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Trial record 2 of 263863 for:    ALL

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

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ClinicalTrials.gov Identifier: NCT03405168
Recruitment Status : Recruiting
First Posted : January 19, 2018
Last Update Posted : January 19, 2018
Sponsor:
Information provided by (Responsible Party):

January 14, 2018
January 19, 2018
January 19, 2018
January 10, 2018
June 2018   (Final data collection date for primary outcome measure)
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
Same as current
No Changes Posted
  • treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 30 month ]
    treatment-related adverse events as assessed by CTCAE v4.0
  • 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
  • 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.
Same as current
Not Provided
Not Provided
 
Antibiotic Plus TPC (Treatment of Physician's Choice) in Advanced Breast Cancer
Antibiotic Plus TPC (Treatment of Physician's Choice) in Advanced Breast Cancer
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).
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).
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Advanced Breast Cancer
  • Antibiotic
  • Antibacterial Drug
  • Treatment of Physician's Choice
Drug: Antibiotics
antibiotic drug(choosed by Physicians, dosage: according to the Instructions) plus TPC (Treatment of Physician's Choice).
Experimental: treatment arm
antibiotic drug(choosed by Physicians, dosage: according to the Instructions) plus TPC (Treatment of Physician's Choice).
Intervention: Drug: Antibiotics
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
June 2018
June 2018   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: Female
18 Years to 70 Years   (Adult, Senior)
No
Contact: Zhongyu Yuan +8613631354016 yuanzhy@sysucc.org.cn
China
 
 
NCT03405168
SYSUCC-008
Yes
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
Not Provided
Zhong-yu Yuan, Sun Yat-sen University
Sun Yat-sen University
Not Provided
Study Director: jiajia huang Sun-yatsen University Cancer center
Sun Yat-sen University
January 2018

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