Decitabine Plus Carboplatin in the Treatment of Metastatic TNBC
NCT ID: NCT03295552
Last Updated: 2022-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
12 participants
INTERVENTIONAL
2017-11-15
2021-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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DC
DNA demethylating agent decitabine plus carboplatin
Decitabine
decitabine 7mg/m2, d1-d5, q3w
Carboplatin
carboplatin AUC = 6, d6, q3w
Interventions
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Decitabine
decitabine 7mg/m2, d1-d5, q3w
Carboplatin
carboplatin AUC = 6, d6, q3w
Eligibility Criteria
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Inclusion Criteria
* Pathologically confirmed metastatic triple negative breast cancer (TNBC). Paraffin-embedded tissue were available from metastatic or primary sites to confirm its TNBC status or for further translational research. TNBC was defined as ER-, PR-, and HER2-.
* Metastatic TNBC should not be treated with more than 1-line for metastatic disease.
* Patients can not be treated with carboplatin in the metastatic setting.
* For patients received carboplatin treatment in the adjuvant setting, they should have at least one year disease interval between last dosage of carboplatin and trial recruiting.
* Patients had at least one measurable lesion according to RECIST criteria version 1.1.
* ECOG Performance Status (PS) of 0-1.
* Adequate liver and renal organ function.
* Dated and signed IEC/IRB-approved informed consent.
Exclusion Criteria
* Less than four weeks since last radiotherapy.
* Pregnancy or lactation or unwillingness to use adequate method of birth control.
* Active or uncontrolled infection.
* Hypersensitivity to carboplatin or decitabine
* Male breast cancer.
* Treated with any DNA demethylating agents
* Young patients with pregnancy or lactation or unwillingness to use adequate method of birth control.
18 Years
70 Years
FEMALE
No
Sponsors
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Shanghai Jiao Tong University School of Medicine
OTHER
Responsible Party
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Kunwei Shen
Professor
Principal Investigators
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Kunwei Shen, MD
Role: PRINCIPAL_INVESTIGATOR
Ruijin Hospital, Shanghai Jiaotong Univeristy School of Medicine
Min Lu, PHD
Role: PRINCIPAL_INVESTIGATOR
Ruijin Hospital, Shanghai Jiaotong Univeristy School of Medicine
Locations
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Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Countries
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Other Identifiers
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RJBC1701
Identifier Type: -
Identifier Source: org_study_id
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