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

NCT02348281 | Terminated Phase 2 DMC

• 1 other identifier: Fudan BR2015-17
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

triple negative breast cancer; androgen receptor; bicalutamide

Outcome Measures

Primary Outcomes (1)

• Clinical benefit rate (CBR)

  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.

  every 8 weeks, up to 48 weeks

Secondary Outcomes (4)

• Objective response rate (ORR)

  every 8 weeks, up to 24 weeks

• Progression free survival (PFS)

  every 8 weeks, up to 48 months

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  every 4 weeks, up to 24 weeks

• Overall Survival (OS)

  every 3 months, up to 100 months

Study Arms (1)

bicalutamide

EXPERIMENTAL

150mg, po, qd, d1-28

Drug: Bicalutamide

Interventions

Bicalutamide DRUG

150mg, po, qd, d1-28

Also known as: Casodex

bicalutamide

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females elder than 18
• Histological proven unresectable or metastatic breast cancer patients who underwent at least one chemotherapy regimen for metastatic disease
• Patients with androgen Receptor (AR) positive (IHC \>10% nuclear staining) either for primary tumor or metastatic lesion
• 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.
• At least one measurable disease according to the response evaluation criteria in solid tumor (RECIST 1.1)
• Performance status no more than 2
• All patients enrolled are required to have adequate hematologic, hepatic, and renal function
• Life expectancy longer than 12 weeks
• No serious medical history of heart, lung, liver and kidney
• Be able to understand the study procedures and sign informed consent.
• Patients with good compliance

You may not qualify if:

• Pregnant or lactating women
• Women of child-bearing potential, unwilling to use adequate contraceptive protection during the process of the study
• Patients treated with an investigational product within 4 weeks before the enrollment
• Patients who received chemotherapy within 4 weeks before the enrollment
• 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
• 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.
• 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
• Uncontrolled serious infection

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, 200032, China

Location

MeSH Terms

Conditions

Breast Neoplasms; Triple Negative Breast Neoplasms; Bulbo-Spinal Atrophy, X-Linked

Interventions

bicalutamide

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Muscular Atrophy, Spinal; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Motor Neuron Disease; Neuromuscular Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Xichun Hu, M.D., Ph.D.

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.,Ph.D.

Study Record Dates

• First Submitted: January 18, 2015
• First Posted: January 28, 2015
• Study Start: January 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 23, 2018

Record last verified: 2018-01

Locations

CN (1)