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Trial record 2 of 263863 for:    ALL

Antibiotic Plus TPC (Treatment of Physician's Choice) in Advanced Breast Cancer

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03405168
Recruitment Status : Recruiting
First Posted : January 19, 2018
Last Update Posted : January 19, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This is a phase II,single center,prospective, single arm clinical trials. The objective is to evaluate the efficacy and safety of Antibiotic Plus TPC (Treatment of Physician's Choice) in Advanced Breast Cancer.Primary endpoint is PFS(Progress Free Survival).

Condition or disease Intervention/treatment Phase
Advanced Breast Cancer Antibiotic Antibacterial Drug Treatment of Physician's Choice Drug: Antibiotics Phase 2

Detailed Description:
This is a phase II,single center,prospective, single arm clinical trials. The objective is to evaluate the efficacy and safety of Antibiotic Plus TPC (Treatment of Physician's Choice) in Advanced Breast Cancer.Primary endpoint is PFS(Progress Free Survival).

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Antibiotic Plus TPC (Treatment of Physician's Choice) in Advanced Breast Cancer
Actual Study Start Date : January 10, 2018
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: treatment arm
antibiotic drug(choosed by Physicians, dosage: according to the Instructions) plus TPC (Treatment of Physician's Choice).
Drug: Antibiotics
antibiotic drug(choosed by Physicians, dosage: according to the Instructions) plus TPC (Treatment of Physician's Choice).


Outcome Measures

Primary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: 30 months ]
    Progression is defined as appearance of one or more new lesions. Unequivocal progression of existing non-target lesions. Although a clear progression of "non-target" lesions only is exceptional, in such circumstances, the opinion of the Treating Physician should prevail, and the progression status should be confirmed at a later time by the review panel.the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse


Secondary Outcome Measures :
  1. treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 30 month ]
    treatment-related adverse events as assessed by CTCAE v4.0

  2. Overall Survival [ Time Frame: 30 year ]
    OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date

  3. Objective Response Rate (ORR) [ Time Frame: From date of randomization until the date of first documented progression or date of intolerable toxicity, whichever came first, assessed up to 54 months ]
    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective response (OR) = CR + PR.


Eligibility Criteria

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:

Female ≥ 18 years, ≤70 years. Has measurable MBC, with at least 1 measurable lesion per RECIST criteria. Irradiated lesions cannot be used to assess response but can be used to assess progression.

Receiving first-line or above standard anti-tumor treatment Progress after standard anti-tumor treatment of advanced cancer. Minimum life expectancy 16 weeks Histological confirmation of breast cancer on primary tumour at diagnosis/on biopsy of metastasis ECOG 0-2 with no deterioration over previous 2 weeks Measurable disease Has an ECOG Performance Status (PS) 0-2 Normal organ function If fertile, patient (male or female) has agreed to use an acceptable method of birth control (eg, abstinence, intrauterine device, oral contraceptives, barrier device with spermicide or surgical sterilization) to avoid pregnancy for the duration of the study and for a period of 3 months thereafter.

Has signed a Patient Informed Consent Form Has signed a Patient Authorization Form (HIPAA Form)

Exclusion Criteria:

Last dose chemotherapy, immunotherapy targeted therapy, biological therapy or tumour embolisation <21 days prior to study treatment Last dose of palliative radiotherapy <7 days prior to study treatment Rapidly progressive visceral disease not suitable for further therapy Spinal cord compression or brain/meningeal metastases unless asymptomatic, treated and stable and not requiring steroids for ≥ 4 weeks study treatment Major surgery (excluding placement of vascular access) within 4 weeks before study treatment Evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding diatheses, or active infection including hepatitis B, hepatitis C and HIV With the exception of alopecia, any unresolved toxicities from previous therapy greater than CTCAE grade 1 before study treatment Elevated ALP in absence of bone metastasis Evidence of dementia, altered mental status or any psychiatric condition that would prohibit understanding or rendering of informed consent Participation in another study with investigational product during last 30 days Inability or unwillingness to comply with study procedures, including inability to take regular oral medication

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): NCT03405168


Contacts
Contact: Zhongyu Yuan +8613631354016 yuanzhy@sysucc.org.cn

Locations
China, Guangdong
Zhongyu Yuan Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Zhongyu Yuan    +8613631354016    yuanzhy@sysucc.org.cn   
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Study Director: jiajia huang Sun-yatsen University Cancer center
More Information

Responsible Party: Zhong-yu Yuan, professer, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03405168     History of Changes
Other Study ID Numbers: SYSUCC-008
First Posted: January 19, 2018    Key Record Dates
Last Update Posted: January 19, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents