicalutamide
150mg, po, qd, d1-28
Other Name: Casodex

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.
  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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): NCT02348281


Locations
China
Fudan University Shanghai Cancer Center
Shanghai, China, 200032
Sponsors and Collaborators
Fudan University
Investigators
Principal Investigator: Xichun Hu, M.D., Ph.D. Fudan University
  More Information

Responsible Party: Xichun Hu, M.D.,Ph.D., Fudan University
ClinicalTrials.gov Identifier: NCT02348281     History of Changes
Other Study ID Numbers: Fudan BR2015-17
First Submitted: January 18, 2015
First Posted: January 28, 2015
Last Update Posted: January 5, 2017
Last Verified: January 2017

Keywords provided by Xichun Hu, Fudan University:
triple negative breast cancer
androgen receptor
bicalutamide

Additional relevant MeSH terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Androgens
Bicalutamide
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Androgen Antagonists
Hormone Antagonists
Antineoplastic Agents